xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06011538</url>
    </required_header>
    <id_info>
      <org_study_id>BirminghamWCNHSFT</org_study_id>
      <nct_id>NCT06011538</nct_id>
    </id_info>
    <brief_title>Web-based Versus Standard Information for Same Day Hysterectomy (WISH)</brief_title>
    <acronym>WISH</acronym>
    <official_title>The WISH Trial (Web-based Versus Standard Information for Same Day Hysterectomy)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Birmingham Women's and Children's NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Birmingham Women's and Children's NHS Foundation Trust</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Objectives: To evaluate the potential utility and efficacy of additional on-line, patient&#xD;
        education resource for same day discharge following laparoscopic hysterectomy (SDD LH)&#xD;
        compared to standard information resources alone&#xD;
  &#xD;
        Trial Design: A pilot, parallel, open, single centre, randomised controlled trial&#xD;
  &#xD;
        Participant Population and Sample Size: 40 women undergoing SDD LH for a benign reason&#xD;
  &#xD;
        Eligibility Criteria: Women with gynaecological conditions requiring a laparoscopic&#xD;
        hysterectomy (LH) and who are suitable for same day discharge (SDD).&#xD;
  &#xD;
        Interventions: An online patient education website resource and the comparator is standard&#xD;
        practice for provision of patient information (written and verbal).&#xD;
  &#xD;
        Outcome Measures:&#xD;
  &#xD;
        Primary&#xD;
  &#xD;
          -  Compliance with SDD Secondary&#xD;
  &#xD;
          -  In Hospital:&#xD;
  &#xD;
             o Surgical details / complexity / intraoperative and post-operative serious adverse&#xD;
             events (SAEs) according to the Clavien-Dindo system grade II-IV which is a widely used&#xD;
             index for the classification of surgical complications [case notes and electronic&#xD;
             patient record], and time to discharge&#xD;
  &#xD;
          -  6 weeks:&#xD;
  &#xD;
               -  Satisfaction, acceptability and utility of patient education / information provided&#xD;
                  (bespoke patient questionnaire; Likert scales)&#xD;
  &#xD;
               -  Satisfaction with care after LH (6-point Likert)&#xD;
  &#xD;
               -  Generic quality of life at 6 weeks post-surgery (EuroQol-5D-5L and VAS);&#xD;
  &#xD;
               -  Contact with Community &amp; Clinical Care Services i.e. outpatients or emergency&#xD;
                  visits, re-presentations / re-admissions to hospital (Case report form [CRF], case&#xD;
                  notes, electronic patient record)&#xD;
  &#xD;
               -  Serious Adverse Events (CRF, case notes, electronic patient record)&#xD;
  &#xD;
               -  Time from surgery to resumption of usual activities using the PROMIS-SF&#xD;
                  (Patient-Reported Outcomes Measurement Information System Physical Function)&#xD;
                  questionnaire (Modified items / response categories)&#xD;
  &#xD;
          -  12 weeks:&#xD;
  &#xD;
               -  Time from surgery to resumption of usual activities using the PROMIS-SF&#xD;
                  (Patient-Reported Outcomes Measurement Information System Physical Function)&#xD;
                  questionnaire (Modified items / response categories) Time to return to work (if&#xD;
                  working)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Aim:&#xD;
  &#xD;
        To evaluate the potential efficacy of additional on-line, patient education for SDD LH in&#xD;
        achieving SDD compared to standard information giving. In addition, the utility and&#xD;
        acceptability of patient information will be assessed as well as the impact on patient&#xD;
        satisfaction and recovery.&#xD;
  &#xD;
        Objectives:&#xD;
  &#xD;
        The investigators aim to assess various aspects of trial management and design. In order to&#xD;
        achieve this, the objectives of the pilot randomised controlled trial (RCT) will be split&#xD;
        into:&#xD;
  &#xD;
          -  Process Objectives&#xD;
  &#xD;
               -  To determine the proportion of eligible women that are screened and meet the&#xD;
                  inclusion criteria&#xD;
  &#xD;
               -  To determine the proportion of eligible women that agree to be randomised&#xD;
  &#xD;
               -  To determine the robustness of proposed data collection tools; completion and&#xD;
                  return rates&#xD;
  &#xD;
          -  Clinical Objectives&#xD;
  &#xD;
               -  To determine the appropriateness of the outcome measures&#xD;
  &#xD;
               -  To derive clinical data to help inform the sample size for a future substantive&#xD;
                  study (the potential efficacy of additional on-line, patient education for SDD LH&#xD;
                  in achieving SDD compared to standard information giving).&#xD;
  &#xD;
        Trial design and setting&#xD;
  &#xD;
        Trial design:&#xD;
  &#xD;
        A pilot, parallel, open, single centre, randomised controlled trial.&#xD;
  &#xD;
        Trial Setting:&#xD;
  &#xD;
        Recruitment to the Web-based Versus Standard Information for Same Day Hysterectomy (WISH)&#xD;
        study will take place in gynaecology departments (general and relevant specialist clinics&#xD;
        including menstrual disorders and pelvic pain clinics, hysteroscopy and colposcopy services)&#xD;
        in an NHS, University-affiliated Teaching Hospital (Birmingham Women's &amp; Children's Hospital&#xD;
        (BWCH) in the UK.&#xD;
  &#xD;
        Identification of participants:&#xD;
  &#xD;
        Eligible women will be identified by a member of the clinical team responsible for the direct&#xD;
        care of the potential participant in outpatient gynaecology clinics and pre-operative&#xD;
        assessment clinics in each recruiting centre. Additionally, patients already on the waiting&#xD;
        list for SDD LH will be identified and invited to participate. The study will be introduced&#xD;
        by a member of the clinical or research team, with full counselling about the trial. The&#xD;
        potential participant will be advised that participation in the study is entirely voluntary&#xD;
        with the option of withdrawing from the study at any stage. It will be made clear that&#xD;
        participation or non-participation will not affect their usual care.&#xD;
  &#xD;
        Assessment of Risk:&#xD;
  &#xD;
        SDD LH is routinely practiced at the BWCH. Verbal and written, paper-based information is&#xD;
        provided. This study provides additional, on-line, multi-media information on a specifically&#xD;
        designed website for SDD LH. Thus, this trial is categorised as: Type A = No higher than the&#xD;
        risk of standard medical care.&#xD;
  &#xD;
        Eligibility&#xD;
  &#xD;
        Women are eligible for recruitment if they meet the inclusion criteria and do not have any of&#xD;
        the exclusion criteria set out below:&#xD;
  &#xD;
        Inclusion Criteria:&#xD;
  &#xD;
          -  Able to give informed consent to participate&#xD;
  &#xD;
          -  Have a benign gynaecological condition that is being treated with a LH&#xD;
  &#xD;
          -  Eligible to be on same day discharge pathway Patient factors&#xD;
  &#xD;
               -  American Society of Anesthesiologists (ASA) physical status classification I/II&#xD;
                  with no sleep apnoea. ASA III may be suitable if comorbidities are stable and&#xD;
                  optimised.&#xD;
  &#xD;
               -  No known cardio-pulmonary compromise&#xD;
  &#xD;
               -  No known renal disease&#xD;
  &#xD;
               -  Age &lt;/=60 years&#xD;
  &#xD;
               -  BMI &lt;/=40&#xD;
  &#xD;
               -  Not indication for admission to Gynaecological Extended Recovery Area (GERU)&#xD;
                  Surgical factors&#xD;
  &#xD;
               -  Presumed benign disease&#xD;
  &#xD;
               -  No anticipated surgical complications&#xD;
  &#xD;
               -  Concomitant procedures acceptable but surgeon to decide on a case by case basis&#xD;
                  Discharge factors&#xD;
  &#xD;
               -  Residence &lt; 1 hour from BWCH&#xD;
  &#xD;
               -  Access to transport from hospital to home&#xD;
  &#xD;
        Exclusion Criteria:&#xD;
  &#xD;
          -  Patient above the age of 60&#xD;
  &#xD;
          -  Unwillingness or inability to comply with protocol procedures&#xD;
  &#xD;
          -  Women who require concomitant gynaecological surgery for bladder or other pelvic support&#xD;
  &#xD;
          -  Women who require concomitant gynaecological surgery for excision of deep endometriosis&#xD;
             that requires dissection of the pararectal space&#xD;
  &#xD;
        Consent&#xD;
  &#xD;
        It will be the responsibility of the Investigator to obtain informed consent for each&#xD;
        participant prior to performing any trial related procedure. A research nurse, research&#xD;
        midwife or clinician is able to take consent providing that local practice allows this and&#xD;
        responsibility has been delegated by the Principal Investigator as captured on the Site&#xD;
        Signature and Delegation Log.&#xD;
  &#xD;
        A Participant Information Sheet (PIS) will be provided to facilitate this process either at&#xD;
        the time of initial consultation / hospital visit or sent through the post, via email, or by&#xD;
        text as an attachment. Investigators or their delegate(s) will ensure that they adequately&#xD;
        explain the aim, trial treatment, anticipated benefits and potential hazards of taking part&#xD;
        in the trial to the participant. They will also stress that participation is voluntary and&#xD;
        that the participant is free to decline to take part and may withdraw from the trial at any&#xD;
        time. The participant will be given sufficient time to read the PIS and to discuss their&#xD;
        participation with others outside of the site research team. The participant will be given&#xD;
        the opportunity to ask questions. Where direct access to patient medical records is required&#xD;
        the participant will give explicit consent for the regulatory authorities, members of the&#xD;
        research team and or representatives of the sponsor to be given direct access to their&#xD;
        medical records.&#xD;
  &#xD;
        The Investigator or their delegate will then countersign and date the informed consent form&#xD;
        (ICF). A copy of the ICF will be given to the participant (hard copy), a copy will be filed&#xD;
        in the medical notes, and the original placed in the Investigator Site File (ISF). Once the&#xD;
        participant is entered into the trial, the participant's trial number will be entered on the&#xD;
        ICF maintained in the ISF.&#xD;
  &#xD;
        Details of the informed consent discussions will be recorded in the participant's medical&#xD;
        notes. This will include date of discussion, the name of the trial, summary of discussion,&#xD;
        version number of the PIS given to participant and version number of ICF signed and date&#xD;
        consent received. Where consent is obtained on the same day that the trial related&#xD;
        assessments are due to start, a note should be made in the medical notes as to what time the&#xD;
        consent was obtained and what time the procedures started.&#xD;
  &#xD;
        Throughout the trial the participant will have the opportunity to ask questions about the&#xD;
        trial. Any new information that may be relevant to the participant's continued participation&#xD;
        will be provided. Where new information becomes available which may affect the participants'&#xD;
        decision to continue, participants will be given time to consider and if happy to continue&#xD;
        will be re-consented. Re-consent will be documented in the medical notes. The participant's&#xD;
        right to withdraw from the trial at any time will remain.&#xD;
  &#xD;
        Details of all patients approached about the trial will be recorded on the Participant&#xD;
        Screening/Enrolment Log.&#xD;
  &#xD;
        Recruitment, enrolment and randomisation&#xD;
  &#xD;
        Recruitment:&#xD;
  &#xD;
        Potential participants will be identified and approached by medical staff who are responsible&#xD;
        for the direct care of the potential participant after having received appropriate training&#xD;
        relating to the trial and who are delegated this task on the site delegation log. Recruitment&#xD;
        will take place in gynaecology clinics in gynaecologist lead centres located across the&#xD;
        United Kingdom.&#xD;
  &#xD;
        The participant eligibility pathway to recruitment and randomisation is illustrated by the&#xD;
        trial schema. Eligibility will be confirmed following discussions with the woman and a review&#xD;
        of her medical notes by staff delegated this duty by the local principle investigator (PI).&#xD;
  &#xD;
        Potential participants will be advised that taking part in the study is entirely voluntary&#xD;
        and they may withdraw from the study at any stage without this affecting their usual care.&#xD;
        Potential participants will be provided with a research ethics committee (REC) approved Study&#xD;
        Participant Information Sheet (PIS) and given time to consider their involvement. However, as&#xD;
        the intervention is simply an additional information resource (web-site link), patients will&#xD;
        be allowed to consent during the initial consultation in clinic if they are willing to do so&#xD;
        (PPI focus group felt that such an approach is acceptable because most women are comfortable&#xD;
        with the internet and postal / phone follow up). However, as postal / phone follow up is&#xD;
        required for up to 12 weeks, they will be made aware of this and take as much time as they&#xD;
        need to consider participation.&#xD;
  &#xD;
        Women who give consent will proceed to randomisation if they are eligible to participate in&#xD;
        the trial. Consent will be recorded on the approved consent form, the original of which must&#xD;
        be retained in the site file with a copy given to the participant.&#xD;
  &#xD;
        Enrolment and Screening:&#xD;
  &#xD;
        Women with benign gynaecological conditions requiring a LH and who are suitable for a SDD are&#xD;
        eligible for inclusion. Prior to clinical consultations, the medical records of potential&#xD;
        participants may be screened for eligibility by clinic doctors, nurses, research nurses and&#xD;
        research midwives, after having received appropriate training relating to the trial. Clinic&#xD;
        doctors will confirm eligibility for the trial. The same process will be applied to patients&#xD;
        on the waiting list for SDD LH to identify eligible patients, contact them and invite them to&#xD;
        participate.&#xD;
  &#xD;
        Randomisation:&#xD;
  &#xD;
        After participant eligibility has been confirmed and informed consent has been received, the&#xD;
        participant can be randomised into the trial. Patients will be randomised in a 1:1 manner to&#xD;
        either provision of the on-line SDD LH website resource (intervention) or standard practice&#xD;
        for information provision (control). Randomisation will be performed via a web-based&#xD;
        platform. If allocated to the intervention, then the website link will be provided in&#xD;
        writing, via post, email or text (according to the patient's preference) immediately.&#xD;
        Investigators will keep their own study file log which links patients with their allocated&#xD;
        trial number in the trial Patient Recruitment and Identification Log.&#xD;
  &#xD;
        Blinding:&#xD;
  &#xD;
        Patients, clinicians, investigators, research assistants and responsible clinicians will not&#xD;
        be blinded to the assigned allocation&#xD;
  &#xD;
        Trial treatment / Intervention&#xD;
  &#xD;
        Patients with a benign condition listed for a SDD LH agreeing to participate in the study who&#xD;
        are allocated the intervention will be provided with the link to the SDD LH patient&#xD;
        information website (see Table 1 and the website https://www.mydaycasehysterectomy.com). The&#xD;
        option of this educational material will be in addition to the standard verbal and written&#xD;
        patient information provided by the BWCH. Patients allocated the control group will receive&#xD;
        standard BWCH information only.&#xD;
  &#xD;
        The decision to remove or retain cervix (total or sub-total) or remove and retain ovaries&#xD;
        will be left to the discretion of the participant in consultation with her gynaecologist. The&#xD;
        LH will be performed or supervised by a surgeon who has self-declared as having expertise in&#xD;
        laparoscopic hysterectomy and this requires the surgeon to meet minimum standards, regarding&#xD;
        experience and case-load. Satisfactory experience will require surgeons to have performed a&#xD;
        minimum of 30 cases and to have a current caseload of at least 12 cases per year&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>To evaluate the potential efficacy of additional on-line, patient education for SDD LH in achieving SDD compared to standard information giving. In addition, the utility and acceptability of patient information will be assessed as well as the impact on patient satisfaction and recovery.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Same Day Discharge following laparoscopic hysterectomy (0-23hours)</measure>
      <time_frame>0-24hours following surgery</time_frame>
      <description>This means that the patient is discharged (leaves the hospital) before midnight on the day of surgery (case notes / electronic patient record).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Satisfaction with care on discharge (bespoke patient questionnaire score)</measure>
      <time_frame>0-24hours following surgery</time_frame>
      <description>Patient satisfaction of same day discharge following laparoscopic hysterectomy (LH). protocol. This will be assessed through bespoke patient questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability and utility of patient education / information provided (score)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Patient satisfaction of acceptability and utility of patient education / information provided. This will be assessed through bespoke patient questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction with clinical outcome after laparoscopic hysterectomy (LH) (score)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Patient's satisfaction with clinical outcome after laparoscopic hysterectomy (LH) through(5-point Likert)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction with care on discharge (score)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Patient's satisfaction with care on discharge through bespoke patient questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generic quality of life post-surgery (score)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Patient's Quality of life score using EuroQol-5D-5L questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generic quality of life post-surgery (score)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Patient's Quality of life score using EuroQol-5D-5L visual analogue scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Contact with Community &amp; Clinical Care Services</measure>
      <time_frame>6 weeks</time_frame>
      <description>Serious Adverse Events through case report forms (CRF)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time from surgery to resumption of usual activities in days</measure>
      <time_frame>6-12 weeks</time_frame>
      <description>Time from surgery to resumption of usual activities using the PROMIS-SF (Patient-Reported Outcomes Measurement Information System Physical Function) questionnaire (item bank v1.2 will be used). Of the 29 items covering relevant activities for our study population, we have selected 8 items and. The selected items and the response categories were chosen by the PPI focus group to reflect the most common and generally applicable day-to-day activities. Participants will record when each activity is resumed, with full recovery being achieved once all 8 personalised activities have been resumed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to return to work (if working) in days</measure>
      <time_frame>6-12 weeks</time_frame>
      <description>This will be assessed using bespoke patient questionnaire</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Hysterectomy</condition>
    <condition>LAP</condition>
    <arm_group>
      <arm_group_label>On-line SDD LH website resource (intervention)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients allocated the experimental arm will be provided with the link to the SDD LH patient information website (https://www.mydaycasehysterectomy.com).The option of this educational material will be in addition to the standard verbal and written patient information provided by the BWCH.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard practice for information provision (control)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients allocated the control group will receive standard BWCH information only.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>On-line, multi-media information on a specifically designed website for Same Day Discharge following Laparoscopic Hysterectomy</intervention_name>
      <description>A patient educational website that provides clear, easily accessible, patient friendly information explaining what SDD after laparoscopic hysterectomy is, why SDD may be beneficial and what to expect from decision for surgery, through to the admission to hospital and immediate, short and long term recovery.</description>
      <arm_group_label>On-line SDD LH website resource (intervention)</arm_group_label>
      <arm_group_label>Standard practice for information provision (control)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Able to give informed consent to participate&#xD;
  &#xD;
            -  Have a benign gynaecological condition that is being treated with a LH&#xD;
  &#xD;
            -  Eligible to be on same day discharge pathway Patient factors&#xD;
  &#xD;
                 1. ASA I/II with no sleep apnoea. ASA III may be suitable if comorbidities are&#xD;
                    stable and optimised.&#xD;
  &#xD;
                 2. No known cardio-pulmonary compromise&#xD;
  &#xD;
                 3. No known renal disease&#xD;
  &#xD;
                 4. Age &lt;/= 60 years&#xD;
  &#xD;
                 5. BMI &lt;/=40&#xD;
  &#xD;
                 6. Not indication for admission to Gynaecological Extended Recovery Area (GERU)&#xD;
  &#xD;
            -  Surgical factors&#xD;
  &#xD;
                 1. Presumed benign disease&#xD;
  &#xD;
                 2. No anticipated surgical complications&#xD;
  &#xD;
                 3. Concomitant procedures acceptable but surgeon to decide on a case by case basis&#xD;
                    Discharge factors&#xD;
  &#xD;
                 4. Residence &lt; 1 hour from BWCH&#xD;
  &#xD;
                 5. Access to transport from hospital to home&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient above the age of 60&#xD;
  &#xD;
            -  Unwillingness or inability to comply with protocol procedures&#xD;
  &#xD;
            -  Women who require concomitant gynaecological surgery for bladder or other pelvic&#xD;
               support&#xD;
  &#xD;
            -  Women who require concomitant gynaecological surgery for excision of deep&#xD;
               endometriosis that requires dissection of the pararectal space above the age of 60&#xD;
  &#xD;
            -  Unwillingness or inability to comply with protocol procedures&#xD;
  &#xD;
            -  Women who require concomitant gynaecological surgery for bladder or other pelvic&#xD;
               support&#xD;
  &#xD;
            -  Women who require concomitant gynaecological surgery for excision of deep&#xD;
               endometriosis that requires dissection of the pararectal space&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>TJustin Clark, MD, FRCOG</last_name>
      <role>Principal Investigator</role>
      <affiliation>Birmingham Women's and Children's NHS Foundation Trust</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lina Antoun, MD, MRCOG</last_name>
      <phone>044 7518613461</phone>
      <email>lina.antoun1@nhs.net</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Paul Smith, MD, MRCOG</last_name>
      <email>paul.smith54@nhs.net</email>
    </overall_contact_backup>
    <link>
      <url>https://www.mydaycasehysterectomy.com/</url>
      <description>Related Info</description>
    </link>
    <link>
      <url>https://www.gettingitrightfirsttime.co.uk/wp-content/uploads/2020/10/National-Day-Surgery-Delivery-Pack_Sept2020_final.pdf</url>
      <description>Related Info</description>
    </link>
    <link>
      <url>http://allcatsrgrey.org.uk/wp/download/obstetrics_2/benign-gynae-indicators-report-2015-16.pdf</url>
      <description>Related Info</description>
    </link>
    <reference>
      <citation>Lonky NM, Mohan Y, Chiu VY, Park J, Kivnick S, Hong C, Hudson SM. Hysterectomy for benign conditions: Complications relative to surgical approach and other variables that lead to post-operative readmission within 90 days of surgery. Womens Health (Lond). 2017 Aug;13(2):17-26. doi: 10.1177/1745505717714657. Epub 2017 Jun 29.</citation>
      <PMID>28660800</PMID>
    </reference>
    <reference>
      <citation>Madhvani K, Curnow T, Carpenter T. Route of hysterectomy: a retrospective, cohort study in English NHS Hospitals from 2011 to 2017. BJOG. 2019 May;126(6):795-802. doi: 10.1111/1471-0528.15539. Epub 2018 Dec 30.</citation>
      <PMID>30461181</PMID>
    </reference>
    <reference>
      <citation>Moawad G, Liu E, Song C, Fu AZ. Movement to outpatient hysterectomy for benign indications in the United States, 2008-2014. PLoS One. 2017 Nov 30;12(11):e0188812. doi: 10.1371/journal.pone.0188812. eCollection 2017.</citation>
      <PMID>29190666</PMID>
    </reference>
    <reference>
      <citation>Warren L, Ladapo JA, Borah BJ, Gunnarsson CL. Open abdominal versus laparoscopic and vaginal hysterectomy: analysis of a large United States payer measuring quality and cost of care. J Minim Invasive Gynecol. 2009 Sep-Oct;16(5):581-8. doi: 10.1016/j.jmig.2009.06.018.</citation>
      <PMID>19835801</PMID>
    </reference>
    <reference>
      <citation>Bailey CR, Ahuja M, Bartholomew K, Bew S, Forbes L, Lipp A, Montgomery J, Russon K, Potparic O, Stocker M. Guidelines for day-case surgery 2019: Guidelines from the Association of Anaesthetists and the British Association of Day Surgery. Anaesthesia. 2019 Jun;74(6):778-792. doi: 10.1111/anae.14639. Epub 2019 Apr 8.</citation>
      <PMID>30963557</PMID>
    </reference>
    <reference>
      <citation>Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, MacFie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):783-800. doi: 10.1016/j.clnu.2012.08.013. Epub 2012 Sep 28.</citation>
      <PMID>23099039</PMID>
    </reference>
    <reference>
      <citation>Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.</citation>
      <PMID>19638912</PMID>
    </reference>
    <results_reference>
      <citation>Perino A, Cucinella G, Venezia R, Castelli A, Cittadini E. Total laparoscopic hysterectomy versus total abdominal hysterectomy: an assessment of the learning curve in a prospective randomized study. Hum Reprod. 1999 Dec;14(12):2996-9. doi: 10.1093/humrep/14.12.2996.</citation>
      <PMID>10601085</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Same day discharge</keyword>
    <keyword>Laparoscopic hysterectomy</keyword>
    <keyword>Educational platform</keyword>
    <keyword>Enhanced recovery</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>IPD will only be shared as part of results in a peer reviewed publication. No specific or individual participant data will be shared</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06011538
  org study id: BirminghamWCNHSFT
  nct id: NCT06011538
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Objectives: To evaluate the potential utility and efficacy of additional on-line, patient
        education resource for same day discharge following laparoscopic hysterectomy (SDD LH)
        compared to standard information resources alone
  
        Trial Design: A pilot, parallel, open, single centre, randomised controlled trial
  
        Participant Population and Sample Size: 40 women undergoing SDD LH for a benign reason
  
        Eligibility Criteria: Women with gynaecological conditions requiring a laparoscopic
        hysterectomy (LH) and who are suitable for same day discharge (SDD).
  
        Interventions: An online patient education website resource and the comparator is standard
        practice for provision of patient information (written and verbal).
  
        Outcome Measures:
  
        Primary
  
          -  Compliance with SDD Secondary
  
          -  In Hospital:
  
             o Surgical details / complexity / intraoperative and post-operative serious adverse
             events (SAEs) according to the Clavien-Dindo system grade II-IV which is a widely used
             index for the classification of surgical complications [case notes and electronic
             patient record], and time to discharge
  
          -  6 weeks:
  
               -  Satisfaction, acceptability and utility of patient education / information provided
                  (bespoke patient questionnaire; Likert scales)
  
               -  Satisfaction with care after LH (6-point Likert)
  
               -  Generic quality of life at 6 weeks post-surgery (EuroQol-5D-5L and VAS);
  
               -  Contact with Community & Clinical Care Services i.e. outpatients or emergency
                  visits, re-presentations / re-admissions to hospital (Case report form [CRF], case
                  notes, electronic patient record)
  
               -  Serious Adverse Events (CRF, case notes, electronic patient record)
  
               -  Time from surgery to resumption of usual activities using the PROMIS-SF
                  (Patient-Reported Outcomes Measurement Information System Physical Function)
                  questionnaire (Modified items / response categories)
  
          -  12 weeks:
  
               -  Time from surgery to resumption of usual activities using the PROMIS-SF
                  (Patient-Reported Outcomes Measurement Information System Physical Function)
                  questionnaire (Modified items / response categories) Time to return to work (if
                  working)
  Aim:
  
        To evaluate the potential efficacy of additional on-line, patient education for SDD LH in
        achieving SDD compared to standard information giving. In addition, the utility and
        acceptability of patient information will be assessed as well as the impact on patient
        satisfaction and recovery.
  
        Objectives:
  
        The investigators aim to assess various aspects of trial management and design. In order to
        achieve this, the objectives of the pilot randomised controlled trial (RCT) will be split
        into:
  
          -  Process Objectives
  
               -  To determine the proportion of eligible women that are screened and meet the
                  inclusion criteria
  
               -  To determine the proportion of eligible women that agree to be randomised
  
               -  To determine the robustness of proposed data collection tools; completion and
                  return rates
  
          -  Clinical Objectives
  
               -  To determine the appropriateness of the outcome measures
  
               -  To derive clinical data to help inform the sample size for a future substantive
                  study (the potential efficacy of additional on-line, patient education for SDD LH
                  in achieving SDD compared to standard information giving).
  
        Trial design and setting
  
        Trial design:
  
        A pilot, parallel, open, single centre, randomised controlled trial.
  
        Trial Setting:
  
        Recruitment to the Web-based Versus Standard Information for Same Day Hysterectomy (WISH)
        study will take place in gynaecology departments (general and relevant specialist clinics
        including menstrual disorders and pelvic pain clinics, hysteroscopy and colposcopy services)
        in an NHS, University-affiliated Teaching Hospital (Birmingham Women's & Children's Hospital
        (BWCH) in the UK.
  
        Identification of participants:
  
        Eligible women will be identified by a member of the clinical team responsible for the direct
        care of the potential participant in outpatient gynaecology clinics and pre-operative
        assessment clinics in each recruiting centre. Additionally, patients already on the waiting
        list for SDD LH will be identified and invited to participate. The study will be introduced
        by a member of the clinical or research team, with full counselling about the trial. The
        potential participant will be advised that participation in the study is entirely voluntary
        with the option of withdrawing from the study at any stage. It will be made clear that
        participation or non-participation will not affect their usual care.
  
        Assessment of Risk:
  
        SDD LH is routinely practiced at the BWCH. Verbal and written, paper-based information is
        provided. This study provides additional, on-line, multi-media information on a specifically
        designed website for SDD LH. Thus, this trial is categorised as: Type A = No higher than the
        risk of standard medical care.
  
        Eligibility
  
        Women are eligible for recruitment if they meet the inclusion criteria and do not have any of
        the exclusion criteria set out below:
  
        Inclusion Criteria:
  
          -  Able to give informed consent to participate
  
          -  Have a benign gynaecological condition that is being treated with a LH
  
          -  Eligible to be on same day discharge pathway Patient factors
  
               -  American Society of Anesthesiologists (ASA) physical status classification I/II
                  with no sleep apnoea. ASA III may be suitable if comorbidities are stable and
                  optimised.
  
               -  No known cardio-pulmonary compromise
  
               -  No known renal disease
  
               -  Age </=60 years
  
               -  BMI </=40
  
               -  Not indication for admission to Gynaecological Extended Recovery Area (GERU)
                  Surgical factors
  
               -  Presumed benign disease
  
               -  No anticipated surgical complications
  
               -  Concomitant procedures acceptable but surgeon to decide on a case by case basis
                  Discharge factors
  
               -  Residence < 1 hour from BWCH
  
               -  Access to transport from hospital to home
  
        Exclusion Criteria:
  
          -  Patient above the age of 60
  
          -  Unwillingness or inability to comply with protocol procedures
  
          -  Women who require concomitant gynaecological surgery for bladder or other pelvic support
  
          -  Women who require concomitant gynaecological surgery for excision of deep endometriosis
             that requires dissection of the pararectal space
  
        Consent
  
        It will be the responsibility of the Investigator to obtain informed consent for each
        participant prior to performing any trial related procedure. A research nurse, research
        midwife or clinician is able to take consent providing that local practice allows this and
        responsibility has been delegated by the Principal Investigator as captured on the Site
        Signature and Delegation Log.
  
        A Participant Information Sheet (PIS) will be provided to facilitate this process either at
        the time of initial consultation / hospital visit or sent through the post, via email, or by
        text as an attachment. Investigators or their delegate(s) will ensure that they adequately
        explain the aim, trial treatment, anticipated benefits and potential hazards of taking part
        in the trial to the participant. They will also stress that participation is voluntary and
        that the participant is free to decline to take part and may withdraw from the trial at any
        time. The participant will be given sufficient time to read the PIS and to discuss their
        participation with others outside of the site research team. The participant will be given
        the opportunity to ask questions. Where direct access to patient medical records is required
        the participant will give explicit consent for the regulatory authorities, members of the
        research team and or representatives of the sponsor to be given direct access to their
        medical records.
  
        The Investigator or their delegate will then countersign and date the informed consent form
        (ICF). A copy of the ICF will be given to the participant (hard copy), a copy will be filed
        in the medical notes, and the original placed in the Investigator Site File (ISF). Once the
        participant is entered into the trial, the participant's trial number will be entered on the
        ICF maintained in the ISF.
  
        Details of the informed consent discussions will be recorded in the participant's medical
        notes. This will include date of discussion, the name of the trial, summary of discussion,
        version number of the PIS given to participant and version number of ICF signed and date
        consent received. Where consent is obtained on the same day that the trial related
        assessments are due to start, a note should be made in the medical notes as to what time the
        consent was obtained and what time the procedures started.
  
        Throughout the trial the participant will have the opportunity to ask questions about the
        trial. Any new information that may be relevant to the participant's continued participation
        will be provided. Where new information becomes available which may affect the participants'
        decision to continue, participants will be given time to consider and if happy to continue
        will be re-consented. Re-consent will be documented in the medical notes. The participant's
        right to withdraw from the trial at any time will remain.
  
        Details of all patients approached about the trial will be recorded on the Participant
        Screening/Enrolment Log.
  
        Recruitment, enrolment and randomisation
  
        Recruitment:
  
        Potential participants will be identified and approached by medical staff who are responsible
        for the direct care of the potential participant after having received appropriate training
        relating to the trial and who are delegated this task on the site delegation log. Recruitment
        will take place in gynaecology clinics in gynaecologist lead centres located across the
        United Kingdom.
  
        The participant eligibility pathway to recruitment and randomisation is illustrated by the
        trial schema. Eligibility will be confirmed following discussions with the woman and a review
        of her medical notes by staff delegated this duty by the local principle investigator (PI).
  
        Potential participants will be advised that taking part in the study is entirely voluntary
        and they may withdraw from the study at any stage without this affecting their usual care.
        Potential participants will be provided with a research ethics committee (REC) approved Study
        Participant Information Sheet (PIS) and given time to consider their involvement. However, as
        the intervention is simply an additional information resource (web-site link), patients will
        be allowed to consent during the initial consultation in clinic if they are willing to do so
        (PPI focus group felt that such an approach is acceptable because most women are comfortable
        with the internet and postal / phone follow up). However, as postal / phone follow up is
        required for up to 12 weeks, they will be made aware of this and take as much time as they
        need to consider participation.
  
        Women who give consent will proceed to randomisation if they are eligible to participate in
        the trial. Consent will be recorded on the approved consent form, the original of which must
        be retained in the site file with a copy given to the participant.
  
        Enrolment and Screening:
  
        Women with benign gynaecological conditions requiring a LH and who are suitable for a SDD are
        eligible for inclusion. Prior to clinical consultations, the medical records of potential
        participants may be screened for eligibility by clinic doctors, nurses, research nurses and
        research midwives, after having received appropriate training relating to the trial. Clinic
        doctors will confirm eligibility for the trial. The same process will be applied to patients
        on the waiting list for SDD LH to identify eligible patients, contact them and invite them to
        participate.
  
        Randomisation:
  
        After participant eligibility has been confirmed and informed consent has been received, the
        participant can be randomised into the trial. Patients will be randomised in a 1:1 manner to
        either provision of the on-line SDD LH website resource (intervention) or standard practice
        for information provision (control). Randomisation will be performed via a web-based
        platform. If allocated to the intervention, then the website link will be provided in
        writing, via post, email or text (according to the patient's preference) immediately.
        Investigators will keep their own study file log which links patients with their allocated
        trial number in the trial Patient Recruitment and Identification Log.
  
        Blinding:
  
        Patients, clinicians, investigators, research assistants and responsible clinicians will not
        be blinded to the assigned allocation
  
        Trial treatment / Intervention
  
        Patients with a benign condition listed for a SDD LH agreeing to participate in the study who
        are allocated the intervention will be provided with the link to the SDD LH patient
        information website (see Table 1 and the website https://www.mydaycasehysterectomy.com). The
        option of this educational material will be in addition to the standard verbal and written
        patient information provided by the BWCH. Patients allocated the control group will receive
        standard BWCH information only.
  
        The decision to remove or retain cervix (total or sub-total) or remove and retain ovaries
        will be left to the discretion of the participant in consultation with her gynaecologist. The
        LH will be performed or supervised by a surgeon who has self-declared as having expertise in
        laparoscopic hysterectomy and this requires the surgeon to meet minimum standards, regarding
        experience and case-load. Satisfactory experience will require surgeons to have performed a
        minimum of 30 cases and to have a current caseload of at least 12 cases per year
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: To evaluate the potential efficacy of additional on-line, patient education for SDD LH in achieving SDD compared to standard information giving. In addition, the utility and acceptability of patient information will be assessed as well as the impact on patient satisfaction and recovery.
  primary purpose: Other
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Same Day Discharge following laparoscopic hysterectomy (0-23hours)
  time frame: 0-24hours following surgery
  description: This means that the patient is discharged (leaves the hospital) before midnight on the day of surgery (case notes / electronic patient record).
  measure: Satisfaction with care on discharge (bespoke patient questionnaire score)
  time frame: 0-24hours following surgery
  description: Patient satisfaction of same day discharge following laparoscopic hysterectomy (LH). protocol. This will be assessed through bespoke patient questionnaire.
  measure: Acceptability and utility of patient education / information provided (score)
  time frame: 6 weeks
  description: Patient satisfaction of acceptability and utility of patient education / information provided. This will be assessed through bespoke patient questionnaire.
  measure: Satisfaction with clinical outcome after laparoscopic hysterectomy (LH) (score)
  time frame: 6 weeks
  description: Patient's satisfaction with clinical outcome after laparoscopic hysterectomy (LH) through(5-point Likert)
  measure: Satisfaction with care on discharge (score)
  time frame: 6 weeks
  description: Patient's satisfaction with care on discharge through bespoke patient questionnaire
  measure: Generic quality of life post-surgery (score)
  time frame: 6 weeks
  description: Patient's Quality of life score using EuroQol-5D-5L questionnaire
  measure: Generic quality of life post-surgery (score)
  time frame: 6 weeks
  description: Patient's Quality of life score using EuroQol-5D-5L visual analogue scale
  measure: Contact with Community & Clinical Care Services
  time frame: 6 weeks
  description: Serious Adverse Events through case report forms (CRF)
  measure: Time from surgery to resumption of usual activities in days
  time frame: 6-12 weeks
  description: Time from surgery to resumption of usual activities using the PROMIS-SF (Patient-Reported Outcomes Measurement Information System Physical Function) questionnaire (item bank v1.2 will be used). Of the 29 items covering relevant activities for our study population, we have selected 8 items and. The selected items and the response categories were chosen by the PPI focus group to reflect the most common and generally applicable day-to-day activities. Participants will record when each activity is resumed, with full recovery being achieved once all 8 personalised activities have been resumed.
  measure: Time to return to work (if working) in days
  time frame: 6-12 weeks
  description: This will be assessed using bespoke patient questionnaire
  arm group label: On-line SDD LH website resource (intervention)
  arm group type: Experimental
  description: Patients allocated the experimental arm will be provided with the link to the SDD LH patient information website (https://www.mydaycasehysterectomy.com).The option of this educational material will be in addition to the standard verbal and written patient information provided by the BWCH.
  arm group label: Standard practice for information provision (control)
  arm group type: Active Comparator
  description: Patients allocated the control group will receive standard BWCH information only.
  intervention type: Other
  intervention name: On-line, multi-media information on a specifically designed website for Same Day Discharge following Laparoscopic Hysterectomy
  description: A patient educational website that provides clear, easily accessible, patient friendly information explaining what SDD after laparoscopic hysterectomy is, why SDD may be beneficial and what to expect from decision for surgery, through to the admission to hospital and immediate, short and long term recovery.
  arm group label: On-line SDD LH website resource (intervention)
  arm group label: Standard practice for information provision (control)
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: TJustin Clark, MD, FRCOG
  role: Principal Investigator
  affiliation: Birmingham Women's and Children's NHS Foundation Trust
  last name: Lina Antoun, MD, MRCOG
  phone: 044 7518613461
  email: lina.antoun1@nhs.net
  last name: Paul Smith, MD, MRCOG
  email: paul.smith54@nhs.net
  url: https://www.mydaycasehysterectomy.com/
  description: Related Info
  url: https://www.gettingitrightfirsttime.co.uk/wp-content/uploads/2020/10/National-Day-Surgery-Delivery-Pack_Sept2020_final.pdf
  description: Related Info
  url: http://allcatsrgrey.org.uk/wp/download/obstetrics_2/benign-gynae-indicators-report-2015-16.pdf
  description: Related Info
  citation: Lonky NM, Mohan Y, Chiu VY, Park J, Kivnick S, Hong C, Hudson SM. Hysterectomy for benign conditions: Complications relative to surgical approach and other variables that lead to post-operative readmission within 90 days of surgery. Womens Health (Lond). 2017 Aug;13(2):17-26. doi: 10.1177/1745505717714657. Epub 2017 Jun 29.
  PMID: 28660800
  citation: Madhvani K, Curnow T, Carpenter T. Route of hysterectomy: a retrospective, cohort study in English NHS Hospitals from 2011 to 2017. BJOG. 2019 May;126(6):795-802. doi: 10.1111/1471-0528.15539. Epub 2018 Dec 30.
  PMID: 30461181
  citation: Moawad G, Liu E, Song C, Fu AZ. Movement to outpatient hysterectomy for benign indications in the United States, 2008-2014. PLoS One. 2017 Nov 30;12(11):e0188812. doi: 10.1371/journal.pone.0188812. eCollection 2017.
  PMID: 29190666
  citation: Warren L, Ladapo JA, Borah BJ, Gunnarsson CL. Open abdominal versus laparoscopic and vaginal hysterectomy: analysis of a large United States payer measuring quality and cost of care. J Minim Invasive Gynecol. 2009 Sep-Oct;16(5):581-8. doi: 10.1016/j.jmig.2009.06.018.
  PMID: 19835801
  citation: Bailey CR, Ahuja M, Bartholomew K, Bew S, Forbes L, Lipp A, Montgomery J, Russon K, Potparic O, Stocker M. Guidelines for day-case surgery 2019: Guidelines from the Association of Anaesthetists and the British Association of Day Surgery. Anaesthesia. 2019 Jun;74(6):778-792. doi: 10.1111/anae.14639. Epub 2019 Apr 8.
  PMID: 30963557
  citation: Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, MacFie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):783-800. doi: 10.1016/j.clnu.2012.08.013. Epub 2012 Sep 28.
  PMID: 23099039
  citation: Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
  PMID: 19638912
  citation: Perino A, Cucinella G, Venezia R, Castelli A, Cittadini E. Total laparoscopic hysterectomy versus total abdominal hysterectomy: an assessment of the learning curve in a prospective randomized study. Hum Reprod. 1999 Dec;14(12):2996-9. doi: 10.1093/humrep/14.12.2996.
  PMID: 10601085
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: IPD will only be shared as part of results in a peer reviewed publication. No specific or individual participant data will be shared