<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/NCT03290521</url>
  </required_header>
  <id_info>
    <org_study_id>PAINLESS2812</org_study_id>
    <nct_id>NCT03290521</nct_id>
  </id_info>
  <brief_title>Intraperitoneal Lavage for Reducing Pain in Laparoscopy</brief_title>
  <official_title>The Role of Intraperitoneal Irrigation and Lavage With Normal Saline for Reduction of Postoperative Pain After Laparoscopic Hysterectomy and Myomectomy: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Campus Bio-Medico University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Campus Bio-Medico University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of the present study is to evaluate the role of intraperitoneal washing irrigation&#xD;
      with saline solution at the end of laparoscopic hysterectomy or myomectomy in reducing&#xD;
      perception of postoperative pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be fully and accurately informed on the type of intervention and will sign a&#xD;
      specific informed consent, in accordance with CBM standards, both for the intervention to&#xD;
      which the patient will undergo both for the study in question.&#xD;
&#xD;
      Randomization will be performed through a randomized randomization table generated by a&#xD;
      computer. Patients will therefore be divided into two groups:&#xD;
&#xD;
      A - Yes Washing (SL) B - No Washing (NL) Prior to surgery, hemoglobin and PCR values will be&#xD;
      evaluated in the preoperative.&#xD;
&#xD;
      Prior to the incision, an antibiotic prophylaxis will be performed with cefazoline 2gr&#xD;
      intravenously.&#xD;
&#xD;
      The intervention in both groups involves the periombelic cutaneous incision and the&#xD;
      sub-umbilical band. Introduction of 10mm led trocar based on open technique. The introduction&#xD;
      of optics and CO2 insufflation allows the macroscopic visualization of the endotominal&#xD;
      organs. The investigators proceed with the introduction of 3 additional 3-lane trocar&#xD;
      accessories in the left iliac fossa, right and overlaid iliac thorax. You will perform a&#xD;
      hysterectomy possibly associated with annessiectomy or myomectomy according to the surgical&#xD;
      indication. Careful hemostasis is carried out. In the SL group, the washing process is&#xD;
      continued. In particular, 1000cc of laced ringer is instilled by changing the position of the&#xD;
      patient in Trendelenburg and Anti-Trendelenburg so that the liquid contacts not only the&#xD;
      internal surgical wounds but the whole wall of the abdominal cavity. The surgery ends with&#xD;
      the closure of the band and the breasts cutaneous. The parameters measured during the&#xD;
      operation are: operating time, amount of CO2 injected (L), pneumoperitoneal pressure (mmHg).&#xD;
      The operator surgeon is always the same.&#xD;
&#xD;
      In the postoperative period, the following parameters will be evaluated: hemoglobin, white&#xD;
      blood cells, PCR, body temperature, recovery of intestinal activity, administration of&#xD;
      toradol, paracetamol and possible morphine and postoperative postoperative pain, palpation,&#xD;
      cough. The latter is evaluated through tables using the VAS visual scale: patients report the&#xD;
      subjective characteristics of perceived postoperative pain by attributing a value of 0 (no&#xD;
      pain) to 10 (worse pain than I can imagine). It assesses the occurrence of any complications&#xD;
      in post-operative, infection and fever, which may require the patient's exclusion from the&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 30, 2019</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>Patients will therefore be divided into two groups:&#xD;
A - Yes Washing (SL) B - No Washing (NL)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain</measure>
    <time_frame>17 months</time_frame>
    <description>to evaluate the postoperative pain using VAS scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>infections</measure>
    <time_frame>17 months</time_frame>
    <description>postoperative infections</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">277</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>A - Yes Washing (SL)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, the washing process is continued. In particular, 1000cc of laced ringer is instilled by changing the position of the patient in Trendelenburg and Anti-Trendelenburg so that the liquid contacts not only the internal surgical wounds but the whole wall of the abdominal cavity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B- No Washing (NL)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>No washing was performed before the end of surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>intraperitoneal washing with saline solution</intervention_name>
    <description>intraperitoneal washing at the end of surgery</description>
    <arm_group_label>A - Yes Washing (SL)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No washing</intervention_name>
    <description>no washing</description>
    <arm_group_label>B- No Washing (NL)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients candidates tor hysterectomy, hysterectomy and annessiectomy, laparoscopic&#xD;
             myomectomy;&#xD;
&#xD;
          -  ECOG Performance Status between 0 and 1;&#xD;
&#xD;
          -  ages between 18 and 70 years&#xD;
&#xD;
          -  no present or previous systemic neoplastic disease&#xD;
&#xD;
          -  signed informed consent to the operation and execution of the intraperitoneal wash&#xD;
             procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  pre-existing coagulopathy, neurological or cognitive dysfunction,&#xD;
&#xD;
          -  previous or recent pelvic flogosis,&#xD;
&#xD;
          -  previous opioid intake for chronic pain,&#xD;
&#xD;
          -  previous abdominal surgery,&#xD;
&#xD;
          -  previous or current systemic neoplastic disease&#xD;
&#xD;
          -  concomitant ovarian and cervical gynecological disease,&#xD;
&#xD;
          -  intraoperative conversion from laparoscopy to laparotomy ,&#xD;
&#xD;
          -  intraoperative complications,&#xD;
&#xD;
          -  use of morphine in the postoperative period,&#xD;
&#xD;
          -  ECOG Performance Status &gt;1.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roberto Angioli</last_name>
    <role>Principal Investigator</role>
    <affiliation>Campus Bio-Medico University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ethics Committee</name>
      <address>
        <city>Rome</city>
        <zip>00128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>December 17, 2021</last_update_submitted>
  <last_update_submitted_qc>December 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Campus Bio-Medico University</investigator_affiliation>
    <investigator_full_name>Roberto Angioli</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>pain</keyword>
  <keyword>laparoscopy</keyword>
  <keyword>washing</keyword>
  <keyword>intraperitoneal irrigation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Use of intraperitoneal washing to reduce postoperative pain in laparoscopy</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03290521
org study id: PAINLESS2812
nct id: NCT03290521
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the present study is to evaluate the role of intraperitoneal washing irrigation
      with saline solution at the end of laparoscopic hysterectomy or myomectomy in reducing
      perception of postoperative pain.
Patients will be fully and accurately informed on the type of intervention and will sign a
      specific informed consent, in accordance with CBM standards, both for the intervention to
      which the patient will undergo both for the study in question.

      Randomization will be performed through a randomized randomization table generated by a
      computer. Patients will therefore be divided into two groups:

      A - Yes Washing (SL) B - No Washing (NL) Prior to surgery, hemoglobin and PCR values will be
      evaluated in the preoperative.

      Prior to the incision, an antibiotic prophylaxis will be performed with cefazoline 2gr
      intravenously.

      The intervention in both groups involves the periombelic cutaneous incision and the
      sub-umbilical band. Introduction of 10mm led trocar based on open technique. The introduction
      of optics and CO2 insufflation allows the macroscopic visualization of the endotominal
      organs. The investigators proceed with the introduction of 3 additional 3-lane trocar
      accessories in the left iliac fossa, right and overlaid iliac thorax. You will perform a
      hysterectomy possibly associated with annessiectomy or myomectomy according to the surgical
      indication. Careful hemostasis is carried out. In the SL group, the washing process is
      continued. In particular, 1000cc of laced ringer is instilled by changing the position of the
      patient in Trendelenburg and Anti-Trendelenburg so that the liquid contacts not only the
      internal surgical wounds but the whole wall of the abdominal cavity. The surgery ends with
      the closure of the band and the breasts cutaneous. The parameters measured during the
      operation are: operating time, amount of CO2 injected (L), pneumoperitoneal pressure (mmHg).
      The operator surgeon is always the same.

      In the postoperative period, the following parameters will be evaluated: hemoglobin, white
      blood cells, PCR, body temperature, recovery of intestinal activity, administration of
      toradol, paracetamol and possible morphine and postoperative postoperative pain, palpation,
      cough. The latter is evaluated through tables using the VAS visual scale: patients report the
      subjective characteristics of perceived postoperative pain by attributing a value of 0 (no
      pain) to 10 (worse pain than I can imagine). It assesses the occurrence of any complications
      in post-operative, infection and fever, which may require the patient's exclusion from the
      study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will therefore be divided into two groups:
A - Yes Washing (SL) B - No Washing (NL)
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: pain
time frame: 17 months
description: to evaluate the postoperative pain using VAS scale
measure: infections
time frame: 17 months
description: postoperative infections
arm group label: A - Yes Washing (SL)
arm group type: Experimental
description: In this group, the washing process is continued. In particular, 1000cc of laced ringer is instilled by changing the position of the patient in Trendelenburg and Anti-Trendelenburg so that the liquid contacts not only the internal surgical wounds but the whole wall of the abdominal cavity.
arm group label: B- No Washing (NL)
arm group type: Experimental
description: No washing was performed before the end of surgery
intervention type: Procedure
intervention name: intraperitoneal washing with saline solution
description: intraperitoneal washing at the end of surgery
arm group label: A - Yes Washing (SL)
intervention type: Procedure
intervention name: No washing
description: no washing
arm group label: B- No Washing (NL)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Roberto Angioli
role: Principal Investigator
affiliation: Campus Bio-Medico University
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Campus Bio-Medico University
investigator full name: Roberto Angioli
investigator title: Director
mesh term: Pain, Postoperative
sharing ipd: No
ipd description: Use of intraperitoneal washing to reduce postoperative pain in laparoscopy