Clinical trial · Interventional
Efficacy of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure
Multicentric, Prospective, Randomized and Simple Blind Study to Determine the Efficacy of the Placement of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure in Patients With a Prior Rectal Resection for Cancer
NCT02896686CI-TRIAL-00023838ILEOMESHunknownPhase 4ClinicalTrials.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 study is to determine the efficacy of the placement of an onlay mesh to prevent incisional hernia after loop ileostomy closure in patients with a prior rectal resection for cancer
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 |
|---|---|---|---|
| Incisional Hernia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical Follow Up | Other | — | UNRESOLVED |
| Control CT | Radiation | — | UNRESOLVED |
| Reinforcement with Light Polypropylene Mesh | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Abdominal wall closure will be done by continuous polydioxanone (PDS) suture following a SL:WL ratio of 4:1, and the skin will be closed using a subcutaneous purse-string closure
- interventionNames
- Radiation: Control CT
- Other: Clinical Follow Up
- type
- EXPERIMENTAL
- label
- Reinforcement with Mesh
- description
- Abdominal wall closure will be done by continous polydioxanone (PDS) suture following a SL:WL ratio of 4:1. The incision is reinforced with onlay placement of a light polypropylene mesh (3 cm wide and the length corresponding to the incision), fixed to the aponeurosis with interrupted polyglactin (Vycril) suture. The skin will be closed using a subcutaneous purse-string closure
- interventionNames
- Radiation: Control CT
- Other: Clinical Follow Up
- Procedure: Reinforcement with Light Polypropylene Mesh
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients operated on in hospitals in Catalunya for loop ileostomy closure after a prior rectal resection for rectal cancer. * elective surgery for loop ileostomy closure * ASA (American Society of Anesthesiologists)\<4 Exclusion Criteria: * allergy or intolerance to polypropilene * patients with a prior mesh on the abdominal wall * ASA ≥IV * patients with a life expectancy of \<12 months * chronic renal failure in haemodialysis * patients on steroid therapy
References
Publications (1)
- DERIVEDOlona C, Caro-Tarrago A, Casanova R, Manas MJ, Ruiz C, Goncalves C, Sales R, Jorba R. Prevention of incisional hernia in ileostomy reversal. 5-year follow-up prospective randomized controlled trial. Hernia. 2025 Dec 12;30(1):29. doi: 10.1007/s10029-025-03531-4. PMID 41385147