CHASE : aCcelerated 23-Hour erAS Care for Colorectal Surgery
Condition: Colorectal Cancer; Enhanced Recovery After Surgery
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): ERAS 2.0
Intervention type(s): Other
Intervention description(s): ERAS 2.0 accelerated protocol with adequate fluid management, pain control and truly minimally invasive surgery (intracorporeal anastomosis)
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.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Colorectal Cancer; Enhanced Recovery After Surgery; Accelerated Care; Truly Minimally Invasive Surgery