Stoma Hernia Intraperitoneal Full-Thickness Skin
SHIFT
Full-thickness Skin vs. Synthetic Mesh in the Repair of Parastomal Hernia
1 other identifier
interventional
90
1 country
2
Brief Summary
This is a prospective randomized study to compare surgical methods for the repair of parastomal hernia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 23, 2018
CompletedFirst Submitted
Initial submission to the registry
August 29, 2018
CompletedFirst Posted
Study publicly available on registry
September 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedMay 1, 2019
August 1, 2018
7.9 years
August 29, 2018
April 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (8)
Recurrence
3, 12 and 36 months
Pain - VHPQ
3, 12 and 36 months.
QoL - EORTC CR29
3, 12 and 36 months.
QoL - EORTC C30
3, 12 and 36 months.
Abdominal strength
12 and 36 months.
- +3 more secondary outcomes
Study Arms (2)
Full-thickness skin graft
EXPERIMENTALRepair of parastomal hernia with full-thickness skin graft, placed intraperitoneally, as reinforcement.
Synthethic mesh
ACTIVE COMPARATORRepair of parastomal hernia with best available conventional method, using synthetic mesh material as reinforcement
Interventions
Surgical repair of symptomatic parastomal hernia.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Umeå Universitylead
Study Sites (2)
Sunderby Hospital
Luleå, Norrbotten County, 95442, Sweden
University Hospital of Umeå
Umeå, Västerbotten County, 90185, Sweden
Related Publications (1)
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.
PMID: 34876195DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Karin Strigård, PhD
Umeå University, Department of Surgical and Perioperative sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2018
First Posted
September 12, 2018
Study Start
January 23, 2018
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
May 1, 2019
Record last verified: 2018-08