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

March 11, 2024 updated by: University Hospital, Basel, Switzerland
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1141

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Kanton Aargau
      • Aarau, Kanton Aargau, Switzerland, 5001
        • Lantonsspital Aarau
    • Kanton Basel Stadt
      • Basel, Kanton Basel Stadt, Switzerland, 4031
        • Clarunis-universitäres Bauchzentrum
    • Kanton Basel-Land
      • Liestal, Kanton Basel-Land, Switzerland, 4410
        • Kantonsspital Baselland
    • Kanton Bern
      • Biel, Kanton Bern, Switzerland, 2501
        • Spitalzentrum Biel
    • Kanton Luzern
      • Luzern, Kanton Luzern, Switzerland, 6004
        • Kantonsspital Luzern
    • Kanton Solothurn
      • OLten, Kanton Solothurn, Switzerland, 4600
        • Kantonsspital Olten
    • Kanton Zürich
      • Schlieren, Kanton Zürich, Switzerland, 8652
        • Spital Limmattal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Arm
Patients are treated according to current local standards
Experimental: Colorectal Bundle Arm
Patients are treated according to the colorectal bundle
Procedure: Colorectal Bundle
  1. Preoperative optimization of the nutritional status: Perform nutritional risk screening (NRS), measure albumin or prealbumin preoperatively and initiate nutritional support
  2. Preoperative showering with an antiseptic agent
  3. Administer preoperative antibiotic prophylaxis
  4. Hair removal in the operative field with clippers
  5. Peri-, intra-, and postoperative warming to maintain body temperature
  6. Peri- and intraoperative glucose control
  7. Usage of a wound protection device
  8. Change of gloves and instruments after anastomosis
  9. Anastomosis only with experienced senior surgeon present in theatre for any elective and emergency procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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) .
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Kantonsspital Aarau
Luzerner Kantonsspital
Spital Limmattal Schlieren
Hospital Centre Biel/Bienne
Kantonsspital Olten
Kantonsspital Liestal
Clarunis - Universitäres Bauchzentrum Basel

Investigators

  • Principal Investigator: Marco von Strauss und Tourney, PD Dr., Clarunis - Universitäres Bauchzentrum Basel
  • Study Director: Markus Zuber, Prof. Dr., Clarunis - Universitäres Bauchzentrum Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

August 19, 2020

First Submitted That Met QC Criteria

September 14, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EvaCol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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