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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full-thickness skin graft | Experimental | Repair of parastomal hernia with full-thickness skin graft, placed intraperitoneally, as reinforcement. |
|
| Synthethic mesh | Active Comparator | Repair of parastomal hernia with best available conventional method, using synthetic mesh material as reinforcement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repair of parastomal hernia | Procedure | Surgical repair of symptomatic parastomal hernia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate 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. | 3 month post-operative clinical follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence | Parastomal hernia recurrence measured clinically, with stomal ultrasound and/or computerized tomography. | 3, 12 and 36 months |
| Pain - VHPQ | All subjects will complete Ventral Hernia Pain Questionaire (VHPQ) to assess and compare pre- and postoperative pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Viktor Holmdahl, MD | Contact | +4690 785 00 00 | viktor.holmdahl@umu.se |
| Name | Affiliation | Role |
|---|---|---|
| Karin Strigård, PhD | Umeå University, Department of Surgical and Perioperative sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunderby Hospital | Not yet recruiting | Luleå | Norrbotten County | 95442 | Sweden | |
| University Hospital of Umeå |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34876195 | Derived | Holmdahl V, Gunnarsson U, Strigard K. Autologous full-thickness skin graft as reinforcement in parastomal hernia repair: a randomised controlled trial. Trials. 2021 Dec 7;22(1):891. doi: 10.1186/s13063-021-05884-4. |
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| 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. | 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. | 3, 12 and 36 months. |
| Abdominal strength | Strength of the abdomino-lumbar girdle measured in Biodex-4. | 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. | 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. | 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. | 36 month post-operative clinical follow-up |
| Recruiting |
| Umeå |
| Västerbotten County |
| 90185 |
| Sweden |