Clinical trial NCT03667287: Stoma Hernia Intraperitoneal Full-Thickness Skin
Official title: Full-thickness Skin vs. Synthetic Mesh in the Repair of Parastomal Hernia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parastomal Hernia
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of complications at 3 months
timeFrame: 3 month post-operative clinical follow-up
Secondary outcomes:
measure: Recurrence
timeFrame: 3, 12 and 36 months
measure: Pain - VHPQ
timeFrame: 3, 12 and 36 months.
measure: QoL - EORTC CR29
timeFrame: 3, 12 and 36 months.
measure: QoL - EORTC C30
timeFrame: 3, 12 and 36 months.
measure: Abdominal strength
timeFrame: 12 and 36 months.
measure: Health economics
timeFrame: 12 and 36 months.
measure: Rate of complications at 12 months
timeFrame: 12 month post-operative clinical follow-up
measure: Rate of complications at 36 months
timeFrame: 36 month post-operative clinical follow-up
Other outcomes:
Locations:
city: Luleå
country: Sweden
facility: Sunderby Hospital
state: Norrbotten
city: Umeå
country: Sweden
facility: University Hospital of Umeå
state: Västerbotten
Study officials:
affiliation: Umeå University, Department of Surgical and Perioperative sciences
name: Karin Strigård, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.