NCT03799939

Chimney Trial of Parastomal Hernia Prevention

Chimney Trial - Randomized, Controlled, Multi Center Trial of Parastomal Hernia Prevention

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: University of Oulu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Chimney trial is designed to compare the effectiveness and safety of specifically designated polyvinylidene fluoride mesh (PVDF, Dynamesh IPST) to controls in a multi center, randomized setting.

Detailed description

The European Hernia Society recommends the use of prophylactic mesh when permanent colostomy is made. The results of previous trials using keyhole technique are partially unsatisfactory. Specifically designed PVDF mesh used in this trial showed promising results in previous small trial. Chimney trial is designed to compare the effectiveness and safety of mesh group to controls operated with no preventive mesh in parastomal hernia prevention after laparoscopic or robotic-assisted abdominoperineal resection or low Haartman's procedure for rectal adenocarcinoma.

Conditions

• Parastomal Hernia
• Rectal Adenocarcinoma
• Abdominoperineal Resection

Interventions

Type	Name	Description
DEVICE	Intervention group	Polyvinylidene fluoride mesh (Dynamesh IPST) is used on intraperitoneal onlay position to prevent parastomal hernia.

Timeline

• Start date: 2019-02-05
• Primary completion: 2022-08-30
• Completion: 2026-07-01
• First posted: 2019-01-10
• Last updated: 2024-02-01

Locations

7 sites across 2 countries: Finland, Sweden