Clinical trial · Observational
Volume-outcome Relationship in Rectal Cancer Surgery
NCT04761536CI-TRIAL-00050231completedClinicalTrials.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)
Hospital centralization effect is reported to lower complications and mortality especially for high risk and complex general surgery operations, including colorectal surgery. However, no linear relation between volume and outcome has been demonstrated. Aim of the study was to evaluate the increased surgical volume effect on early outcomes of patient undergoing restorative anterior rectal resection (ARR).
Conditions
Conditions (2)
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 Rectum | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rectal cancer case centralization | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- A
- description
- patients undergoing ARR with primary anastomosis between November 2016 and December 2020 after centralization of rectal cancer cases
- interventionNames
- Other: Rectal cancer case centralization
- label
- B
- description
- patients undergoing ARR with primary anastomosis between January 2006 and October 2016
Primary outcomes (1)
- measure
- Anastomotic leak
- timeFrame
- up to 30 days after discharge
- description
- rate of any postoperative leakage of colo-rectal anastomosis clinically, radiologically or endoscopically demonstrated
Secondary outcomes (14)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * diagnosis of a cancer located in the rectum, defined according to the international definition by D'Souza et al., * elective setting * anterior rectal resection with primary anastomosis (with or without diverting loop ileostomy). Exclusion Criteria: * age below age of 18, * inflammatory bowel disease, * acquired or congenital immunodeficiency, * preoperative infection, * pregnancy, * ASA IV, * presence of synchronous cancers, * abdominoperineal resection (APR), * failure to perform rectal resection and primary anastomosis, * emergency setting.
References
Publications (0)
Data not yet available
No reference posted for this study.