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

NCT04550156 | Completed

• 1 other identifier: EvaCol
• Study Type: interventional
• Target: 1,141
• Locations: 1 country
• Sites: 7

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.

Conditions

Colorectal Disorders; Surgery--Complications; Colorectal Cancer; Anastomotic Leak; Complication of Surgical Procedure

Outcome Measures

Primary Outcomes (1)

• Comprehensive complication index

  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 Outcomes (5)

• Surgical side infections

  30 days

• Number of patients who died within 30 days

  30 days

• Hospital length of stay

  immediately after discharge

• Contribution margin

  immediately after discharge

• Rate of anastomotic leakage

  30 days

Study Arms (2)

Control Arm

NO INTERVENTION

Patients are treated according to current local standards

Colorectal Bundle Arm

EXPERIMENTAL

Patients are treated according to the colorectal bundle

Procedure: Colorectal Bundle

Interventions

Colorectal Bundle PROCEDURE

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

Colorectal Bundle Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Hospital Centre Biel/Bienne: collaborator
• Luzerner Kantonsspital: collaborator
• Kantonsspital Aarau: collaborator
• Kantonsspital Liestal: collaborator
• Spital Limmattal Schlieren: collaborator
• Kantonsspital Olten: collaborator
• Clarunis - Universitäres Bauchzentrum Basel: collaborator

Study Sites (7)

Kantonsspital Baselland

Liestal, Basel-Landschaft, 4410, Switzerland

Location

Lantonsspital Aarau

Aarau, Canton of Aargau, 5001, Switzerland

Location

Clarunis-universitäres Bauchzentrum

Basel, Canton of Basel-City, 4031, Switzerland

Location

Spitalzentrum Biel

Biel/Bienne, Canton of Bern, 2501, Switzerland

Location

Kantonsspital Luzern

Lucerne, Canton of Lucerne, 6004, Switzerland

Location

Kantonsspital Olten

Olten, Canton of Solothurn, 4600, Switzerland

Location

Spital Limmattal

Schlieren, Canton of Zurich, 8652, Switzerland

Location

Related Publications (27)

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• Wiesler B, Gass JM, Galli R, Worni M, Nebiker C, Muller A, Pabst M, Stimpfle D, Werlen L, von Strauss Und Torney M; Clarunis EvaCol Study Group. Is There Still a Need to Discuss the Use of Antibiotic Decontamination? Results of a Prospective Cohort Study Involving 999 Left-Sided Colorectal Resections. J Am Coll Surg. 2025 Sep 1;241(3):474-483. doi: 10.1097/XCS.0000000000001396. Epub 2025 Aug 14.

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• Wiesler B, Gass JM, Viehl CT, Muller A, Metzger J, Hartel M, Nebiker C, Rosenberg R, Galli R, Zingg U, Ochsner A, Eisner L, Pabst M, Worni M, Henschel M, von Flue M, Zuber M, von Strauss Und Torney M. Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections (EvaCol): Study Protocol of a Multicentre, Observational Trial. Int J Surg Protoc. 2022 Jul 14;26(1):57-67. doi: 10.29337/ijsp.177. eCollection 2022.

  PMID: 35891921 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco von Strauss und Tourney, PD Dr.

  Clarunis - Universitäres Bauchzentrum Basel

  PRINCIPAL INVESTIGATOR

• Markus Zuber, Prof. Dr.

  Clarunis - Universitäres Bauchzentrum Basel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomised, multicenter trial

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: September 16, 2020
• Study Start: October 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

CH (7)