<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/NCT04461275</url>
  </required_header>
  <id_info>
    <org_study_id>Z20202017</org_study_id>
    <nct_id>NCT04461275</nct_id>
  </id_info>
  <brief_title>CHASE : aCcelerated 23-Hour erAS Care for Colorectal Surgery</brief_title>
  <acronym>CHASE</acronym>
  <official_title>ERAS 2.0 - Accelerated 23-hour ERAS Care for Colorectal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zuyderland Medisch Centrum</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zuyderland Medisch Centrum</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>
      Rationale: Throughout the years, there has been a rapid change in the perioperative protocols&#xD;
      and procedures surrounding colorectal surgery. Upon the introduction of the Enhanced Recovery&#xD;
      After Surgery (ERAS) program in Western countries, an improvement in postoperative outcomes&#xD;
      was seen. Nowadays, researchers focus on further improving the current standard ERAS programs&#xD;
      enabling an accelerated version hereof.&#xD;
&#xD;
      Objective: The aim of this study is to investigate the feasibility and safety of a 23-hour&#xD;
      accelerated ERAS protocol (ERAS 2.0) for patients undergoing colorectal surgery compared to a&#xD;
      retrospective cohort of patients who followed ERAS 1.0 for colorectal surgery. In this ERAS&#xD;
      2.0 protocol, patients undergoing colorectal surgery will be discharged within 23 hours after&#xD;
      surgery.&#xD;
&#xD;
      Study design: This study is an investigator-initiated, single-center prospective study.&#xD;
&#xD;
      Study population: Patients aged ≥ 18 years ≤ 80 undergoing surgical resection for colorectal&#xD;
      pathology that meet the eligibility criteria will be invited to participate in this study.&#xD;
&#xD;
      Intervention: Adhering to a strict multidisciplinary and multifaceted ERAS 2.0 protocol,&#xD;
      patients receiving elective colorectal surgery will be discharged 23-hours after surgery.&#xD;
&#xD;
      Main study parameters/endpoints: Rate of the successful and safe application of the 23-hour&#xD;
      accelerated ERAS 2.0 protocol for patients undergoing elective colorectal surgery. Success&#xD;
      rate will be measured in readmission rate and safety will be measured with rate of serious&#xD;
      adverse events (Clavien Dindo ≥3b). Success rate (feasibility) will also be measured in&#xD;
      percentage of patients who were not able to be discharged 23 hours after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to investigate the feasibility and safety of a 23-hour accelerated&#xD;
      ERAS 2.0 protocol for patients undergoing colorectal surgery compared to a retrospective&#xD;
      cohort of patients who followed ERAS 1.0 for colorectal surgery. In this ERAS 2.0 protocol,&#xD;
      patients undergoing colorectal surgery will be discharged within 23 hours after surgery.&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
      To assess the successful and safe application of the 23-hour accelerated ERAS 2.0 protocol&#xD;
      for patients undergoing colorectal surgery.&#xD;
&#xD;
      Secondary Objective(s):&#xD;
&#xD;
        -  Postoperative outcomes, including morbidity and mortality within 30 days;&#xD;
&#xD;
        -  Patient experience and satisfaction.&#xD;
&#xD;
      This study is an investigator-initiated, single-center prospective feasibility study. This&#xD;
      feasibility study will compare 30 consecutive patients following the ERAS 2.0 program to 30&#xD;
      patients of a retrospective cohort who followed the current standard ERAS 1.0 protocol in&#xD;
      Zuyderland Medical Center.&#xD;
&#xD;
      Population:&#xD;
&#xD;
      Patients diagnosed with malignant colorectal disease which requires surgical resection that&#xD;
      meets the eligibility criteria will be invited to participate in this feasibility study.&#xD;
      Patients will be approached on the surgical outpatient clinic at both locations from&#xD;
      Zuyderland Medical Center. The study and actual surgery will take place only at location&#xD;
      Sittard-Geleen.&#xD;
&#xD;
      Screening:&#xD;
&#xD;
      After written informed consent is obtained, participants are screened for further&#xD;
      suitability. All participants will undergo a brief physical screening performed by an&#xD;
      anesthesiologist. This screening will include: a complete cardiopulmonary physical&#xD;
      examination, rest-EKG and routine laboratory workup. Should any contraindications be found&#xD;
      during this screening, this will be used to further exclude patients from this study. In&#xD;
      addition, participants are given extra information about ERAS 2.0 and expectations will be&#xD;
      managed by discussing common side-effects and symptoms after general anesthesia and&#xD;
      laparoscopic colorectal surgery.Only participants scheduled to undergo left-sided colorectal&#xD;
      surgery are given a prescription for Bisacodyl 5mg as bowel preparation. Patients will be&#xD;
      instructed to take 2 tablets the night before surgery and one tablet the morning of the&#xD;
      surgery. Non-diabetic participants will be provided with 2 preoperative carbohydrate drinks&#xD;
      (PreOp).&#xD;
&#xD;
      6.2.2 Preoperative Surgical ward On the day of surgery, participants are admitted early on&#xD;
      the surgical ward and are prepared for surgery. They are required to present themselves at&#xD;
      the surgical ward two hours prior to surgery. Participants will then be instructed to take&#xD;
      the second preoperative carbohydrate drink (PreOp). Diabetic participants will not be&#xD;
      provided with PreOp. As part of ERAS 2.0, it will be required of the participants to walk to&#xD;
      the Holding with their bed with the assistance of their nurse.&#xD;
&#xD;
      Pre Anesthesia Care Unit (PACU) While participants are being prepared for anesthesia and&#xD;
      surgery, they will once more be informed about the possible side-effects and discomfort&#xD;
      associated with anesthesia and abdominal surgery. This in an effort to further manage&#xD;
      expectations.&#xD;
&#xD;
      Preoperative administration of multimodal analgesia regimen is initiated in the PACU. This&#xD;
      will consist of 1 gram Paracetamol and 600 milligrams Gabapentin (300 mg if GFR &lt;60 ml/min or&#xD;
      age&gt; 70 years) intravenously.&#xD;
&#xD;
      Perioperative Participants are brought to the operating theater and the &quot;time-out&quot; check will&#xD;
      be done. Here after the participant is prepared for anesthesia and surgery. Standard&#xD;
      monitoring according to ASA guidelines will be applied.&#xD;
&#xD;
      Anesthesia Pre-induction: Spinal anesthesia consisting of 12.5 mg Bupivacaine combined with&#xD;
      intrathecal morphine 300 mcg will be administered intravenously.&#xD;
&#xD;
      Induction: 1-2 mg per kg Propofol 2% plus TIVA (a mix of 50ml propofol plus 2% 500mcg Ultiva)&#xD;
      at 4mcg/ml. In addition a bolus of Ketanest-S will be administered at 0.25 mg/kg. Dosages are&#xD;
      adjusted to age and weight of the participant.&#xD;
&#xD;
      Fluid therapy: only balanced crystalloids are chosen for intravenous fluids (Ringer Lactate&#xD;
      or Stereofundin). Optimization of fluid therapy is achieved by guided Esophageal Doppler or&#xD;
      Flo Trac System management up until the end of surgery. Continuous perfusion of Ringer&#xD;
      Lactate / Stereofundin will be set at 3 ml/kg/hour IV.&#xD;
&#xD;
      Ventilation: Optimal ventilation parameters will be obtained during surgery with: Total&#xD;
      Volume 6-8 ml/kg; minimum FiO2 to prevent atelectasis and optimal PEEP (patients specific) to&#xD;
      prevent peri- and postoperative atelectasis.&#xD;
&#xD;
      Surgery - peroperative All participants will be operated on laparoscopically, in a true&#xD;
      minimally invasive manner. With exception of the following two factors pertaining to ERAS&#xD;
      2.0, all operations will be performed according to standard hospital protocols. (1) Starting&#xD;
      intra-abdominal pressure will be set at 12 mmHg. During surgery, the intra-abdominal pressure&#xD;
      will be gradually reduced to an end pressure of 8 mmHg. This method has been proven to be&#xD;
      safe and is associated with less postoperative pain caused by laparoscopic insufflation. (2)&#xD;
      Primary anastomosis will be performed intracorporeally as this method is associated with&#xD;
      similar results to extracorporeal anastomosis. No additional mini-laparotomy will be&#xD;
      performed. The specimen will be extracted through a suprapubic pfannenstiel incision. After&#xD;
      surgery, routine postoperative measures will be used to omit sedation and commence recovery.&#xD;
      If surgery was uncomplicated and performed under 2 hours, the urinary catheter will be&#xD;
      removed in the operation theater.&#xD;
&#xD;
      Postoperative Recovery ward After surgery, participants are brought to the recovery ward&#xD;
      where further care will be given before transporting them to the surgical ward. Here&#xD;
      participants are continuously monitored and checked for postoperative nausea, pain and&#xD;
      discomfort. In case of nausea and/or vomiting, participants are treated according to standard&#xD;
      hospital protocols. To bridge postoperative pain management, participants will receive 7.5mg&#xD;
      Meloxicam postoperatively. Postoperative pain management consists of 1000mg Paracetamol IV&#xD;
      every 6 hours. If necessary, 5-20mg Oxynorm (tablet) can be offered up to 6 times a day. To&#xD;
      stimulate intake and gastrointestinal motility, patients are offered a popsicle on the&#xD;
      recovery ward.&#xD;
&#xD;
      Surgical ward&#xD;
&#xD;
      Postoperative day 0:&#xD;
&#xD;
      Upon arrival on the surgical ward, postoperative care is resumed according to standard&#xD;
      hospital protocol with respect to anti-emetic care, patient monitoring and&#xD;
      thromboprophylaxis. Routine physical examination and evaluation will take place.&#xD;
&#xD;
      The postoperative care-points of ERAS 2.0 are: Minimal-opiate pain management; early removal&#xD;
      of the urinary catheter, early oral intake; early stop of IV-fluids and early mobilization.&#xD;
      Pain management is achieved with Paracetamol and Meloxicam, and if needed Oxynorm. Standard&#xD;
      hospital dosages will be used. At 22:00 hours, if still in situ, urinary catheters will be&#xD;
      removed. Intake is stimulated and participants will be offered food and beverages, starting&#xD;
      with fluids gradually increasing to full oral intake tolerance of their normal diet.&#xD;
      Participants are encouraged to sit up straight in bed as much as possible and to mobilize in&#xD;
      their room.&#xD;
&#xD;
      Postoperative day 1:&#xD;
&#xD;
      The following day, participants will be evaluated for measure of recovery and suitability for&#xD;
      discharge. Routine physical examination and evaluation will take place. The surgical incision&#xD;
      sites will be evaluated and the abdomen will be examined for swelling, redness and for&#xD;
      possible hematoma/bleeds. Participants will be evaluated for pain using the VAS pain score&#xD;
      and will be evaluated for other signs of discomfort.&#xD;
&#xD;
      Participants are considered as ' functionally recovered' and safe for discharge if the&#xD;
      following criteria are met:&#xD;
&#xD;
        -  Pain under control with oral analgesics (VAS &lt;4)&#xD;
&#xD;
        -  No symptoms of nausea and/or vomiting&#xD;
&#xD;
        -  Flatus or passing of stools&#xD;
&#xD;
        -  Oral intake possible (resumed full diet)&#xD;
&#xD;
        -  Spontaneous micturition&#xD;
&#xD;
        -  Able to mobilize independently&#xD;
&#xD;
        -  No alarm signs present (fever, tachycardia, hypotension, dyspnea or somnolence).&#xD;
&#xD;
      Participants are only discharged if they tick off all the requirements on the discharge&#xD;
      checklist. Before discharge, their nurse will explain the recovery trajectory after&#xD;
      discharge, including the telephonic aftercare. This includes pain management, dietary and&#xD;
      mobilizing advice, thromboprophylaxis instructions and alarm symptoms to be weary of.&#xD;
      Participants will receive a discharge folder with all necessary information, including all&#xD;
      available contact numbers. The abovementioned information will be included in the discharge&#xD;
      letter that patients receive upon leaving the surgical ward.&#xD;
&#xD;
      Care after discharge Telephonic aftercare On the evening of the day of discharge,&#xD;
      participants will be contacted by the attending nurse. A premade ERAS 2.0 checklist&#xD;
      concerning recovery and possible alarm symptoms will be used to assess recovery. On&#xD;
      postoperative day 4, participants will be contacted again via telephone by the attending&#xD;
      nurse practitioner, and the same steps are repeated.&#xD;
&#xD;
      Outpatient clinic Participants are given an appointment with a colorectal surgeon to be&#xD;
      checked at the surgical outpatient clinic. During this appointment, the overall experience of&#xD;
      the participant will be evaluated, together with his/her clinical recovery. The participant&#xD;
      will be provided with an evaluation form.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2020</start_date>
  <completion_date type="Actual">September 30, 2021</completion_date>
  <primary_completion_date type="Actual">August 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This study is an investigator-initiated, single-center prospective feasibility study. This feasibility study will compare 30 consecutive patients following the ERAS 2.0 program to 30 patients of a retrospective cohort who followed the current standard ERAS 1.0 protocol.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of the successful and safe application of the 23-hour accelerated ERAS 2.0 protocol for patients undergoing elective colorectal surgery.</measure>
    <time_frame>30 days</time_frame>
    <description>Success rate (feasibility) will be measured in readmission rate and safety will be measured with rate of serious adverse events (Clavien Dindo ≥3b).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>• Number of Participants who develop Postoperative Complications within 30 days</measure>
    <time_frame>30 day</time_frame>
    <description>• Number of Participants who develop Postoperative Complications within 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Number of Participants with Postoperative Mortality within 30 days</measure>
    <time_frame>30 days</time_frame>
    <description>• Number of Participants with Postoperative Mortality within 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Patient satisfaction evaluation by means of a questionnaire to evaluate the patients subjective experience during the duration of this study.</measure>
    <time_frame>10 days</time_frame>
    <description>• Patient satisfaction evaluation questionnaire to evaluate the patients subjective experience during the duration of this study and their subjective experience with the ERAS 2.0 protocol. In this questionnaire, patients will be asked to evaluate their experience based on 5 pre-set questions with a 10-point scale (1 being very bad and 10 being very good).&#xD;
Were you sufficiently informed about the ERAS 2.0 protocol?&#xD;
How did you experience the guidance provided (by nurses and doctors) within this protocol?&#xD;
Was the care provided after hospital discharge satisfactory?&#xD;
Was it necessary to contact the hospital after discharge? And if yes, how often?&#xD;
What grade would you give this programme?</description>
  </secondary_outcome>
  <other_outcome>
    <measure>• Demographic parameters</measure>
    <time_frame>Upon inclusion</time_frame>
    <description>• Demographic parameters such as age, height, sex, comorbidities</description>
  </other_outcome>
  <other_outcome>
    <measure>• Disease related demographics</measure>
    <time_frame>After surgery and within 14 days after surgery</time_frame>
    <description>• Disease related demographics such as tumor type, location, type of resection, etc.</description>
  </other_outcome>
  <other_outcome>
    <measure>• Short Nutritional Assessment Questionnaire (SNAQ)</measure>
    <time_frame>Upon inclusion</time_frame>
    <description>• Short Nutritional Assessment Questionnaire (SNAQ) Lowest score: 0 and Highest score: 5&#xD;
score 0 or 1: low risk of malnutrition score 2: moderate risk of malnutrition score ≥ 3: high risk of malnutrition, refer to dietician</description>
  </other_outcome>
  <other_outcome>
    <measure>• Groningen Frailty Index (GFI)</measure>
    <time_frame>Upon inclusion</time_frame>
    <description>• Groningen Frailty Index (GFI)&#xD;
Lowest score: 0 and Highest score: 15&#xD;
score &lt;4: not frail score 4-5: frail score ≥ 6: really frail</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Enhanced Recovery After Surgery</condition>
  <arm_group>
    <arm_group_label>ERAS 2.0 group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients included in the ERAS 2.0 group will follow the ERAS 2.0 accelerated care protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ERAS 2.0</intervention_name>
    <description>ERAS 2.0 accelerated protocol with adequate fluid management, pain control and truly minimally invasive surgery (intracorporeal anastomosis)</description>
    <arm_group_label>ERAS 2.0 group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent;&#xD;
&#xD;
          -  Is ≥ 18 years ≤ 80;&#xD;
&#xD;
          -  BMI ≤ 35 kg/m2;&#xD;
&#xD;
          -  WHO performance status = 0&#xD;
&#xD;
          -  Is diagnosed with (non-complicated) colorectal cancer&#xD;
&#xD;
          -  Is scheduled to undergo elective laparoscopic colorectal surgery (ileocecal resection,&#xD;
             right or left hemicolectomy, transvers colon resection) with primary anastomosis;&#xD;
&#xD;
          -  Primary anastomosis is performed intracorporeally;&#xD;
&#xD;
          -  Uncomplicated operation;&#xD;
&#xD;
          -  Readily available ambulant care provided by an adult family member for the first 24&#xD;
             hours after discharge;&#xD;
&#xD;
          -  Patient is adequately reachable by phone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA classification ≥ 3;&#xD;
&#xD;
          -  Subjects who have limited mobility and/or need to be aided/assisted when mobilizing;&#xD;
&#xD;
          -  Subjects with a history of active pulmonary infection, any other active infection, any&#xD;
             uncontrolled medical disease&#xD;
&#xD;
          -  Subjects with a contraindication for oral NSAIDs;&#xD;
&#xD;
          -  Subjects with a contraindication for spinal anesthesia;&#xD;
&#xD;
          -  Subjects requiring parenteral nutrition prior to surgery;&#xD;
&#xD;
          -  Subjects scheduled to undergo lower rectal resections;&#xD;
&#xD;
          -  Subjects receiving an ostomy;&#xD;
&#xD;
          -  Subjects who experience complications preoperatively;&#xD;
&#xD;
          -  Subjects who are mentally incompetent, challenged or requiring aid with daily life&#xD;
             activities.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James van Bastelaar, M.D., PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>GE-, Oncologic-surgeon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zuyderland Medical Center</name>
      <address>
        <city>Sittard</city>
        <state>Limburg</state>
        <zip>6162 BG</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>Al-Mazrou AM, Chiuzan C, Kiran RP. Factors influencing discharge disposition after colectomy. Surg Endosc. 2018 Jul;32(7):3032-3040. doi: 10.1007/s00464-017-6013-z. Epub 2017 Dec 27.</citation>
    <PMID>29282575</PMID>
  </reference>
  <reference>
    <citation>Dobradin A, Ganji M, Alam SE, Kar PM. Laparoscopic colon resections with discharge less than 24 hours. JSLS. 2013 Apr-Jun;17(2):198-203. doi: 10.4293/108680813X13654754535791.</citation>
    <PMID>23925012</PMID>
  </reference>
  <reference>
    <citation>Chand M, De'Ath HD, Rasheed S, Mehta C, Bromilow J, Qureshi T. The influence of peri-operative factors for accelerated discharge following laparoscopic colorectal surgery when combined with an enhanced recovery after surgery (ERAS) pathway. Int J Surg. 2016 Jan;25:59-63. doi: 10.1016/j.ijsu.2015.11.047. Epub 2015 Nov 30.</citation>
    <PMID>26654893</PMID>
  </reference>
  <results_reference>
    <citation>Rossi G, Vaccarezza H, Vaccaro CA, Mentz RE, Im V, Alvarez A, Quintana GO. Two-day hospital stay after laparoscopic colorectal surgery under an enhanced recovery after surgery (ERAS) pathway. World J Surg. 2013 Oct;37(10):2483-9. doi: 10.1007/s00268-013-2155-x.</citation>
    <PMID>23881088</PMID>
  </results_reference>
  <results_reference>
    <citation>Emmanuel A, Chohda E, Botfield C, Ellul J. Accelerated discharge within 72 hours of colorectal cancer resection using simple discharge criteria. Ann R Coll Surg Engl. 2018 Jan;100(1):52-56. doi: 10.1308/rcsann.2017.0149. Epub 2017 Sep 15.</citation>
    <PMID>29022790</PMID>
  </results_reference>
  <results_reference>
    <citation>Levy BF, Scott MJ, Fawcett WJ, Rockall TA. 23-hour-stay laparoscopic colectomy. Dis Colon Rectum. 2009 Jul;52(7):1239-43. doi: 10.1007/DCR.0b013e3181a0b32d.</citation>
    <PMID>19571699</PMID>
  </results_reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>March 1, 2022</last_update_submitted>
  <last_update_submitted_qc>March 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colorectal Cancer</keyword>
  <keyword>Enhanced Recovery After Surgery</keyword>
  <keyword>Accelerated Care</keyword>
  <keyword>Truly Minimally Invasive Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04461275
org study id: Z20202017
nct id: NCT04461275
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Rationale: Throughout the years, there has been a rapid change in the perioperative protocols
      and procedures surrounding colorectal surgery. Upon the introduction of the Enhanced Recovery
      After Surgery (ERAS) program in Western countries, an improvement in postoperative outcomes
      was seen. Nowadays, researchers focus on further improving the current standard ERAS programs
      enabling an accelerated version hereof.

      Objective: The aim of this study is to investigate the feasibility and safety of a 23-hour
      accelerated ERAS protocol (ERAS 2.0) for patients undergoing colorectal surgery compared to a
      retrospective cohort of patients who followed ERAS 1.0 for colorectal surgery. In this ERAS
      2.0 protocol, patients undergoing colorectal surgery will be discharged within 23 hours after
      surgery.

      Study design: This study is an investigator-initiated, single-center prospective study.

      Study population: Patients aged ≥ 18 years ≤ 80 undergoing surgical resection for colorectal
      pathology that meet the eligibility criteria will be invited to participate in this study.

      Intervention: Adhering to a strict multidisciplinary and multifaceted ERAS 2.0 protocol,
      patients receiving elective colorectal surgery will be discharged 23-hours after surgery.

      Main study parameters/endpoints: Rate of the successful and safe application of the 23-hour
      accelerated ERAS 2.0 protocol for patients undergoing elective colorectal surgery. Success
      rate will be measured in readmission rate and safety will be measured with rate of serious
      adverse events (Clavien Dindo ≥3b). Success rate (feasibility) will also be measured in
      percentage of patients who were not able to be discharged 23 hours after surgery.
The aim of this study is to investigate the feasibility and safety of a 23-hour accelerated
      ERAS 2.0 protocol for patients undergoing colorectal surgery compared to a retrospective
      cohort of patients who followed ERAS 1.0 for colorectal surgery. In this ERAS 2.0 protocol,
      patients undergoing colorectal surgery will be discharged within 23 hours after surgery.

      Primary Objective:

      To assess the successful and safe application of the 23-hour accelerated ERAS 2.0 protocol
      for patients undergoing colorectal surgery.

      Secondary Objective(s):

        -  Postoperative outcomes, including morbidity and mortality within 30 days;

        -  Patient experience and satisfaction.

      This study is an investigator-initiated, single-center prospective feasibility study. This
      feasibility study will compare 30 consecutive patients following the ERAS 2.0 program to 30
      patients of a retrospective cohort who followed the current standard ERAS 1.0 protocol in
      Zuyderland Medical Center.

      Population:

      Patients diagnosed with malignant colorectal disease which requires surgical resection that
      meets the eligibility criteria will be invited to participate in this feasibility study.
      Patients will be approached on the surgical outpatient clinic at both locations from
      Zuyderland Medical Center. The study and actual surgery will take place only at location
      Sittard-Geleen.

      Screening:

      After written informed consent is obtained, participants are screened for further
      suitability. All participants will undergo a brief physical screening performed by an
      anesthesiologist. This screening will include: a complete cardiopulmonary physical
      examination, rest-EKG and routine laboratory workup. Should any contraindications be found
      during this screening, this will be used to further exclude patients from this study. In
      addition, participants are given extra information about ERAS 2.0 and expectations will be
      managed by discussing common side-effects and symptoms after general anesthesia and
      laparoscopic colorectal surgery.Only participants scheduled to undergo left-sided colorectal
      surgery are given a prescription for Bisacodyl 5mg as bowel preparation. Patients will be
      instructed to take 2 tablets the night before surgery and one tablet the morning of the
      surgery. Non-diabetic participants will be provided with 2 preoperative carbohydrate drinks
      (PreOp).

      6.2.2 Preoperative Surgical ward On the day of surgery, participants are admitted early on
      the surgical ward and are prepared for surgery. They are required to present themselves at
      the surgical ward two hours prior to surgery. Participants will then be instructed to take
      the second preoperative carbohydrate drink (PreOp). Diabetic participants will not be
      provided with PreOp. As part of ERAS 2.0, it will be required of the participants to walk to
      the Holding with their bed with the assistance of their nurse.

      Pre Anesthesia Care Unit (PACU) While participants are being prepared for anesthesia and
      surgery, they will once more be informed about the possible side-effects and discomfort
      associated with anesthesia and abdominal surgery. This in an effort to further manage
      expectations.

      Preoperative administration of multimodal analgesia regimen is initiated in the PACU. This
      will consist of 1 gram Paracetamol and 600 milligrams Gabapentin (300 mg if GFR <60 ml/min or
      age> 70 years) intravenously.

      Perioperative Participants are brought to the operating theater and the "time-out" check will
      be done. Here after the participant is prepared for anesthesia and surgery. Standard
      monitoring according to ASA guidelines will be applied.

      Anesthesia Pre-induction: Spinal anesthesia consisting of 12.5 mg Bupivacaine combined with
      intrathecal morphine 300 mcg will be administered intravenously.

      Induction: 1-2 mg per kg Propofol 2% plus TIVA (a mix of 50ml propofol plus 2% 500mcg Ultiva)
      at 4mcg/ml. In addition a bolus of Ketanest-S will be administered at 0.25 mg/kg. Dosages are
      adjusted to age and weight of the participant.

      Fluid therapy: only balanced crystalloids are chosen for intravenous fluids (Ringer Lactate
      or Stereofundin). Optimization of fluid therapy is achieved by guided Esophageal Doppler or
      Flo Trac System management up until the end of surgery. Continuous perfusion of Ringer
      Lactate / Stereofundin will be set at 3 ml/kg/hour IV.

      Ventilation: Optimal ventilation parameters will be obtained during surgery with: Total
      Volume 6-8 ml/kg; minimum FiO2 to prevent atelectasis and optimal PEEP (patients specific) to
      prevent peri- and postoperative atelectasis.

      Surgery - peroperative All participants will be operated on laparoscopically, in a true
      minimally invasive manner. With exception of the following two factors pertaining to ERAS
      2.0, all operations will be performed according to standard hospital protocols. (1) Starting
      intra-abdominal pressure will be set at 12 mmHg. During surgery, the intra-abdominal pressure
      will be gradually reduced to an end pressure of 8 mmHg. This method has been proven to be
      safe and is associated with less postoperative pain caused by laparoscopic insufflation. (2)
      Primary anastomosis will be performed intracorporeally as this method is associated with
      similar results to extracorporeal anastomosis. No additional mini-laparotomy will be
      performed. The specimen will be extracted through a suprapubic pfannenstiel incision. After
      surgery, routine postoperative measures will be used to omit sedation and commence recovery.
      If surgery was uncomplicated and performed under 2 hours, the urinary catheter will be
      removed in the operation theater.

      Postoperative Recovery ward After surgery, participants are brought to the recovery ward
      where further care will be given before transporting them to the surgical ward. Here
      participants are continuously monitored and checked for postoperative nausea, pain and
      discomfort. In case of nausea and/or vomiting, participants are treated according to standard
      hospital protocols. To bridge postoperative pain management, participants will receive 7.5mg
      Meloxicam postoperatively. Postoperative pain management consists of 1000mg Paracetamol IV
      every 6 hours. If necessary, 5-20mg Oxynorm (tablet) can be offered up to 6 times a day. To
      stimulate intake and gastrointestinal motility, patients are offered a popsicle on the
      recovery ward.

      Surgical ward

      Postoperative day 0:

      Upon arrival on the surgical ward, postoperative care is resumed according to standard
      hospital protocol with respect to anti-emetic care, patient monitoring and
      thromboprophylaxis. Routine physical examination and evaluation will take place.

      The postoperative care-points of ERAS 2.0 are: Minimal-opiate pain management; early removal
      of the urinary catheter, early oral intake; early stop of IV-fluids and early mobilization.
      Pain management is achieved with Paracetamol and Meloxicam, and if needed Oxynorm. Standard
      hospital dosages will be used. At 22:00 hours, if still in situ, urinary catheters will be
      removed. Intake is stimulated and participants will be offered food and beverages, starting
      with fluids gradually increasing to full oral intake tolerance of their normal diet.
      Participants are encouraged to sit up straight in bed as much as possible and to mobilize in
      their room.

      Postoperative day 1:

      The following day, participants will be evaluated for measure of recovery and suitability for
      discharge. Routine physical examination and evaluation will take place. The surgical incision
      sites will be evaluated and the abdomen will be examined for swelling, redness and for
      possible hematoma/bleeds. Participants will be evaluated for pain using the VAS pain score
      and will be evaluated for other signs of discomfort.

      Participants are considered as ' functionally recovered' and safe for discharge if the
      following criteria are met:

        -  Pain under control with oral analgesics (VAS <4)

        -  No symptoms of nausea and/or vomiting

        -  Flatus or passing of stools

        -  Oral intake possible (resumed full diet)

        -  Spontaneous micturition

        -  Able to mobilize independently

        -  No alarm signs present (fever, tachycardia, hypotension, dyspnea or somnolence).

      Participants are only discharged if they tick off all the requirements on the discharge
      checklist. Before discharge, their nurse will explain the recovery trajectory after
      discharge, including the telephonic aftercare. This includes pain management, dietary and
      mobilizing advice, thromboprophylaxis instructions and alarm symptoms to be weary of.
      Participants will receive a discharge folder with all necessary information, including all
      available contact numbers. The abovementioned information will be included in the discharge
      letter that patients receive upon leaving the surgical ward.

      Care after discharge Telephonic aftercare On the evening of the day of discharge,
      participants will be contacted by the attending nurse. A premade ERAS 2.0 checklist
      concerning recovery and possible alarm symptoms will be used to assess recovery. On
      postoperative day 4, participants will be contacted again via telephone by the attending
      nurse practitioner, and the same steps are repeated.

      Outpatient clinic Participants are given an appointment with a colorectal surgeon to be
      checked at the surgical outpatient clinic. During this appointment, the overall experience of
      the participant will be evaluated, together with his/her clinical recovery. The participant
      will be provided with an evaluation form.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This study is an investigator-initiated, single-center prospective feasibility study. This feasibility study will compare 30 consecutive patients following the ERAS 2.0 program to 30 patients of a retrospective cohort who followed the current standard ERAS 1.0 protocol.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Rate of the successful and safe application of the 23-hour accelerated ERAS 2.0 protocol for patients undergoing elective colorectal surgery.
time frame: 30 days
description: Success rate (feasibility) will be measured in readmission rate and safety will be measured with rate of serious adverse events (Clavien Dindo ≥3b).
measure: • Number of Participants who develop Postoperative Complications within 30 days
time frame: 30 day
description: • Number of Participants who develop Postoperative Complications within 30 days
measure: • Number of Participants with Postoperative Mortality within 30 days
time frame: 30 days
description: • Number of Participants with Postoperative Mortality within 30 days
measure: • Patient satisfaction evaluation by means of a questionnaire to evaluate the patients subjective experience during the duration of this study.
time frame: 10 days
description: • Patient satisfaction evaluation questionnaire to evaluate the patients subjective experience during the duration of this study and their subjective experience with the ERAS 2.0 protocol. In this questionnaire, patients will be asked to evaluate their experience based on 5 pre-set questions with a 10-point scale (1 being very bad and 10 being very good).
Were you sufficiently informed about the ERAS 2.0 protocol?
How did you experience the guidance provided (by nurses and doctors) within this protocol?
Was the care provided after hospital discharge satisfactory?
Was it necessary to contact the hospital after discharge? And if yes, how often?
What grade would you give this programme?
measure: • Demographic parameters
time frame: Upon inclusion
description: • Demographic parameters such as age, height, sex, comorbidities
measure: • Disease related demographics
time frame: After surgery and within 14 days after surgery
description: • Disease related demographics such as tumor type, location, type of resection, etc.
measure: • Short Nutritional Assessment Questionnaire (SNAQ)
time frame: Upon inclusion
description: • Short Nutritional Assessment Questionnaire (SNAQ) Lowest score: 0 and Highest score: 5
score 0 or 1: low risk of malnutrition score 2: moderate risk of malnutrition score ≥ 3: high risk of malnutrition, refer to dietician
measure: • Groningen Frailty Index (GFI)
time frame: Upon inclusion
description: • Groningen Frailty Index (GFI)
Lowest score: 0 and Highest score: 15
score <4: not frail score 4-5: frail score ≥ 6: really frail
arm group label: ERAS 2.0 group
arm group type: Experimental
description: Patients included in the ERAS 2.0 group will follow the ERAS 2.0 accelerated care protocol.
intervention type: Other
intervention name: ERAS 2.0
description: ERAS 2.0 accelerated protocol with adequate fluid management, pain control and truly minimally invasive surgery (intracorporeal anastomosis)
arm group label: ERAS 2.0 group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: James van Bastelaar, M.D., PhD
role: Principal Investigator
affiliation: GE-, Oncologic-surgeon
facility: 
country: Netherlands
citation: Al-Mazrou AM, Chiuzan C, Kiran RP. Factors influencing discharge disposition after colectomy. Surg Endosc. 2018 Jul;32(7):3032-3040. doi: 10.1007/s00464-017-6013-z. Epub 2017 Dec 27.
PMID: 29282575
citation: Dobradin A, Ganji M, Alam SE, Kar PM. Laparoscopic colon resections with discharge less than 24 hours. JSLS. 2013 Apr-Jun;17(2):198-203. doi: 10.4293/108680813X13654754535791.
PMID: 23925012
citation: Chand M, De'Ath HD, Rasheed S, Mehta C, Bromilow J, Qureshi T. The influence of peri-operative factors for accelerated discharge following laparoscopic colorectal surgery when combined with an enhanced recovery after surgery (ERAS) pathway. Int J Surg. 2016 Jan;25:59-63. doi: 10.1016/j.ijsu.2015.11.047. Epub 2015 Nov 30.
PMID: 26654893
citation: Rossi G, Vaccarezza H, Vaccaro CA, Mentz RE, Im V, Alvarez A, Quintana GO. Two-day hospital stay after laparoscopic colorectal surgery under an enhanced recovery after surgery (ERAS) pathway. World J Surg. 2013 Oct;37(10):2483-9. doi: 10.1007/s00268-013-2155-x.
PMID: 23881088
citation: Emmanuel A, Chohda E, Botfield C, Ellul J. Accelerated discharge within 72 hours of colorectal cancer resection using simple discharge criteria. Ann R Coll Surg Engl. 2018 Jan;100(1):52-56. doi: 10.1308/rcsann.2017.0149. Epub 2017 Sep 15.
PMID: 29022790
citation: Levy BF, Scott MJ, Fawcett WJ, Rockall TA. 23-hour-stay laparoscopic colectomy. Dis Colon Rectum. 2009 Jul;52(7):1239-43. doi: 10.1007/DCR.0b013e3181a0b32d.
PMID: 19571699
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
sharing ipd: No