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Completed

NCT Number: NCT04550156

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

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.

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Key information

Conditions

Colorectal Disorders Anastomotic Leak Colonic Diseases Colorectal Cancer Colorectal Neoplasms Complication of Surgical Procedure Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases Surgery--Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kantonsspital Baselland, Liestal, Basel-Landschaft, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

for an antibiotic decontamination subgroup:

  • known allergy to one of the applied antibiotic regimes
  • active bacterial infection requiring systemic antibiotics
  • IV or oral antibiotics in past 7 days prior to the planned decontamination
  • terminal kidney disease
  • unable to take antibiotic decontamination medication
  • pregnancy or breastfeeding
  • emergency or expedited surgery

Treatment and study plan

Colorectal Bundle

Procedure
  • Preoperative optimization of the nutritional status: Perform nutritional risk screening (NRS), measure albumin or prealbumin preoperatively and initiate nutritional support
  • Preoperative showering with an antiseptic agent
  • Administer preoperative antibiotic prophylaxis
  • Hair removal in the operative field with clippers
  • Peri-, intra-, and postoperative warming to maintain body temperature
  • Peri- and intraoperative glucose control
  • Usage of a wound protection device
  • Change of gloves and instruments after anastomosis
  • Anastomosis only with experienced senior surgeon present in theatre for any elective and emergency procedures

Primary outcomes

  1. Comprehensive complication index

    Time frame: 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 outcomes

  1. Surgical side infections

    Time frame: 30 days

    Rate of surgical side infections within 30 days

  2. Number of patients who died within 30 days

    Time frame: 30 days

    Postoperative mortality within 30 days

  3. Hospital length of stay

    Time frame: immediately after discharge

    Length of hospital stay in days

  4. Contribution margin

    Time frame: immediately after discharge

    Measured as the difference between allocated costs and billed and payed income for a particular case

  5. Rate of anastomotic leakage

    Time frame: 30 days

    Any radiologically or clinically diagnosed anastomotic leakage

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Clarunis - Universitäres Bauchzentrum Basel
  • Hospital Centre Biel/Bienne
  • Kantonsspital Aarau
  • Kantonsspital Liestal
  • Kantonsspital Olten
  • Luzerner Kantonsspital
  • Spital Limmattal Schlieren

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2020
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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