Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections
NCT ID: NCT04550156
Last Updated: 2024-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1141 participants
INTERVENTIONAL
2020-10-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Arm
Patients are treated according to current local standards
No interventions assigned to this group
Colorectal Bundle Arm
Patients are treated according to the colorectal bundle
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing any left sided emergency or elective colorectal resections
* Patients should have given or will give a general consent
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hospital Centre Biel/Bienne
OTHER
Luzerner Kantonsspital
OTHER
Kantonsspital Aarau
OTHER
Kantonsspital Liestal
OTHER
Spital Limmattal Schlieren
OTHER
Kantonsspital Olten
OTHER
Clarunis - Universitäres Bauchzentrum Basel
OTHER
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Marco von Strauss und Tourney, PD Dr.
Role: PRINCIPAL_INVESTIGATOR
Clarunis - Universitäres Bauchzentrum Basel
Markus Zuber, Prof. Dr.
Role: STUDY_DIRECTOR
Clarunis - Universitäres Bauchzentrum Basel
Locations
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Kantonsspital Baselland
Liestal, Basel-Landschaft, Switzerland
Lantonsspital Aarau
Aarau, Canton of Aargau, Switzerland
Clarunis-universitäres Bauchzentrum
Basel, Canton of Basel-City, Switzerland
Spitalzentrum Biel
Biel/Bienne, Canton of Bern, Switzerland
Kantonsspital Luzern
Lucerne, Canton of Lucerne, Switzerland
Kantonsspital Olten
Olten, Canton of Solothurn, Switzerland
Spital Limmattal
Schlieren, Canton of Zurich, Switzerland
Countries
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References
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2017 European Society of Coloproctology (ESCP) Collaborating Group. The 2017 European Society of Coloproctology (ESCP) international snapshot audit of left colon, sigmoid and rectal resections - Executive Summary. Colorectal Dis. 2018 Sep;20 Suppl 6:13-14. doi: 10.1111/codi.14391. No abstract available.
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Wiesler B, Gass JM, Galli R, Worni M, Nebiker C, Muller A, Pabst M, Stimpfle D, Werlen L, von Strauss Und Torney M; Clarunis EvaCol Study Group. Is There Still a Need to Discuss the Use of Antibiotic Decontamination? Results of a Prospective Cohort Study Involving 999 Left-Sided Colorectal Resections. J Am Coll Surg. 2025 Sep 1;241(3):474-483. doi: 10.1097/XCS.0000000000001396. Epub 2025 Aug 14.
Wiesler B, Gass JM, Viehl CT, Muller A, Metzger J, Hartel M, Nebiker C, Rosenberg R, Galli R, Zingg U, Ochsner A, Eisner L, Pabst M, Worni M, Henschel M, von Flue M, Zuber M, von Strauss Und Torney M. Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections (EvaCol): Study Protocol of a Multicentre, Observational Trial. Int J Surg Protoc. 2022 Jul 14;26(1):57-67. doi: 10.29337/ijsp.177. eCollection 2022.
Other Identifiers
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EvaCol
Identifier Type: -
Identifier Source: org_study_id
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