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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,141
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
Kantonsspital Baselland
Liestal, Basel-Landschaft, Switzerland
Lantonsspital Aarau
Aarau, Canton of Aargau, Switzerland
Clarunis-universitäres Bauchzentrum
Basel, Canton of Basel-City, Switzerland
Spitalzentrum Biel
Biel/Bienne, Canton of Bern, Switzerland
Kantonsspital Luzern
Lucerne, Canton of Lucerne, Switzerland
Kantonsspital Olten
Olten, Canton of Solothurn, Switzerland
Spital Limmattal
Schlieren, Canton of Zurich, Switzerland
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) .
Time frame: 30 days
Surgical side infections
Rate of surgical side infections within 30 days
Time frame: 30 days
Number of patients who died within 30 days
Postoperative mortality within 30 days
Time frame: 30 days
Hospital length of stay
Length of hospital stay in days
Time frame: immediately after discharge
Contribution margin
Measured as the difference between allocated costs and billed and payed income for a particular case
Time frame: immediately after discharge
Rate of anastomotic leakage
Any radiologically or clinically diagnosed anastomotic leakage
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.