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

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ClinicalTrials.gov Identifier: NCT04550156
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : November 4, 2020
Sponsor:
Collaborators:
Hospital Centre Biel/Bienne
Luzerner Kantonsspital
Kantonsspital Aarau
Kantonsspital Liestal
Spital Limmattal Schlieren
Kantonsspital Olten
Clarunis - Universitäres Bauchzentrum Basel
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment Phase
Colorectal Disorders Surgery--Complications Colorectal Cancer Anastomotic Leak Complication of Surgical Procedure Procedure: Colorectal Bundle Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 298 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomised, multicenter trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

Arm Intervention/treatment
No Intervention: Control Arm
Patients are treated according to current local standards
Experimental: Colorectal Bundle Arm
Patients are treated according to the colorectal bundle
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04550156


Contacts
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Contact: Marco von Strauss und Tourney, PD Dr. +41 61 777 73 21 marco.vonstrauss@clarunis.ch
Contact: Markus Zuber, Prof. Dr. +41 61 777 73 28 markus.zuber@clarunis.ch

Locations
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Switzerland
Lantonsspital Aarau Recruiting
Aarau, Kanton Aargau, Switzerland, 5001
Contact: Mark Hartel, Prof. Dr.    +41 62 838 45 02    mark.hartel@ksa.ch   
Clarunis-universitäres Bauchzentrum Recruiting
Basel, Kanton Basel Stadt, Switzerland, 4031
Contact: Marco von Strauss und Torney, PD Dr.    +41 61 777 73 21    marco.vonstrauss@clarunis.ch   
Contact: Markus Zuber, Prof. Dr.    +41 61 777 73 28    markus.zuber@clarunis.ch   
Kantonsspital Baselland Recruiting
Liestal, Kanton Basel-Land, Switzerland, 4410
Contact: Robert Rosenberg, Prof. Dr.    +41 61 925 21 51    robert.rosenberg@ksbl.ch   
Spitalzentrum Biel Recruiting
Biel, Kanton Bern, Switzerland, 2501
Contact: Carsten Viehl, Prof. Dr.    +41 32 324 37 64    carsten.viehl@unibas.ch   
Kantonsspital Luzern Recruiting
Luzern, Kanton Luzern, Switzerland, 6004
Contact: Jürg Metzger, Prof. Dr.    +41 41 205 48 60    juerg.metzger@luks.ch   
Kantonsspital Olten Recruiting
OLten, Kanton Solothurn, Switzerland, 4600
Contact: Lukas Eisner, Dr.    +41 62 311 41 74    lukas.eisner@spital.so.ch   
Spital Limmattal Recruiting
Schlieren, Kanton Zürich, Switzerland, 8652
Contact: Urs Zingg, Prof. Dr.    +41 44 736 81 29    urs.zingg@spital-limmattal.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Hospital Centre Biel/Bienne
Luzerner Kantonsspital
Kantonsspital Aarau
Kantonsspital Liestal
Spital Limmattal Schlieren
Kantonsspital Olten
Clarunis - Universitäres Bauchzentrum Basel
Investigators
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Principal Investigator: Marco von Strauss und Tourney, PD Dr. Clarunis - Universitäres Bauchzentrum Basel
Study Director: Markus Zuber, Prof. Dr. Clarunis - Universitäres Bauchzentrum Basel
Publications:

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04550156    
Other Study ID Numbers: EvaCol
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Anastomotic Leak
Postoperative Complications
Pathologic Processes