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

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

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

Sponsors & Collaborators

• Hospital Centre Biel/Bienne

  collaborator OTHER

• Luzerner Kantonsspital

  collaborator OTHER

• Kantonsspital Aarau

  collaborator OTHER

• Kantonsspital Liestal

  collaborator OTHER

• Spital Limmattal Schlieren

  collaborator OTHER

• Kantonsspital Olten

  collaborator OTHER

• Clarunis - Universitäres Bauchzentrum Basel

  collaborator OTHER

• University Hospital, Basel, Switzerland

  lead OTHER

Principal Investigators

• Marco von Strauss und Tourney, PD Dr. · Clarunis - Universitäres Bauchzentrum Basel

• Markus Zuber, Prof. Dr. · Clarunis - Universitäres Bauchzentrum Basel

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-01

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• Switzerland

Study Locations