Stoma Hernia Intraperitoneal Full-Thickness Skin

Parastomal Hernia Clinical Trial

— SHIFT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03667287
• Other study ID #: 2017-251-31M
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2018
• Source: Umeå University
• Contact: Viktor Holmdahl, MD
• Phone: +4690 785 00 00
• Email: viktor.holmdahl[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Parastomal Hernia

Intervention

Procedure:
• Repair of parastomal hernia
Surgical repair of symptomatic parastomal hernia.

Locations

Country	Name	City	State
Sweden	Sunderby Hospital	Luleå	Norrbotten
Sweden	University Hospital of Umeå	Umeå	Västerbotten

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Recurrence	Parastomal hernia recurrence measured clinically, with stomal ultrasound and/or computerized tomography.	3, 12 and 36 months
Secondary	Pain - VHPQ	All subjects will complete Ventral Hernia Pain Questionaire (VHPQ) to assess and compare pre- and postoperative pain.	3, 12 and 36 months.
Secondary	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.
Secondary	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.
Secondary	Abdominal strength	Strength of the abdomino-lumbar girdle measured in Biodex-4.	12 and 36 months.
Secondary	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.
Secondary	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
Secondary	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