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Preloop trial: study protocol for a randomized controlled trial
Elisa Mäkäräinen-Uhlbäck1, Heikki Wiik2, Jyrki Kössi3
1Oulu University Hospital, PL 10, 90029 OYS, Oulu, Finland. Elisa.makarainen-uhlback@ppshp.fi.
Trials
|November 11, 2018
Summary
This pilot study compares synthetic mesh and biological implants for preventing incisional hernias after loop ileostomy closure. Results will guide optimal mesh choice for hernia prevention.
Area of Science:
- Surgical Oncology
- Hernia Repair
- Mesh Implants
Background:
- Temporary loop ileostomy closure can lead to incisional hernias, requiring further repair.
- Current research on preventing these hernias is limited, with no comparative studies on different mesh types.
- The Preloop trial addresses this gap by comparing synthetic and biological meshes.
Purpose of the Study:
- To compare the safety and efficacy of synthetic mesh versus biological implants for preventing incisional hernias after loop ileostomy closure.
- To evaluate infection rates, hernia incidence, and other complications associated with mesh use.
- To provide evidence for optimal mesh selection in preventing incisional hernias.
Main Methods:
- Prospective, randomized, controlled, multicenter trial (Preloop trial, NCT03445936).
- Comparison of synthetic mesh (Parietene Macro™) and biological implants (Permacol™) in a retromuscular sublay position.
- 100 patients randomized 1:1; primary endpoints: infection at 30 days and hernia incidence at 10 months.
Main Results:
- This is a pilot trial, results are pending.
- The study aims to provide novel evidence on safety and efficiency.
- Hypothesis: Synthetic mesh is economical, safe, and effective for hernia prevention.
Conclusions:
- This pilot trial will offer new insights into mesh use for preventing incisional hernias post-ileostomy closure.
- Findings will inform clinical practice regarding the choice between synthetic and biological meshes.
- The study hypothesizes comparable safety and efficacy, with synthetic mesh being more economical.
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