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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Procedure: Colorectal Bundle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomised, multicenter trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm<br>Patients are treated according to current local standards | |
| Experimental: Colorectal Bundle Arm<br>Patients are treated according to the colorectal bundle | Procedure: Colorectal Bundle<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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