Chimney Trial: study protocol for a randomized controlled trial
Autor: | Pasi Ohtonen, Jyrki Kössi, Maziar Nikberg, Elisa Mäkäräinen-Uhlbäck, Tero Rautio, Heikki Wiik |
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Přispěvatelé: | HYKS erva, Päijät-Häme Welfare Consortium |
Rok vydání: | 2019 |
Předmět: |
medicine.medical_specialty
medicine.medical_treatment Medicine (miscellaneous) PRIMARY STOMA FORMATION 030230 surgery law.invention Study Protocol 03 medical and health sciences Indirect costs 0302 clinical medicine Randomized controlled trial Quality of life law Multicenter trial Colostomy Abdominoperineal resection medicine Humans Single-Blind Method Pharmacology (medical) Prospective Studies Parastomal hernia prevention PROSTHETIC MESH RECTAL-CANCER METAANALYSIS PREVENT PARASTOMAL HERNIA Randomized Controlled Trials as Topic Protocol (science) lcsh:R5-920 Rectal Neoplasms business.industry Incidence (epidemiology) PROPHYLACTIC MESH Surgical Mesh 3126 Surgery anesthesiology intensive care radiology Hernia Abdominal 3. Good health Surgery Research Design PLACEMENT 030220 oncology & carcinogenesis Rectal cancer treatment lcsh:Medicine (General) business |
Zdroj: | Trials Trials, Vol 20, Iss 1, Pp 1-9 (2019) |
ISSN: | 1745-6215 |
Popis: | Background Parastomal 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/design The 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. Discussion The Chimney Trial aims to provide level-I evidence on PSH prevention. Trial registration ClinicalTrials.gov, ID: NCT03799939. Registered on 10 January 2019 |
Databáze: | OpenAIRE |
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