Clinical trial · Interventional
Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections
NCT04550156CI-TRIAL-00074933completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomotic Leak | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Disorders | — | UNRESOLVED | — |
| Complication of Surgical Procedure | — | UNRESOLVED | — |
| Surgery--Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colorectal Bundle | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- Patients are treated according to current local standards
- type
- EXPERIMENTAL
- label
- Colorectal Bundle Arm
- description
- Patients are treated according to the colorectal bundle
- interventionNames
- Procedure: Colorectal Bundle
Primary outcomes (1)
- measure
- Comprehensive complication index
- timeFrame
- 30 days
- description
- 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) .
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (28)
- BACKGROUNDBergvall M, Skullman S, Kodeda K, Larsson PA. Better survival for patients with colon cancer operated on by specialized colorectal surgeons - a nationwide population-based study in Sweden 2007-2010. Colorectal Dis. 2019 Dec;21(12):1379-1386. doi: 10.1111/codi.14760. Epub 2019 Jul 30. PMID 31293019
- BACKGROUND2017 European Society of Coloproctology (ESCP) collaborating group. Safety of primary anastomosis following emergency left sided colorectal resection: an international, multi-centre prospective audit. Colorectal Dis. 2018 Sep;20 Suppl 6:47-57. doi: 10.1111/codi.14373. PMID 30255647
- BACKGROUND2017 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. PMID 30255645
- BACKGROUNDBorstlap WAA, Westerduin E, Aukema TS, Bemelman WA, Tanis PJ; Dutch Snapshot Research Group. Anastomotic Leakage and Chronic Presacral Sinus Formation After Low Anterior Resection: Results From a Large Cross-sectional Study. Ann Surg. 2017 Nov;266(5):870-877. doi: 10.1097/SLA.0000000000002429. PMID 28746154
- BACKGROUNDFrasson M, Flor-Lorente B, Rodriguez JL, Granero-Castro P, Hervas D, Alvarez Rico MA, Brao MJ, Sanchez Gonzalez JM, Garcia-Granero E; ANACO Study Group. Risk Factors for Anastomotic Leak After Colon Resection for Cancer: Multivariate Analysis and Nomogram From a Multicentric, Prospective, National Study With 3193 Patients. Ann Surg. 2015 Aug;262(2):321-30. doi: 10.1097/SLA.0000000000000973. PMID 25361221
- BACKGROUNDAmri R, Dinaux AM, Kunitake H, Bordeianou LG, Berger DL. Risk Stratification for Surgical Site Infections in Colon Cancer. JAMA Surg. 2017 Jul 1;152(7):686-690. doi: 10.1001/jamasurg.2017.0505. PMID 28403477