Clinical trial NCT04550156: Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections
Official title: Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Disorders
Surgery--Complications
Colorectal Cancer
Anastomotic Leak
Complication of Surgical Procedure
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Hospital Centre Biel/Bienne
name: Luzerner Kantonsspital
name: Kantonsspital Aarau
name: Kantonsspital Liestal
name: Spital Limmattal Schlieren
name: Kantonsspital Olten
name: Clarunis - Universitäres Bauchzentrum Basel
First posted: 2020-09-16
Enrollment: 1141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomised, multicenter trial
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Comprehensive complication index
timeFrame: 30 days
Secondary outcomes:
measure: Surgical side infections
timeFrame: 30 days
measure: Number of patients who died within 30 days
timeFrame: 30 days
measure: Hospital length of stay
timeFrame: immediately after discharge
measure: Contribution margin
timeFrame: immediately after discharge
measure: Rate of anastomotic leakage
timeFrame: 30 days
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Lantonsspital Aarau
state: Kanton Aargau
city: Basel
country: Switzerland
facility: Clarunis-universitäres Bauchzentrum
state: Kanton Basel Stadt
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland
state: Kanton Basel-Land
city: Biel
country: Switzerland
facility: Spitalzentrum Biel
state: Kanton Bern
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern
state: Kanton Luzern
city: OLten
country: Switzerland
facility: Kantonsspital Olten
state: Kanton Solothurn
city: Schlieren
country: Switzerland
facility: Spital Limmattal
state: Kanton Zürich
Study officials:
affiliation: Clarunis - Universitäres Bauchzentrum Basel
name: Marco von Strauss und Tourney, PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clarunis - Universitäres Bauchzentrum Basel
name: Markus Zuber, Prof. Dr.
role: STUDY_DIRECTOR
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