A Prospective Clinical Trial of Colostomy-replacement Combined With Bio-mesh Placement in the Prevention of SSIH

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Clinical Trial of Colostomy-replacement Combined With Bio-mesh Placement in the Prevention of SSIH

Conditions
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Stoma Site Incisional Hernia

Intervention / Treatment
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* Procedure: Stoma reversal with bio-mesh placement


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stoma reversal with bio-mesh placement<br> | Procedure: Stoma reversal with bio-mesh placement<br>* Patients will receive stoma reversal. During the surgery, a bio-mesh is placed beyond the peritoneum on the surgical site to strengthen the abdominal wall.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stoma site incisional hernia | Hernia occurs on the primary stoma site | one-year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stoma Site Incisional Hernia, Colon cancer