Clinical trial · Observational
Treatment of Anastomotic Leakage After Rectal Cancer Resection
Treatment of AnastomotiC Leakage After Rectal Cancer Resection. TENTACLE Rectum Study
NCT04127734CI-TRIAL-00041215TENTACLE:RunknownClinicalTrials.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 TENTACLE: Rectum study is a multinational retrospective cohort study that includes patients with anastomotic leakage after rectal cancer resection. The study aims to develop an anastomotic leakage severity score and to evaluate the efficacy of different treatments of anastomotic leakage.
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 |
|---|---|---|---|
| The efficacy of various interventions for anastomotic leakage after rectal cancer resection are investigated | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 1-year stomafree survival
- timeFrame
- 1 year
- description
- Survival of the patient and absence of a stoma
Secondary outcomes (2)
- measure
- ICU length of stay
- timeFrame
- 1 year
- description
- Length of stay in the intensive care unit
- measure
- 1 year mortality
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18 years or older; * Cancer located in the rectum, defined according to the international definition of the rectum consensus \[D'Souza 2019\]; * Rectal cancer resection with primary anastomosis (with or without diverting loop ileostomy) for either primary cancer, completion after local excision or salvage resection for regrowth after watch \& wait or local excision; * Postoperative anastomotic leakage according to the following definition: "a breach in a surgical join between two hollow viscera, with or without active leak of luminal contents" \[Peel 1991\]. Exclusion Criteria: * Rectal resection for benign disease; * Rectal resection for recurrent rectal cancer after previous low anterior resection or other primary malignancies; * Multivisceral resection (lateral lymph node dissection can be included) * Emergency resection;
References
Publications (0)
Data not yet available
No reference posted for this study.