Clinical trial · Interventional
A Prospective Clinical Trial of Colostomy-replacement Combined With Bio-mesh Placement in the Prevention of SSIH
- 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 explore the safety and effectiveness of stoma reversal combining bio-mesh placement in patients with high risk of stoma site incisional hernia (SSIH). The main questions it aims to answer are: * Whether bio-mesh placement is safe for patients with a high risk of SSIH. * Whether stoma reversal combining bio-mesh placement is a preventive strategy for patients with high risk of SSIH. * Whether stoma reversal combining bio-mesh placement will trigger other complications. Participants who are eligible and are enrolled in this study will receive stoma reversal combining bio-mesh placement surgery. After that, they will be followed up for one year to evaluate the occurrence of SSIH and other complications.
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 |
|---|---|---|---|
| Stoma Site Incisional Hernia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stoma reversal with bio-mesh placement | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stoma reversal with bio-mesh placement
- interventionNames
- Procedure: Stoma reversal with bio-mesh placement
Primary outcomes (1)
- measure
- stoma site incisional hernia
- timeFrame
- one-year after surgery
- description
- Hernia occurs on the primary stoma site
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 18-75 years old; * Patients should have colonic prophylactic stoma and have not received reversal yet; * There are no obvious signs of tumor recurrence or metastasis in tumor patients before stoma resection; * No serious underlying diseases, can tolerate general anesthesia surgery * Preoperative ECOG (Eastern Cooperative Oncology Group) physical status score 0/1; * Preoperative ASA (American Society of Anesthesiologists) grade I-III; * Without vital organs function failure; * All patients and their families signed informed consent before surgery. Exclusion Criteria: * Incapacitated persons; * With a history of other types of hernia; * Those who have had hernia mesh implantation before; * Those who are allergic to bio-mesh or their components before; * Combined with other surgeries; * Severe mental illness; * Severe respiratory disease; * Severe liver and kidney insufficiency; * Those who have absolute contraindications to surgery; * Suffering from severe bleeding disorders or obvious abnormal coagulation function; * History of unstable angina or myocardial infarction within 6 months; * History of cerebral infarction or cerebral hemorrhage within 6 months; * Continuous intravenous application of glucocorticoid within 1 month; * The patient has participated or is participating in other clinical studies (within 6 months).
References
Publications (0)
Data not yet available