Chimney trial is designed to compare the effectiveness and safety of specifically designated polyvinylidene fluoride mesh (PVDF, Dynamesh IPST) to controls in a multi center, randomized setting.
The European Hernia Society recommends the use of prophylactic mesh when permanent colostomy is made. The results of previous trials using keyhole technique are partially unsatisfactory. Specifically designed PVDF mesh used in this trial showed promising results in previous small trial. Chimney trial is designed to compare the effectiveness and safety of mesh group to controls operated with no preventive mesh in parastomal hernia prevention after laparoscopic or robotic-assisted abdominoperineal resection or low Haartman's procedure for rectal adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
141
Polyvinylidene fluoride mesh (Dynamesh IPST) is used on intraperitoneal onlay position to prevent parastomal hernia.
Helsinki University Hospital
Helsinki, Finland
Keski-Suomi Central Hospital
Jyväskylä, Finland
Oulu University Hospital
Oulu, Finland
Seinäjoki Central Hospital
Seinäjoki, Finland
Incidence of parastomal hernia
Incidence of parastomal hernia at 12 months follow up
Time frame: 12 months
Incidence of parastomal hernia at long term follow up
Incidence of parastomal hernia during 5 years of follow up
Time frame: 5 years
Surgical site infection rate
Surgical site infections measured by Clavien-Dindo Classification
Time frame: 30 days
Complications
Complications measured by Clavien-Dindo Classification
Time frame: 30 days
Stoma related complications
Stoma related complications measured by Clavien-Dindo Classification
Time frame: 5 years
Reoperation rate
Need for reoperations
Time frame: 5 years
Operative time
Operative time
Time frame: 1 day
Length of stay
Length of stay at the hospital
Time frame: 30 days
Rand 36 quality of life
Quality of life measured by Rand-36 quality of life questionnaire
Time frame: 5 years
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Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
Maziar Nikberg
Västerås, Sweden
Quality of life measured by Colostomy impact score
Quality of life measured by Colostomy impact score
Time frame: 5 years
Medico-economic substudy
Medico-economic substudy including both short and long term costs included in both groups
Time frame: 5 years
Radiological substudy of stoma distance
Distance of stoma from midline defined by umbilicus
Time frame: 3 years
Radiological substudy of adipose tissue thickness
Thickness of adipose tissue on computer tomography scan on contralateral site of stoma
Time frame: 3 years