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Stoma Hernia Intraperitoneal Full-Thickness Skin (SHIFT)

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ClinicalTrials.gov Identifier: NCT03667287
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Umeå University

Study Description
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Brief Summary:
This is a prospective randomized study to compare surgical methods for the repair of parastomal hernia.

Condition or disease Intervention/treatment Phase
Parastomal Hernia Procedure: Repair of parastomal hernia Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Full-thickness Skin vs. Synthetic Mesh in the Repair of Parastomal Hernia
Actual Study Start Date : January 23, 2018
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Full-thickness skin graft
Repair of parastomal hernia with full-thickness skin graft, placed intraperitoneally, as reinforcement.
 Procedure: Repair of parastomal hernia
Surgical repair of symptomatic parastomal hernia.
Active Comparator: Synthethic mesh
Repair of parastomal hernia with best available conventional method, using synthetic mesh material as reinforcement
 Procedure: Repair of parastomal hernia
Surgical repair of symptomatic parastomal hernia.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of complications at 3 months [ Time Frame: 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 Outcome Measures :
  1. Recurrence [ Time Frame: 3, 12 and 36 months ]
    Parastomal hernia recurrence measured clinically, with stomal ultrasound and/or computerized tomography.

  2. Pain - VHPQ [ Time Frame: 3, 12 and 36 months. ]
    All subjects will complete Ventral Hernia Pain Questionaire (VHPQ) to assess and compare pre- and postoperative pain.

  3. QoL - EORTC CR29 [ Time Frame: 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.

  4. QoL - EORTC C30 [ Time Frame: 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.

  5. Abdominal strength [ Time Frame: 12 and 36 months. ]
    Strength of the abdomino-lumbar girdle measured in Biodex-4.

  6. Health economics [ Time Frame: 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.

  7. Rate of complications at 12 months [ Time Frame: 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.

  8. Rate of complications at 36 months [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667287


Contacts
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Contact: Viktor Holmdahl, MD +4690 785 00 00 viktor.holmdahl@umu.se

Locations
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Sweden
Sunderby Hospital Not yet recruiting
Luleå, Norrbotten, Sweden, 95442
University Hospital of Umeå Recruiting
Umeå, Västerbotten, Sweden, 90185
Sponsors and Collaborators
Umeå University
Investigators
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Principal Investigator: Karin Strigård, PhD Umeå University, Department of Surgical and Perioperative sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT03667287    
Other Study ID Numbers: 2017-251-31M
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical