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

University Hospital Basel

Status: Completed

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

Treatments: Procedure: Colorectal Bundle

Study type: Interventional

Funder types: Other

Identifiers

NCT04550156

EvaCol

Details and patient eligibility

About

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.

Enrollment: 1,141 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,141 participants in 2 patient groups

Control Arm

No Intervention group

Description:

Patients are treated according to current local standards

Colorectal Bundle Arm

Experimental group

Description:

Patients are treated according to the colorectal bundle

Treatment:

Procedure: Colorectal Bundle