Incisional HerniaPhase 3VRAMNCT00647569
Trial of Collagen Mesh for Prevention of Ventral Hernia After Surgery for Advanced Pelvic Cancer
A Phase 3 study testing Mesh repair and Conventional facial closure in people with Incisional Hernia and Pelvic Cancer, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of the present project is to investigate whether use of biological mesh at the donor site of the rotation flap in closure of the abdominal wall reduce the frequency of incisional hernia formation compared to the usual abdominal wall closure after abdominal rotation flap operation in surgery for advanced pelvic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia, Pelvic Cancer
- What is being tested?
- Mesh repair and Conventional facial closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2008to Jun 2012
- Phase
- Phase 3
- 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
- Patients operated with a vertical rectus abdominis musculocutaneus flap after abdominoperineal resection for advanced pelvic cancer.
Who cannot join
- Pre or perioperative knowledge of disseminated malignancy
- Unable to follow the control program
- Known allergy to pig
- Compromised immune defense
- Artificial heart valve or recent (< 3 months) implanted foreign body
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: Randomized Controlled Trial of Collagen Mesh for Prevention of Ventral Hernia in Patients With Vertical Rectus Abdominis Musculocutaneus Flap for Advanced Pelvic Malignancy
The aim of the present project is to investigate whether use of biological mesh at the donor site of the rotation flap in closure of the abdominal wall reduce the frequency of incisional hernia formation compared to the usual abdominal wall closure after abdominal rotation flap operation in surgery for advanced pelvic cancer.
- Conditions
- Incisional Hernia, Pelvic Cancer
- Being tested
- Mesh repair, Conventional facial closure
- Keywords
- vertical rectus abdominis musculocutaneus flap, mesh repair, salvage surgery
- Medical subject headings
- Incisional Hernia, Pelvic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesh repairProcedure or surgery
Also called Surgisis Gold Hernia repair graft
A Surgisis Gold Hernia repair graft (Cook Biotech Incorporated, West Lafayette, IN, U.S.A) is placed at the donor site of the rectus abdominis muscles used for the rotation flap before the abdominal fascia is sutured with continuous running suture.
Conventional facial closureProcedure or surgery
The abdominal facia is closed with with continuous running suture
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | No previous major abdominal surgery Receives: Procedure: Mesh repair; Procedure: Conventional facial closure |
| B | Experimental | Previous major abdominal surgery Receives: Procedure: Mesh repair; Procedure: Conventional facial closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
incisional hernia formation determined by CT scan 1 year postoperative
Measured: 1 year postoperative
Secondary outcomes (1)
postoperative morbidity
Measured: 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Cook Biotech Incorporated
- Responsible party
- Sponsor
- Investigators
- Peter Christensen, M.D., Ph.d, Principal investigator, Department of Surgery P, Aarhus University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647569
- Sponsor's protocol ID
- VRAM M-20070240
- Acronym
- VRAM
- Status last verified
- Sep 2013
- First submitted
- 26 Mar 2008
- Last updated
- 9 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Collagen Mesh for Prevention of Ventral Hernia in Patients With Vertical Rectus Abdominis Musculocutaneus Flap for Advanced Pelvic Malignancy
- ClinicalTrials.gov ID
- NCT00647569
- Acronym / sponsor ID
- VRAM / VRAM M-20070240
- Conditions
- Incisional Hernia, Pelvic Cancer
- Keywords
- vertical rectus abdominis musculocutaneus flap, mesh repair, salvage surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Cook Biotech Incorporated
- Study start
- Apr 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 31 Mar 2008 (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.
The aim of the present project is to investigate whether use of biological mesh at the donor site of the rotation flap in closure of the abdominal wall reduce the frequency of incisional hernia formation compared to the usual abdominal wall closure after abdominal rotation flap operation in surgery for advanced pelvic cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Mesh repair, Procedure: Conventional facial closureNo previous major abdominal surgery |
| B | Experimental | Procedure: Mesh repair, Procedure: Conventional facial closurePrevious major abdominal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients operated with a vertical rectus abdominis musculocutaneus flap after abdominoperineal resection for advanced pelvic cancer.
Key exclusion criteria (6 listed)
- Pre or perioperative knowledge of disseminated malignancy
- Unable to follow the control program
- Known allergy to pig
- Compromised immune defense
- Artificial heart valve or recent (< 3 months) implanted foreign body
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 |
|---|---|---|
| Mesh repairAlso: Surgisis Gold Hernia repair graftA Surgisis Gold Hernia repair graft (Cook Biotech Incorporated, West Lafayette, IN, U.S.A) is placed at the donor site of the rectus abdominis muscles used for the rotation flap before the abdominal fascia is sutured with continuous running suture. | Procedure or surgery | A, B |
| Conventional facial closureThe abdominal facia is closed with with continuous running suture | Procedure or surgery | A, B |
Primary outcome
incisional hernia formation determined by CT scan 1 year postoperative
Time frame: 1 year postoperative
1 secondary outcome
postoperative morbidity
Time frame: 30 days postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
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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.
Peter Christensen, M.D., Ph.d principal investigator
Department of Surgery P, Aarhus University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mesh repair and Conventional facial closure in people with Incisional Hernia and Pelvic Cancer, run by University of Aarhus at 1 site in Denmark.
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 6 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: finished, as of the sponsor's last update on 9 Sep 2013. 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 Denmark. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
incisional hernia formation determined by CT scan 1 year postoperative (time frame: 1 year postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2013.