CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,141 enrolled
Drug / intervention
Colorectal Bundleprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04550156
NCT04550156N/ACompleted

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

University Hospital, Basel, Switzerland·interventional·Posted Sep 16, 2020·Updated Mar 12, 2024

In Brief

A clinical study evaluating Colorectal Bundle for Colorectal Disorders and 4 related conditions. Completed, enrolled 1,141 participants across 7 sites.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 16, 2020
Enrollment StartOct 1, 2020
Primary CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.8 years ago

Interventions

Colorectal Bundleprocedure

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