Anastomotic Leak, Colorectal Cancer, Colorectal Disorders, Complication of Surgical Procedure, Surgery--Complications
Conditions
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.
Interventions
PROCEDUREColorectal Bundle
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
Sponsors
Hospital Centre Biel/Bienne
Luzerner Kantonsspital
Kantonsspital Aarau
Kantonsspital Liestal
Spital Limmattal Schlieren
Kantonsspital Olten
Clarunis - Universitäres Bauchzentrum Basel
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, randomised, multicenter trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Hospital length of stay | immediately after discharge | Length of hospital stay in 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 |
Countries
Switzerland
Outcome results
None listed