Abdominal Wall DefectsNCT01214252
A Retrospective Study Evaluating the Use of Permacol Surgical Implant in the Repair of Abdominal Wall Defects
An observational study of Abdominal Wall Defects, run by Medtronic - MITG at 1 site in United States.
Trial summary
To evaluate short, mid and long term clinical outcomes associated with the use of Permacol in the treatment of abdominal wall defects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Wall Defects
- What is being tested?
- Permacol Surgical Implant
- Type of treatment
- Medical device
- How many people
- 343 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jan 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Patients who have undergone surgical repair of their abdominal wall defects with Permacol Surgical Implants with at least 12 months(-30days)follow-up
Who may be able to join
- Equal or over 18 years of age
- Had undergone surgical repair or reconstruction of abdominal wall defects, ventral hernias or incisional hernias using Permacol Surgical Implant.
- At least 12 months of follow-up post date of surgery (-30 days)
- Undergone open or laparoscopic repairs
Who cannot join
- Had undergone inguinal, parastomal, diaphragmatic or paraesophageal/hiatal hernia repair
- Any prior use of Permacol in abdominal wall repair
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate short, mid and long term clinical outcomes associated with the use of Permacol in the treatment of abdominal wall defects.
- Conditions
- Abdominal Wall Defects
- Being tested
- Permacol Surgical Implant
- Keywords
- Repair of patients' abdominal wall defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permacol Surgical ImplantDevice
Permacol Surgical Implant
| Study group | Role | What they receive |
|---|---|---|
| Permacol Patients | Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up. Receives: Device: Permacol Surgical Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed Hernia Recurrence
Confirmed hernia or hernia recurrence: Proportion of patients treated with Permacol Surgical Implant who experienced hernia or hernia recurrence at the repair site. Hernia or recurrence is defined by hernia diagnosis during clinical assessment by surgeon or medical chart review
Measured: 12 months
Secondary outcomes (2)
Total Unconfirmed Hernia or Hernia Recurrence
Total unconfirmed hernia or hernia recurrence at the repair site by year (Number and percentage)
Unconfirmed hernia or recurrence reported by the subject is defined by confirmation of hernia symptoms based on results of the Symptoms Questionniare but not confirmed by clinical assessment by a surgeon or medical chart review
Measured: 12 Months
Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed
Confirmed and Unconfirmed hernia or hernia recurrence by year from Year 2 to last year observed
Measured: Year 2 to Year 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Wall DefectsStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214252
- Sponsor's protocol ID
- COVPERH0046
- Status last verified
- Apr 2014
- First submitted
- 30 Sep 2010
- Last updated
- 9 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Chand B, Indeck M, Needleman B, Finnegan M, Van Sickle KR, Ystgaard B, Gossetti F, Pullan RD, Giordano P, McKinley A. A retrospective study evaluating the use of Permacol surgical implant in incisional and ventral hernia repair. Int J Surg. 2014;12(4):296-303. doi: 10.1016/j.ijsu.2014.01.025. Epub 2014 Feb 5.
PubMed 24508570
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study Evaluating the Use of Permacol Surgical Implant in the Repair of Abdominal Wall Defects
- ClinicalTrials.gov ID
- NCT01214252
- Acronym / sponsor ID
- COVPERH0046
- Conditions
- Abdominal Wall Defects
- Keywords
- Repair of patients' abdominal wall defects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 5 Oct 2010 (estimated)
- Results
- Posted 20 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate short, mid and long term clinical outcomes associated with the use of Permacol in the treatment of abdominal wall defects.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Permacol Patients | – | Device: Permacol Surgical ImplantPatients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone surgical repair of their abdominal wall defects with Permacol Surgical Implants with at least 12 months(-30days)follow-up
Key inclusion criteria (4 listed)
- Equal or over 18 years of age
- Had undergone surgical repair or reconstruction of abdominal wall defects, ventral hernias or incisional hernias using Permacol Surgical Implant.
- At least 12 months of follow-up post date of surgery (-30 days)
- Undergone open or laparoscopic repairs
Key exclusion criteria (2 listed)
- Had undergone inguinal, parastomal, diaphragmatic or paraesophageal/hiatal hernia repair
- Any prior use of Permacol in abdominal wall repair
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 |
|---|---|---|
| Permacol Surgical ImplantPermacol Surgical Implant | Device | Permacol Patients |
Primary outcome
Confirmed Hernia Recurrence
Time frame: 12 months
Confirmed hernia or hernia recurrence: Proportion of patients treated with Permacol Surgical Implant who experienced hernia or hernia recurrence at the repair site. Hernia or recurrence is defined by hernia diagnosis during clinical assessment by surgeon or medical chart review
2 secondary outcomes
Total Unconfirmed Hernia or Hernia Recurrence
Time frame: 12 Months
Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed
Time frame: Year 2 to Year 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24508570Chand B, Indeck M, Needleman B, Finnegan M, Van Sickle KR, Ystgaard B, Gossetti F, Pullan RD, Giordano P, McKinley A. A retrospective study evaluating the use of Permacol surgical implant in incisional and ventral hernia repair. Int J Surg. 2014;12(4):296-303. doi: 10.1016/j.ijsu.2014.01.025. Epub 2014 Feb 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Wall Defects, run by Medtronic - MITG at 1 site in United States.
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 4 inclusion and 2 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 May 2014. 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 United States. 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?
Yes. Results are posted in the registry (first posted 20 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Confirmed Hernia Recurrence (time frame: 12 months). 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 NCT01214252, 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 9 May 2014.