This is a prospective randomized study to compare surgical methods for the repair of parastomal hernia.
Parastomal hernia is a common complication to a stoma which can cause considerable suffering for the patient. The conventional methods of repair available today have disappointing results with high recurrence rates and serious complications. Some of the complications can be related to the introduction of foreign material into the abdominal wall. The investigators hypothesis is that the use of autologous full-thickness skin graft as reinforcement material can offer an alternative with fewer complications and recurrences. Patients with symptomatic parastomal hernia will be included in a prospective randomized multicenter study comparing reinforcement with conventional synthetic mesh (with the best available technique today), to full thickness skin grafts placed in an intraperitoneal position. The intervention will be blinded to the participants, nursing staff and the follow-up staff. The participants will be followed up at 3, 12 and 36 months monitoring complications, recurrences, quality of life, strength of the abdomino-lumbar girdle and calculations will be done on the health economics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
Surgical repair of symptomatic parastomal hernia.
Sunderby Hospital
Luleå, Norrbotten County, Sweden
NOT_YET_RECRUITINGUniversity Hospital of Umeå
Umeå, Västerbotten County, Sweden
RECRUITINGRate of complications at 3 months
Complications will be assessed over a 3 year period of regular follow-up by an objective surgeon who is unaware of which surgical method which was used. Eventual complications may include infection, bleeding, seroma and fistula formation.
Time frame: 3 month post-operative clinical follow-up
Recurrence
Parastomal hernia recurrence measured clinically, with stomal ultrasound and/or computerized tomography.
Time frame: 3, 12 and 36 months
Pain - VHPQ
All subjects will complete Ventral Hernia Pain Questionaire (VHPQ) to assess and compare pre- and postoperative pain.
Time frame: 3, 12 and 36 months.
QoL - EORTC CR29
All subject will complete European Organisation for Research and Treatment of Cancer questionnaire module for colorectal cancer (EORTC CR29) as a complement to EORTC C30, to assess and compare pre- and postoperative quality of life.
Time frame: 3, 12 and 36 months.
QoL - EORTC C30
All subject will complete European Organisation for Research and Treatment of Cancer core quality of life questionnaire (EORTC CR30) to assess and compare pre- and postoperative quality of life.
Time frame: 3, 12 and 36 months.
Abdominal strength
Strength of the abdomino-lumbar girdle measured in Biodex-4.
Time frame: 12 and 36 months.
Health economics
Cost-effectiveness of the separate procedures. The total cost of each method will be calculated from the hospital economic systems including duration of surgery, cost of operating time and equipment as well as duration and cost of anesthesia.
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Time frame: 12 and 36 months.
Rate of complications at 12 months
Complications will be assessed over a 3 year period of regular follow-up by an objective surgeon who is unaware of which surgical method which was used. Eventual complications may include infection, bleeding, seroma and fistula formation.
Time frame: 12 month post-operative clinical follow-up
Rate of complications at 36 months
Complications will be assessed over a 3 year period of regular follow-up by an objective surgeon who is unaware of which surgical method which was used. Eventual complications may include infection, bleeding, seroma and fistula formation.
Time frame: 36 month post-operative clinical follow-up