Hernia, AbdominalENHANCENCT01268514
ENHANCE: A Prospective EvaluatioN of Permacol™ in tHe Repair of Complex AbdomiNal Wall CasEs
An observational study of Hernia, Abdominal and Abdominal Injuries, run by Medtronic - MITG at 12 sites in 5 countries.
Trial summary
The objective of this prospective study is to evaluate short-term, mid-term, and long-term clinical outcomes associated with the use of Permacol™ Biological Implant in the treatment of complex abdominal wall defects Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Abdominal, Abdominal Injuries
- How many people
- 115 participants
- Where
- 12 sitesin 5 countries
- Study dates
- Feb 2011to Nov 2016
- 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: All subjects who will undergo planned surgical treatment for complex abdominal wall repair with Permacol™ implantation and agree to 36 months of follow-up.
Who may be able to join
- Subjects who meet all of the following criteria will be eligible for study enrollment:
- Subjects who are 18 years of age and older
- Subjects of either sex
- Subjects who require complex abdominal repair using Permacol™ Biological Implant.
- Subjects who are willing and able to adhere to protocol requirements and provide written informed consent
Who cannot join
- All subjects who meet any of the following criteria should not be enrolled into the study:
- Subjects who are pregnant
- Subjects with a medical condition that in the opinion of the investigator may preclude participation (e.g. Ehlers Danlos Syndrome) or interfere with completion of study follow-up
- Subjects may not participate in any other clinical study that clinically interferes with this study while enrolled
- Concomitant use of a synthetic or another biologic mesh
- Subjects who require use of Permacol™ as only temporary closure with planned reoperation, or Permacol™ used as a temporary dressing in an open abdomen
Show all 11Show fewer
- Subject who has systemic sepsis at the time of Permacol™ implantation
- Subject with ongoing necrotizing pancreatitis
- Subject who requires use of Permacol™ in parastomal hernia repair alone, where there is no other anterior wall repair
- Subject who requires prophylactic use of Permacol™ in the formation of stoma with anterior wall repair
- Permacol™ used in pelvic floor reconstruction
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
United Kingdom4 sites
Royal Devon and Exeter Hospital
Exeter, Wonford, EX2 5DW
Whipps Cross University Hospital
Leytonstone, London, E11 1NR
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
Torbay Hospital
Torquay, TQ2 7AA
Belgium3 sites
AZ St Lucas
Ghent
CHU Ambroise Pare
Mons, 7000
CHU Ambroise Paré
Mons
Italy3 sites
RCCS Istituto Clinico Humanitas di Milano
Milan
Istituto Nazionale Tumori
Naples
University Hospital (C/O Istituto Clinica Chirugica II)
Rome
About this study
Official title: ENHANCE: A Prospective Long-term EvaluatioN of the Use of Permacol™ Biological Implant in tHe Repair of Complex AbdomiNal Wall CasEs
The objective of this prospective study is to evaluate short-term, mid-term, and long-term clinical outcomes associated with the use of Permacol™ Biological Implant in the treatment of complex abdominal wall defects
Read the detailed description
This will be a prospective, multi-centre, non-randomized study to collect post-market clinical data on Permacol™ Biological Implant following complex abdominal wall repair (including abdominal wall defects and fascial dehiscence). The subjects will have baseline and day of surgery visits performed, and then subjects will return to the investigator for evaluation of defect and safety related morbidities at follow up visits scheduled at 1 month, 6 months, 12 months, 24 months, and 36 months post-surgery.
The study will enroll up to 200 subjects at up to 20 sites. Enrollment is anticipated to take between 18 and 24 months.
- Conditions
- Hernia, Abdominal, Abdominal Injuries
- Keywords
- Complex, Abdominal Wall Reconstruction, AWR, Hernia
- Medical subject headings
- Hernia, Abdominal, Abdominal Injuries, Hernia
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery
Characterize longitudinal outcomes at 36 months post-surgery of the proportion of subjects who undergo reoperation for hernia or hernia recurrence.
Measured: 36 months post-surgery
Secondary outcomes (5)
Number of Participants With Short-term and Mid-term Outcomes Who Underwent Hernia Reoperation or Hernia Recurrence
Characterize short-term and mid-term outcomes within 24 months post-surgery of the proportion of subjects who undergo reoperation for hernia or hernia recurrence.
Measured: 24 months post-surgery
QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months.
Quality of Life by Carolina's Comfort Scale at 6 months, 12 months, 24 months, and 36 months. The areas of assessment were: Sensation of Mesh, Pain, and Movement Limitations at each of the follow-up time points. Unscheduled surgery is any surgery that is performed outside of the primary study procedure.
The scale measurements: 0 = no symptoms; 1 = mild but not bothersome symptoms; 2 = mild and bothersome symptoms; 3 = moderate and/or daily symptoms,;4 = severe symptoms; 5 = disabling symptoms
Measured: 6, 12, 24 and 36 months post-surgery. We excluded patients who were not included in this assessment at the various time-points.
Patient Satisfaction Questionnaire - Right Choice to Have Surgery
Patient Satisfaction Questionnaire at 6 months, 12 months, 24 months, and 36 months.
Question: Was it the right choice to have the surgery?
Measured: 6, 12, 24 and 36 months post-surgery
Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome
Patient Satisfaction Questionnaire at 6 months, 12 months, 24 months, and 36 months.
Question: How satisfied are you with the outcome of the operation?
Measured: 6, 12, 24 and 36 months post-surgery
Number of Participants With Post-op Complications
Subject incidence of post-operative complications, specifically: wound infection, seroma, hematoma, wound dehiscence, and fistula. Unscheduled surgery is any surgery that is performed outside of the primary study procedure.
Measured: 6, 12, 24 and 36 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2010 (estimated)
- Study startFeb 2011
- Primary completionNov 2016
- Study completionNov 2016
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.
- Other trials for Hernia, AbdominalStudies 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
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pasquale Giordano, MD, Principal investigator, Whipps Cross University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268514
- Sponsor's protocol ID
- COVPERH0108
- Acronym
- ENHANCE
- Status last verified
- May 2024
- First submitted
- 29 Dec 2010
- Last updated
- 10 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENHANCE: A Prospective Long-term EvaluatioN of the Use of Permacol™ Biological Implant in tHe Repair of Complex AbdomiNal Wall CasEs
- ClinicalTrials.gov ID
- NCT01268514
- Acronym / sponsor ID
- ENHANCE / COVPERH0108
- Conditions
- Hernia, Abdominal, Abdominal Injuries
- Keywords
- Complex, Abdominal Wall Reconstruction, AWR, Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Feb 2011 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 31 Dec 2010 (estimated)
- Results
- Posted 8 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this prospective study is to evaluate short-term, mid-term, and long-term clinical outcomes associated with the use of Permacol™ Biological Implant in the treatment of complex abdominal wall defects
Detailed description
This will be a prospective, multi-centre, non-randomized study to collect post-market clinical data on Permacol™ Biological Implant following complex abdominal wall repair (including abdominal wall defects and fascial dehiscence). The subjects will have baseline and day of surgery visits performed, and then subjects will return to the investigator for evaluation of defect and safety related morbidities at follow up visits scheduled at 1 month, 6 months, 12 months, 24 months, and 36 months post-surgery.
The study will enroll up to 200 subjects at up to 20 sites. Enrollment is anticipated to take between 18 and 24 months.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects who will undergo planned surgical treatment for complex abdominal wall repair with Permacol™ implantation and agree to 36 months of follow-up.
Key inclusion criteria (5 listed)
- Subjects who are 18 years of age and older
- Subjects of either sex
- Subjects who require complex abdominal repair using Permacol™ Biological Implant.
- Subjects who are willing and able to adhere to protocol requirements and provide written informed consent
Key exclusion criteria (11 listed)
- All subjects who meet any of the following criteria should not be enrolled into the study:
- Subjects who are pregnant
- Subjects with a medical condition that in the opinion of the investigator may preclude participation (e.g. Ehlers Danlos Syndrome) or interfere with completion of study follow-up
- Subjects may not participate in any other clinical study that clinically interferes with this study while enrolled
- Concomitant use of a synthetic or another biologic mesh
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery
Time frame: 36 months post-surgery
Characterize longitudinal outcomes at 36 months post-surgery of the proportion of subjects who undergo reoperation for hernia or hernia recurrence.
5 secondary outcomes
Number of Participants With Short-term and Mid-term Outcomes Who Underwent Hernia Reoperation or Hernia Recurrence
Time frame: 24 months post-surgery
QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months.
Time frame: 6, 12, 24 and 36 months post-surgery. We excluded patients who were not included in this assessment at the various time-points.
Patient Satisfaction Questionnaire - Right Choice to Have Surgery
Time frame: 6, 12, 24 and 36 months post-surgery
Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome
Time frame: 6, 12, 24 and 36 months post-surgery
Number of Participants With Post-op Complications
Time frame: 6, 12, 24 and 36 months post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Pasquale Giordano, MD principal investigator
Whipps Cross University Hospital
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, Abdominal and Abdominal Injuries, run by Medtronic - MITG at 12 sites in 5 countries.
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 5 inclusion and 11 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 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom, Belgium, Italy, Germany, Luxembourg. 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 8 Feb 2019). 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?
Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery (time frame: 36 months post-surgery). 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 10 May 2024.