Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections

Overview

The complication rate in colorectal surgery is high and shows a large variance depending on the patient and the treating surgeon. The primary aim of the presented study is to evaluate the introduction of a colorectal bundle to reduce the complication rate in left sided colorectal resections. The colorectal bundle is a catalog of measures consisting of several items These are for example preoperative risk stratification, antibiotic and mechanical bowel preparation and preoperative showering. The primary endpoint will be the complication rate measured as the comprehensive clinical index (CCI) within 30 days. Investigators will include patients that undergo elective or emergency left sided colorectal surgery.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 31, 2021

Interventions

  • Procedure: Colorectal Bundle
    • Preoperative optimization of the nutritional status: Perform nutritional risk screening (NRS), measure albumin or prealbumin preoperatively and initiate nutritional support Preoperative showering with an antiseptic agent Administer preoperative antibiotic prophylaxis Hair removal in the operative field with clippers Peri-, intra-, and postoperative warming to maintain body temperature Peri- and intraoperative glucose control Usage of a wound protection device Change of gloves and instruments after anastomosis Anastomosis only with experienced senior surgeon present in theatre for any elective and emergency procedures

Arms, Groups and Cohorts

  • No Intervention: Control Arm
    • Patients are treated according to current local standards
  • Experimental: Colorectal Bundle Arm
    • Patients are treated according to the colorectal bundle

Clinical Trial Outcome Measures

Primary Measures

  • Comprehensive complication index
    • Time Frame: 30 days
    • The primary endpoint is the comprehensive complication index (CCI) at 30 days after the index procedure, a continuous scale to measure surgical morbidity that has been developed on the basis of the Clavien Dindo Classification for surgical complications and summarizes and weighs all postoperative complications to a scale from 0 (no complications) to 100 (death of the patient) .

Secondary Measures

  • Surgical side infections
    • Time Frame: 30 days
    • Rate of surgical side infections within 30 days
  • Number of patients who died within 30 days
    • Time Frame: 30 days
    • Postoperative mortality within 30 days
  • Hospital length of stay
    • Time Frame: immediately after discharge
    • Length of hospital stay in days
  • Contribution margin
    • Time Frame: immediately after discharge
    • Measured as the difference between allocated costs and billed and payed income for a particular case
  • Rate of anastomotic leakage
    • Time Frame: 30 days
    • Any radiologically or clinically diagnosed anastomotic leakage

Participating in This Clinical Trial

Inclusion Criteria

  • aged ≥ 18 years
  • Patients undergoing any left sided emergency or elective colorectal resections
  • Patients should have given or will give a general consent

Exclusion Criteria

  • no general consent given
  • unable to provide informed general consent
  • vulnerable patients (Age < 18 years or patients with severe dementia)
  • the intervention is a reoperation within 30 days of primary operation

Exclusion criteria for an antibiotic decontamination subgroup:

  • known allergy to one of the applied antibiotic regimes
  • active bacterial infection requiring systemic antibiotics
  • IV or oral antibiotics in past 7 days prior to the planned decontamination
  • terminal kidney disease
  • unable to take antibiotic decontamination medication
  • pregnancy or breastfeeding
  • emergency or expedited surgery

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Basel, Switzerland
  • Collaborator
    • Hospital Centre Biel/Bienne
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marco von Strauss und Tourney, PD Dr., Principal Investigator, Clarunis – Universitäres Bauchzentrum Basel
    • Markus Zuber, Prof. Dr., Study Director, Clarunis – Universitäres Bauchzentrum Basel
  • Overall Contact(s)
    • Marco von Strauss und Tourney, PD Dr., +41 61 777 73 21, marco.vonstrauss@clarunis.ch

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