Parastomal Hernia
Conditions
Brief summary
This is a prospective randomized study to compare surgical methods for the repair of parastomal hernia.
Detailed description
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.
Interventions
PROCEDURERepair of parastomal hernia
Surgical repair of symptomatic parastomal hernia.
Sponsors
Umeå University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Colo-, ileo- or urostomy * Parastomal hernia diagnosed with intrastomal ultrasound and/or CT * Symptoms from the parastomal hernia requiring surgical intervention * Informed consent * \>18 years of age * Sufficient knowledge in the Swedish language so that questionnaires can be answered
Exclusion criteria
* Cognitive impairment unabling compliance to post-operative prescriptions and/or answering questionnaires * Insufficient amount of good quality skin suitable for transplantation * Expected high donor-site morbidity * Fistula/e adjacent to stoma * Mb Crohn
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complications at 3 months | 3 month post-operative clinical follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain - VHPQ | 3, 12 and 36 months. | All subjects will complete Ventral Hernia Pain Questionaire (VHPQ) to assess and compare pre- and postoperative pain. |
| QoL - EORTC CR29 | 3, 12 and 36 months. | 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. |
| QoL - EORTC C30 | 3, 12 and 36 months. | 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. |
| Recurrence | 3, 12 and 36 months | Parastomal hernia recurrence measured clinically, with stomal ultrasound and/or computerized tomography. |
| Health economics | 12 and 36 months. | 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. |
| Rate of complications at 12 months | 12 month post-operative clinical follow-up | 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. |
| Rate of complications at 36 months | 36 month post-operative clinical follow-up | 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. |
| Abdominal strength | 12 and 36 months. | Strength of the abdomino-lumbar girdle measured in Biodex-4. |
Countries
Sweden
Contacts
Primary ContactViktor Holmdahl, MD
Outcome results
None listed