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Chimney Trial: study protocol for a randomized controlled trial
Elisa Mäkäräinen-Uhlbäck1, Heikki Wiik2, Jyrki Kössi3
1Oulu University Hospital, PL 21, 90029, OYS, Finland. elisa.makarainen-uhlback@ppshp.fi.
Trials
|November 30, 2019
Summary
The Chimney Trial investigates using a specialized intra-abdominal mesh to prevent parastomal hernias (PSHs) in patients with permanent colostomies. This study aims to provide high-level evidence on the most effective PSH prevention method.
Area of Science:
- Surgical innovation and clinical trials
- Gastrointestinal surgery outcomes
- Hernia prevention strategies
Background:
- Parastomal hernias (PSHs) are a frequent complication for individuals with permanent colostomies.
- Current retromuscular keyhole mesh techniques for PSH prevention have yielded controversial results.
- Surgical repair of PSHs is associated with significant complication and recurrence rates, highlighting the need for effective prevention.
Purpose of the Study:
- To evaluate the efficacy of an intra-abdominal onlay mesh in preventing PSHs compared to conventional colostomy without mesh.
- To provide level-I evidence for PSH prevention strategies.
Main Methods:
- The Nordic, prospective, randomized controlled multicenter Chimney Trial enrolled 204 patients with permanent colostomies, randomized 1:1 to receive either a preventive mesh or no mesh.
- The primary outcome is the incidence of PSH detected by CT scan at 12 months.
- Secondary outcomes include clinical PSH detection, surgical site infections, complications (Clavien-Dindo), reoperation rates, operative time, length of stay, quality of life, and costs, with follow-up at 1, 3, and 5 years.
Main Results:
- This section is not available in the provided abstract.
Conclusions:
- The Chimney Trial is designed to generate robust, level-I evidence to guide clinical practice in parastomal hernia prevention.
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