Clinical trial · Interventional
Timing Evaluation of Stoma Closure (TIMES). Early vs Late Closure of Stoma After Rectal Cancer Surgery.
NCT05284864CI-TRIAL-00057180TIMESunknownN/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 purpose of this study is to asses the safety and efficacy of early stoma closure (2-3 weeks after total mesorectal excision) vs late closure (16-24 weeks after mesorectal excision).
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 |
|---|---|---|---|
| Ileostomy Closure | — | UNRESOLVED | — |
| Ileostomy; Complications | — | UNRESOLVED | — |
| Ileostomy - Stoma | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Total Mesorectal Excision | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stoma closure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Early stoma closure
- description
- Stoma closure 2-3 weeks after rectal surgery.
- interventionNames
- Procedure: Stoma closure
- type
- ACTIVE_COMPARATOR
- label
- Late stoma closure
- description
- Stoma closure 16-24 weeks after rectal surgery.
- interventionNames
- Procedure: Stoma closure
Primary outcomes (1)
- measure
- Determine and compare morbidity and mortality rates in patients with early and late stoma closure
- timeFrame
- From rectal surgery to stoma closure surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with rectal cancer (with / without metastasis) (with / without chemoterapy or radiotherapy) * Patients undergoing low or ultra low anterior resection with anastomosis and stoma of protection. * Patients with no intraoperative or postoperative complications. * Radiological confirmation of the absence of anastomotic compilations (opaque enema or abdominal-pelvic CT scan with rectal contrast) * Confirmation by rectoscopy of the absence of anastomotic compilations Exclusion Criteria: * Rectal cancer surgeries without anastomosis. * Rectal cancer surgeries without stoma of protection.
References
Publications (0)
Data not yet available
No reference posted for this study.