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

Not Applicable

Completed

• Conditions: Surgery--Complications; Anastomotic Leak; Colorectal Cancer; Complication of Surgical Procedure; Colorectal Disorders
• Interventions: Procedure: Colorectal Bundle

• Registration Number: NCT04550156
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-16
• Study Start: 2020-10-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1141

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colorectal Bundle Arm	Colorectal Bundle	Patients are treated according to the colorectal bundle

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (7)

Clarunis-universitäres Bauchzentrum; 🇨🇭 Basel, Kanton Basel Stadt, Switzerland

Lantonsspital Aarau; 🇨🇭 Aarau, Kanton Aargau, Switzerland

Spital Limmattal; 🇨🇭 Schlieren, Kanton Zürich, Switzerland

Kantonsspital Baselland; 🇨🇭 Liestal, Kanton Basel-Land, Switzerland

Spitalzentrum Biel; 🇨🇭 Biel, Kanton Bern, Switzerland

Kantonsspital Luzern; 🇨🇭 Luzern, Kanton Luzern, Switzerland

Kantonsspital Olten; 🇨🇭 OLten, Kanton Solothurn, Switzerland