Parastomal HerniaSHIFTNCT03667287
Stoma Hernia Intraperitoneal Full-Thickness Skin
A study testing Repair of parastomal hernia in people with Parastomal Hernia, run by Umeå University at 2 sites in Sweden.
Trial summary
This is a prospective randomized study to compare surgical methods for the repair of parastomal hernia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parastomal Hernia
- What is being tested?
- Repair of parastomal hernia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesSweden
- Study dates
- 23 Jan 2018to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites, 2 recruiting
- Not yet recruiting
Sunderby Hospital
Luleå, Norrbotten County, 95442
- Recruiting
University Hospital of Umeå
Umeå, Västerbotten County, 90185
About this study
Official title: 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.
Read the 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.
- Conditions
- Parastomal Hernia
- Being tested
- Repair of parastomal hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repair of parastomal herniaProcedure or surgery
Surgical repair of symptomatic parastomal hernia.
| Study group | Role | What they receive |
|---|---|---|
| Full-thickness skin graft | Experimental | Repair of parastomal hernia with full-thickness skin graft, placed intraperitoneally, as reinforcement. Receives: Procedure: Repair of parastomal hernia |
| Synthethic mesh | Active comparator | Repair of parastomal hernia with best available conventional method, using synthetic mesh material as reinforcement Receives: Procedure: Repair of parastomal hernia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 month post-operative clinical follow-up
Secondary outcomes (8)
Recurrence
Parastomal hernia recurrence measured clinically, with stomal ultrasound and/or computerized tomography.
Measured: 3, 12 and 36 months
Pain - VHPQ
All subjects will complete Ventral Hernia Pain Questionaire (VHPQ) to assess and compare pre- and postoperative pain.
Measured: 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.
Measured: 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.
Measured: 3, 12 and 36 months.
Abdominal strength
Strength of the abdomino-lumbar girdle measured in Biodex-4.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 36 month post-operative clinical follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start23 Jan 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parastomal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karin Strigård, PhD, Principal investigator, Umeå University, Department of Surgical and Perioperative sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667287
- Sponsor's protocol ID
- 2017-251-31M
- Acronym
- SHIFT
- Status last verified
- Aug 2018
- First submitted
- 29 Aug 2018
- Last updated
- 1 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34876195
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full-thickness Skin vs. Synthetic Mesh in the Repair of Parastomal Hernia
- ClinicalTrials.gov ID
- NCT03667287
- Acronym / sponsor ID
- SHIFT / 2017-251-31M
- Conditions
- Parastomal Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full-thickness skin graft | Experimental | Procedure: Repair of parastomal herniaRepair of parastomal hernia with full-thickness skin graft, placed intraperitoneally, as reinforcement. |
| Synthethic mesh | Active comparator | Procedure: Repair of parastomal herniaRepair of parastomal hernia with best available conventional method, using synthetic mesh material as reinforcement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repair of parastomal herniaSurgical repair of symptomatic parastomal hernia. | Procedure or surgery | Full-thickness skin graft, Synthethic mesh |
Primary outcome
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.
8 secondary outcomes
Recurrence
Time frame: 3, 12 and 36 months
Pain - VHPQ
Time frame: 3, 12 and 36 months.
QoL - EORTC CR29
Time frame: 3, 12 and 36 months.
QoL - EORTC C30
Time frame: 3, 12 and 36 months.
Abdominal strength
Time frame: 12 and 36 months.
Health economics
Time frame: 12 and 36 months.
Rate of complications at 12 months
Time frame: 12 month post-operative clinical follow-up
Rate of complications at 36 months
Time frame: 36 month post-operative clinical follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Derived from this study: PubMed 34876195Holmdahl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Strigård, PhD principal investigator
Umeå University, Department of Surgical and Perioperative sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repair of parastomal hernia in people with Parastomal Hernia, run by Umeå University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Viktor Holmdahl, MD (+4690 785 00 00, viktor.holmdahl@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complications at 3 months (time frame: 3 month post-operative clinical follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03667287, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.