Clinical trial · Interventional
Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection
Prophylactic Mesh Placement During Temporary Stoma Closure: a Prospective Randomized Phase III Clinical Trial
- 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 goal of this clinical trial is to compare the efficacy of using polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer and non-mesh repair. The main question it aims to answer is: can mesh help prevent hernia? Participants will be divided into 2 groups: with and without mesh using. They must be followed up for 2 years after enrollment in the study. Researchers will compare mesh and non-mesh groups to evaluate the benefits and harms of mesh using in hernia prevention.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hernia Incisional | — | UNRESOLVED | — |
| Neoplasms Malignant | Malignant Neoplasm | ALIAS | 0.90 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mesh | Procedure | — | UNRESOLVED |
| non-mesh | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- mesh
- description
- In these patients we will do sublay/interoblique repair for prevention of stoma-site hernias using a polypropylene mesh.
- interventionNames
- Procedure: mesh
- type
- ACTIVE_COMPARATOR
- label
- non-mesh
- description
- In these patients we will close the stoma with standard layered ligature suturing of the abdominal wall without mesh implantation.
- interventionNames
- Procedure: non-mesh
Primary outcomes (1)
- measure
- hernia rate
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * Absence of distant metastases (M0) * ECOG (Eastern Cooperative Oncology Group) status 0-2 * completed course of adjuvant treatment * Absence of acute inflammatory parastomal complications * Integrity of colorectal anastomosis Exclusion Criteria: * Inability to obtain consent to participate * Synchronous and metachronous malignant neoplasms * Clinically significant diseases of the cardiovascular system, liver, kidney, central nervous system * Parastomal inflammation and other conditions that increase the risk of postoperative complications * Pregnancy * HIV infection
References
Publications (0)
Data not yet available