Trials / Completed
CompletedNCT04550156
Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,141 (actual)
- Sponsor
- University Hospital, Basel, Switzerland · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Colorectal Disorders
- Surgery--Complications
- Colorectal Cancer
- Anastomotic Leak
- Complication of Surgical Procedure
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Colorectal 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 |
Timeline
- Start date
- 2020-10-01
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
- First posted
- 2020-09-16
- Last updated
- 2024-03-12
Locations
7 sites across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT04550156. Inclusion in this directory is not an endorsement.