Clinical trial · Observational
Perineal Reconstruction Following eLAPE and Simultaneous Stoma Sublay Reinforcement
Perineal Reconstruction Following Extralevator Abdominoperineal Excision of Rectum and Simultaneous Stoma Sublay Reinforcement
NCT01670851CI-TRIAL-00020106PRESSURcompletedClinicalTrials.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)
This is a prospective, multicenter, single arm, observational pilot study to assess the clinical outcomes of Strattice Reconstructive Tissue Matrix for perineal reconstruction following eLAPE and simultaneous stoma reinforcement.
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 |
|---|---|---|---|
| Strattice | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Strattice
- description
- eLAPE
- interventionNames
- Device: Strattice
Primary outcomes (1)
- measure
- Perineal wound healing
- timeFrame
- 12 months
- description
- Perineal wound healing will be assessed using the Southamptom Wound Scoring System and perineal pain assessed using a visual analogue scale (VAS) daily during hospital stay and then POD 7, 30 and months 3, 6 and 12.
Secondary outcomes (2)
- measure
- Incidence of perineal herniation
- timeFrame
- 24 months
- description
- Incidence of perineal hernia
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Primary cancers undergoing curative surgery (R0) * Life expectancy \> 2 yrs * Neoadjuvant radiotherapy with or without chemotherapy Exclusion Criteria: * Pelvic extenteration or extended resections * Previously irradiated patients (i.e. radiation therapy for a previous cancer) * Co-morbidities of: systemic infection, chronic liver failure, chronic renal failure, HIV, Hepatitis C, other advanced/metastatic cancer, collagen disorder * sensitivity to porcine derived products or polysorbate
References
Publications (0)
Data not yet available
No reference posted for this study.