Clinical trial · Interventional
PReventive cOlostomy vs Ileostomy in Low anTErior reCTal Resection
Multi-center, Randomized, Parallel-group, Superiority Study to Compare Outcomes of Protective Double-Barrelled Colostomy Versus Protective Double-Barrelled Ileostomy in Low Anterior Resection for Rectal Cancer
- 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 type of preventive intestinal stoma (colostomy/ileostomy) after low anterior rectal resection rectum is still a debate. This study purpose is to demonstrate that preventive loop ileostomy is characterized by a higher readmission rate caused by dehydration, in comparison with the loop colostomy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low anterior resection with protective loop ileostomy | Procedure | — | UNRESOLVED |
| Low anterior resection with protective loop transverse colostomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Ileostomy
- description
- Loop protective ileostomy as a defunction mean after low anterior resection with D3 lymphnode dissection
- interventionNames
- Procedure: Low anterior resection with protective loop ileostomy
- type
- ACTIVE_COMPARATOR
- label
- Colostomy
- description
- Loop protective transverse colostomy as a defunction mean after low anterior resection with D3 lymphnode dissection
- interventionNames
- Procedure: Low anterior resection with protective loop transverse colostomy
Primary outcomes (1)
- measure
- The rate of readmissions due to severe dehydratation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Mid- and low rectal cancer * Age ≧ 18 * TME * ASA ≦ 3 * No previous stoma formation * Informed consent for participation Exclusion Criteria: * Patients lost during the follow-up * Refusal of the patient from further participation in the study * Inability of stoma formation
References
Publications (0)
Data not yet available