Clinical trial · Interventional
APEMESH II - Perineal Reconstruction
Apemesh II - Perineal Reconstruction With Mesh Enhanced Gluteus Plasty
NCT04779125CI-TRIAL-00073549completedN/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 objective of this pilot study is to assess the safety, functional outcome, feasibility and the potential benefits of synthetic mesh strip and gluteus flap reconstruction in perineum in case-control setting.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gluteus plasty enhanced with Progrip self gripping mesh | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gluteus plasty enhanced with Progrip self gripping mesh
- description
- All study patietns will have a gluteus enhanced plasty after abdominoperineal reconstruction.
- interventionNames
- Procedure: Gluteus plasty enhanced with Progrip self gripping mesh
Primary outcomes (1)
- measure
- Complications
- timeFrame
- 30 days
- description
- Comprehensive complication index
Secondary outcomes (9)
- measure
- Surgical site infections
- timeFrame
- 30 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Curative intent abdominoperineal resection and permanent colostomy Exclusion Criteria: * Patient with a comorbid illness or condition that would preclude the use of surgery (ASA 4- 5) * Immunosupression (cortisone \>10mg/day) or severe malnutrition (BMI \<20) * Diabetes with 1 or more organ damage * Dialysis treatment * Hepatic cirrhosis Child-Bugh B-C * Potentially curable resection not possible * Patient undergoing emergency procedures * Metastatic disease * Vaginal resection, pelvic exenteration and sacrum resection * Vaginal perforation * Pelvic abscess or perforated tumor * Pregnant or suspected pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.