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

Not Applicable

Recruiting

• Conditions: Stoma Site Incisional Hernia
• Interventions: Procedure: Stoma reversal with bio-mesh placement

• Registration Number: NCT05627284
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study Start: 2022-10-01
• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-16
• Last Update Submitted: 2022-11-16
• Study First Posted: 2022-11-25
• Last Update Posted: 2022-11-25
• Primary Completion: 2024-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stoma reversal with bio-mesh placement	Stoma reversal with bio-mesh placement	-

Primary Outcome Measures

Name	Time	Method
stoma site incisional hernia	one-year after surgery	Hernia occurs on the primary stoma site

Trial Locations

Locations (1)

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China