Ventral HerniaNCT01413412
Full-thickness Skin vs. Synthetic Mesh in the Repair of Large Incisional Hernia
A study testing Ventral hernia repair using full thickness skin graft and Ventral hernia repair using mesh in people with Ventral Hernia and Postoperative Pain, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This is a prospective randomized study to compare surgical methods for the repair of large abdominal hernia. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ventral Hernia, Postoperative Pain
- What is being tested?
- Ventral hernia repair using full thickness skin graft and Ventral hernia repair using mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2009to Dec 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ventral hernia > 10 centimeters, abdominal wall pain or discomfort, desire hernia repair.
Who cannot join
- < 18 years of age, ongoing pregnancy or nursing, ongoing immunosuppressive treatment,ongoing smoking.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Full-thickness Skin vs. Synthetic Mesh in the Repair of Large Incisional Hernia - a Prospective Randomized Controlled Study
This is a prospective randomized study to compare surgical methods for the repair of large abdominal hernia.
Read the detailed description
Patients with giant (>10 cm in diameter) abdominal wall hernia are included in a prospective randomized study comparing conventional mesh repair with the best possible method to onlay full thickness skin grafts.
- Conditions
- Ventral Hernia, Postoperative Pain
- Being tested
- Ventral hernia repair using full thickness skin graft, Ventral hernia repair using mesh
- Keywords
- Ventral Hernia, Postoperative Pain, Ventral Hernia Pain Questionnaire, Postoperative Abdominal wall and muscle function, Biodex
- Medical subject headings
- Hernia, Ventral, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventral hernia repair using full thickness skin graftProcedure or surgery
25 patients
Ventral hernia repair using meshProcedure or surgery
25 patients
| Study group | Role | What they receive |
|---|---|---|
| Hernia repair using full-thickness skin graft | Experimental | 25 patients Receives: Procedure: Ventral hernia repair using full thickness skin graft |
| Hernia repair using Mesh | Experimental | 25 patients Receives: Procedure: Ventral hernia repair using mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complication
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, 1 year and 3 year post-operative clinical follow-up
Secondary outcomes (2)
Ventral Hernia Pain Questionnaire (VHPQ)
All subjects will complete the VHPQ which will be used to assess their pre- and postoperative pain.
Measured: 1 year period of follow-up
Abdominal wall function
All subjects will undergo testing of abdominal wall function and strength using the Biodex.
Measured: 3 year period of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startDec 2009
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonard Clay, Karolinska Institutet
- Investigators
- Karin Strigård, MD, Study director, Karolinska Institute CLINTECLeonard Clay, MD, Principal investigator, Karolinska Institute CLINTECUlf Gunnarsson, MD, Study chair, Karolinska Institute CLINTEC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413412
- Sponsor's protocol ID
- 2009/227-31/3
- Status last verified
- Sep 2015
- First submitted
- 9 Aug 2011
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Holmdahl V, Stark B, Clay L, Gunnarsson U, Strigard K. Long-term follow-up of full-thickness skin grafting in giant incisional hernia repair: a randomised controlled trial. Hernia. 2022 Apr;26(2):473-479. doi: 10.1007/s10029-021-02544-z. Epub 2021 Dec 14.
PubMed 34905143Clay L, Stark B, Gunnarsson U, Strigard K. Full-thickness skin graft vs. synthetic mesh in the repair of giant incisional hernia: a randomized controlled multicenter study. Hernia. 2018 Apr;22(2):325-332. doi: 10.1007/s10029-017-1712-x. Epub 2017 Dec 15.
PubMed 29247365
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. 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 Large Incisional Hernia - a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01413412
- Acronym / sponsor ID
- 2009/227-31/3
- Conditions
- Ventral Hernia, Postoperative Pain
- Keywords
- Ventral Hernia, Postoperative Pain, Ventral Hernia Pain Questionnaire, Postoperative Abdominal wall and muscle function, Biodex
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 Aug 2011 (estimated)
- 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 large abdominal hernia.
Detailed description
Patients with giant (>10 cm in diameter) abdominal wall hernia are included in a prospective randomized study comparing conventional mesh repair with the best possible method to onlay full thickness skin grafts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hernia repair using full-thickness skin graft | Experimental | Procedure: Ventral hernia repair using full thickness skin graft25 patients |
| Hernia repair using Mesh | Experimental | Procedure: Ventral hernia repair using mesh25 patients |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ventral hernia > 10 centimeters, abdominal wall pain or discomfort, desire hernia repair.
Key exclusion criteria (1 listed)
- < 18 years of age, ongoing pregnancy or nursing, ongoing immunosuppressive treatment,ongoing smoking.
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 |
|---|---|---|
| Ventral hernia repair using full thickness skin graft25 patients | Procedure or surgery | Hernia repair using full-thickness skin graft |
| Ventral hernia repair using mesh25 patients | Procedure or surgery | Hernia repair using Mesh |
Primary outcome
Rate of complication
Time frame: 3 month, 1 year and 3 year 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.
2 secondary outcomes
Ventral Hernia Pain Questionnaire (VHPQ)
Time frame: 1 year period of follow-up
Abdominal wall function
Time frame: 3 year period of follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2015.
- Derived from this study: PubMed 34905143Holmdahl V, Stark B, Clay L, Gunnarsson U, Strigard K. Long-term follow-up of full-thickness skin grafting in giant incisional hernia repair: a randomised controlled trial. Hernia. 2022 Apr;26(2):473-479. doi: 10.1007/s10029-021-02544-z. Epub 2021 Dec 14.
- Derived from this study: PubMed 29247365Clay L, Stark B, Gunnarsson U, Strigard K. Full-thickness skin graft vs. synthetic mesh in the repair of giant incisional hernia: a randomized controlled multicenter study. Hernia. 2018 Apr;22(2):325-332. doi: 10.1007/s10029-017-1712-x. Epub 2017 Dec 15.
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Ventral Incisional Hernia
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, MD study director
Karolinska Institute CLINTEC
Leonard Clay, MD principal investigator
Karolinska Institute CLINTEC
Ulf Gunnarsson, MD study chair
Karolinska Institute CLINTEC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventral hernia repair using full thickness skin graft and Ventral hernia repair using mesh in people with Ventral Hernia and Postoperative Pain, run by Karolinska Institutet at 1 site 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 1 inclusion and 1 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 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complication (time frame: 3 month, 1 year and 3 year 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 NCT01413412, which also lists 2 linked publications.
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 29 Sep 2015.