Clinical trial · Interventional
"Cross" Closure for Reconstructing the Perineal Wound of Abdominoperineal Resection
"Cross" Closure for Reconstructing the Perineal Wound of Abdominoperineal Resection in Rectal and Anal Cancer Patients: a Multi-center, Randomized, Open-Label, Positive, Parallel Controlled Clinical Trial
- 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)
How to reduce the complications of perineal wound after abdominoperineal resection (APR) has always been a hot topic in the medical field.To reduce the complications of perineal wound and the primary healing of perineal wound must meet the two principles of "unobstructed drainage" and " reduced tension closure".This concept is similar to the concepts of closure of enterostomy in rectal cancer patients. It was reported that use of cross-stitch closure can significantly reduce complications of closure of enterostomy. So the investigator ever used the "cross" closure to reconstruct the perineal wound of APR, which was really decrease the complications of perineal wound. However, more clinical trails was needed to confirm the conclusion.
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 |
|---|---|---|---|
| Anal Canal Cancer | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| "Cross" closure | Procedure | — | UNRESOLVED |
| Traditional Closure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Traditional Closure
- description
- Patients receive primary closure discontinuously for reconstruction of APR perineal wound
- interventionNames
- Procedure: Traditional Closure
- type
- EXPERIMENTAL
- label
- "Cross" Closure
- description
- Patients receive "cross" closure for reconstruction of APR perineal wound
- interventionNames
- Procedure: "Cross" closure
Primary outcomes (1)
- measure
- Complication rate of perineal wound
- timeFrame
- Within 30 days after operation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age: 18-75 years old; 2. ECOG performance status: 0-2; 3. Histologically confirmed rectal cancer or anal canal cancer; 4. Completely resected the primary tumor; 5. No evidence of distant metastasis; 6. Tolerable general anesthesia; 7. Total radiation dose of 45-50 Gy needed if the patient needs to receive routine segmental radiotherapy; 8. Provision of written informed consent. Exclusion Criteria: 1. Emergency surgery required when the patients combined with acute ileus, perforation and hemorrhage; 2. Extralevator abdominoperineal resection needed; 3. American Society of Anesthesiologists (ASA) IV or V; 4. Combined with other tumors; 5. Severe mental illness; (7)Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease; (8)Expectation of lateral lymph node dissection preoperatively
References
Publications (0)
Data not yet available