NCT05627284

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stoma Site Incisional Hernia

Interventions

Type	Name	Description
PROCEDURE	Stoma reversal with bio-mesh placement	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.

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-09-30
• Completion: 2025-09-30
• First posted: 2022-11-25
• Last updated: 2022-11-25

Locations

1 site across 1 country: China