Clinical trial · Interventional
Trial of Collagen Mesh for Prevention of Ventral Hernia After Surgery for Advanced Pelvic Cancer
Randomized Controlled Trial of Collagen Mesh for Prevention of Ventral Hernia in Patients With Vertical Rectus Abdominis Musculocutaneus Flap for Advanced Pelvic Malignancy
NCT00647569CI-TRIAL-00012035VRAMcompletedPhase 3ClinicalTrials.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 aim of the present project is to investigate whether use of biological mesh at the donor site of the rotation flap in closure of the abdominal wall reduce the frequency of incisional hernia formation compared to the usual abdominal wall closure after abdominal rotation flap operation in surgery for advanced pelvic cancer.
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 |
|---|---|---|---|
| Incisional Hernia | — | UNRESOLVED | — |
| Pelvic Cancer | Malignant Pelvic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional facial closure | Procedure | — | UNRESOLVED |
| Mesh repair | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- No previous major abdominal surgery
- interventionNames
- Procedure: Mesh repair
- Procedure: Conventional facial closure
- type
- EXPERIMENTAL
- label
- B
- description
- Previous major abdominal surgery
- interventionNames
- Procedure: Mesh repair
- Procedure: Conventional facial closure
Primary outcomes (1)
- measure
- incisional hernia formation determined by CT scan 1 year postoperative
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients operated with a vertical rectus abdominis musculocutaneus flap after abdominoperineal resection for advanced pelvic cancer. Exclusion Criteria: * Pre or perioperative knowledge of disseminated malignancy * Unable to follow the control program * Known allergy to pig * Compromised immune defense * Artificial heart valve or recent (\< 3 months) implanted foreign body * Age \< 18 years
References
Publications (0)
Data not yet available
No reference posted for this study.