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

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Recruiting
CT.gov ID
NCT04550156
Collaborator
Hospital Centre Biel/Bienne (Other), Luzerner Kantonsspital (Other), Kantonsspital Aarau (Other), Kantonsspital Liestal (Other), Spital Limmattal Schlieren (Other), Kantonsspital Olten (Other), Clarunis - Universitäres Bauchzentrum Basel (Other)
298
Enrollment
7
Locations
2
Arms
23
Anticipated Duration (Months)
42.6
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Colorectal Bundle
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
298 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, randomised, multicenter trialProspective, randomised, multicenter trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

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
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

Outcome Measures

Primary Outcome Measures

  1. Comprehensive complication index [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 Outcome Measures

  1. Surgical side infections [30 days]

    Rate of surgical side infections within 30 days

  2. Number of patients who died within 30 days [30 days]

    Postoperative mortality within 30 days

  3. Hospital length of stay [immediately after discharge]

    Length of hospital stay in days

  4. Contribution margin [immediately after discharge]

    Measured as the difference between allocated costs and billed and payed income for a particular case

  5. Rate of anastomotic leakage [30 days]

    Any radiologically or clinically diagnosed anastomotic leakage

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lantonsspital Aarau Aarau Kanton Aargau Switzerland 5001
2 Clarunis-universitäres Bauchzentrum Basel Kanton Basel Stadt Switzerland 4031
3 Kantonsspital Baselland Liestal Kanton Basel-Land Switzerland 4410
4 Spitalzentrum Biel Biel Kanton Bern Switzerland 2501
5 Kantonsspital Luzern Luzern Kanton Luzern Switzerland 6004
6 Kantonsspital Olten OLten Kanton Solothurn Switzerland 4600
7 Spital Limmattal Schlieren Kanton Zürich Switzerland 8652

Sponsors and Collaborators

  • University Hospital, Basel, Switzerland
  • Hospital Centre Biel/Bienne
  • Luzerner Kantonsspital
  • Kantonsspital Aarau
  • Kantonsspital Liestal
  • Spital Limmattal Schlieren
  • Kantonsspital Olten
  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT04550156
Other Study ID Numbers:
  • EvaCol
First Posted:
Sep 16, 2020
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022
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
Additional relevant MeSH terms:
Anastomotic Leak

Study Results

No Results Posted as of May 24, 2022