Abstract
BackgroundParastomal hernias (PSHs) are common, troubling the lives of people with permanent colostomy. In previous studies, retromuscular keyhole mesh placement has been the most-used technique for PSH prevention but results have been controversial. Additionally, surgical treatment of PSHs is associated with a high rate of complications and recurrences. Therefore, it is crucial to find the most effective way to prevent PSHs in the first place without an increased risk of complications. Due to a lack of adequate research, there is no clear evidence or recommendations on which mesh or technique is best to prevent PSHs.Methods/designThe Chimney Trial is a Nordic, prospective, randomized controlled, multicenter trial designed to compare the feasibility and the potential benefits of specifically designed, intra-abdominal onlay mesh (DynaMesh®-Parastomal, FEG Textiltechnik GmbH, Aachen, Germany) against controls with permanent colostomy without mesh.The primary outcome of the Chimney Trial is the incidence of a PSH detected by a computerized tomography (CT) scan at 12-month follow-up. Secondary outcomes are the rate of clinically detected PSHs, surgical-site infection as defined by the Centers for Disease Control and Prevention (CDC), complications as defined by the Clavien-Dindo classification, the reoperation rate, operative time, length of stay, quality of life as measured by the RAND-36 survey and colostomy impact score, and both direct and indirect costs. For each group, 102 patients were enrolled at attending hospitals and randomized at a ratio of 1:1 by browser-based software to receive a preventive mesh or a conventional colostomy without a mesh. Patients will be followed for 1 month and at 1, 3, and 5 years after the operation for long-term results and complications.DiscussionThe Chimney Trial aims to provide level-I evidence on PSH prevention.Trial registrationClinicalTrials.gov, ID: NCT03799939. Registered on 10 January 2019
Highlights
Abdominoperineal resection (APR) with permanent endcolostomy formation was introduced in the late twentieth century as a surgical method to treat distal rectal cancer in order to decrease the previously high incidence of local recurrence [1, 2]
Mäkäräinen-Uhlbäck et al Trials (2019) 20:652 focus should be on prevention, which is recommended in guidelines by the European Hernia Society [11]
If the Parastomal hernia (PSH) rate is increased by more than 35% in the control group compared with the PVDF-mesh group or there are 10% or more complications defined by ClavienDindo classification 3B in either group compared with the other group, the trial will be terminated as unethical to continue
Summary
Background and rationale Abdominoperineal resection (APR) with permanent endcolostomy formation was introduced in the late twentieth century as a surgical method to treat distal rectal cancer in order to decrease the previously high incidence of local recurrence [1, 2]. The reported incidence of parastomal hernias (PSHs) with permanent end colostomy rises to 81% after longterm follow-up [5]. Parastomal hernias (PSHs) are common, troubling the lives of people with permanent colostomy. It is crucial to find the most effective way to prevent PSHs in the first place without an increased risk of complications. Due to a lack of adequate research, there is no clear evidence or recommendations on which mesh or technique is best to prevent PSHs
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