Stoma Hernia Intraperitoneal Full-Thickness Skin (SHIFT)

Full-thickness Skin vs. Synthetic Mesh in the Repair of Parastomal Hernia

This is a prospective randomized study to compare surgical methods for the repair of parastomal hernia.

Study Overview

• Status: Recruiting
• Conditions: Parastomal Hernia
• Intervention / Treatment: Procedure: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Viktor Holmdahl, MD; Phone Number: +4690 785 00 00; Email: viktor.holmdahl@umu.se

Study Locations

• Sweden
  • Norrbotten
    • Luleå, Norrbotten, Sweden, 95442
      • Not yet recruiting
      • Sunderby Hospital
  • Västerbotten
    • Umeå, Västerbotten, Sweden, 90185
      • Recruiting
      • University Hospital of Umeå

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Umeå University
• Investigators: Principal Investigator: Karin Strigård, PhD, Umeå University, Department of Surgical and Perioperative Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 23, 2018
• Primary Completion (ANTICIPATED): December 31, 2025
• Study Completion (ANTICIPATED): December 31, 2025

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (ACTUAL): September 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 1, 2019
• Last Update Submitted That Met QC Criteria: April 29, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: 2017-251-31M

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No