Clinical trial · Observational
APEMESH- Preventing Perineal Complications After Abdominoperineal Resection
NCT04334421CI-TRIAL-00073497completedClinicalTrials.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)
Abdominoperineal resection leaves an empty space to be filled by mesh or musculocutaneus flap. Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy is a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity. The role of omentoplasty at APR is controversial. Previous studies on synthetic mesh repair on perineum are almost lacking.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominoperineal Resection | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Wound Heal | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Composite mesh | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Mesh group
- description
- After resection, pelvic floor is reconstructed by synthetic composite mesh (Symbotex, Medtronic) and covered with subcutaneous flap.
- interventionNames
- Device: Composite mesh
Primary outcomes (1)
- measure
- Comprehensive Complication index
- timeFrame
- 30 days
- description
- Comprehensive Complication index is used to evaluate outcome
Secondary outcomes (8)
- measure
- Surgical site infection
- timeFrame
- 30 days
- description
- Surgical site infection classified by Clavien-Dindo score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Abdominoperineal resection and permanent colostoma Exclusion Criteria: * Patient with a comorbid illness of condition that would preclude the use of surgery (ASA5) * Potentially curable resection not possible * Patient undergoing emergency procedure * Metastatic disease * Pregnant or suspected pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.