Chimney Trial: study protocol for a randomized controlled trial

Autor: Pasi Ohtonen, Jyrki Kössi, Maziar Nikberg, Elisa Mäkäräinen-Uhlbäck, Tero Rautio, Heikki Wiik
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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