Hernia of Abdominal WallNCT02166112
The Permacol Dutch Cohort Study
An observational study of Hernia of Abdominal Wall and Biologic Implant, run by Erasmus Medical Center at 24 sites in Netherlands.
Trial summary
Incisional hernia is the most frequently seen long term complication in surgery causing much morbidity and even mortality in patients. Despite studies on the optimal closing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia of Abdominal Wall, Biologic Implant, Infected Hernioplasty Mesh
- What is being tested?
- Permacol mesh placement
- Type of treatment
- Surgery or procedure
- How many people
- 77 participants
- Where
- 24 sitesNetherlands
- Study dates
- Apr 2013to May 2014
- Phase
- Observational
- 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
Study population: The design of the trial will be a cross sectional cohort study. We will be gathering information from all the centers in the Netherlands who have used the Permacol© mesh in the past to treat complicated abdominal wall defects. Patients will be asked to return to the hospitals outpatient clinic. A total of around 70 patients will be included into the study.
Who may be able to join
- Signed informed consent
- Complicated abdominal wall hernia repair
- Permacol© mesh implantation
Who cannot join
- No signed informed consent
- Operation other than Complicated abdominal wall hernia repair
- Implant other than Permacol© mesh implantation
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Netherlands24 sites
Meander MC
Amersfoort
Onze Lieve Vrouwe Gasthuis
Amsterdam
Rijnstate
Arnhem
Lievensberg
Bergen op Zoom
Amphia
Breda
Reinier de Graaf Gasthuis
Delft
Nij Smellinghe
Drachten
Catharina
Eindhoven
Groene Hart
Gouda
UMC Groningen
Groningen
Atrium MC
Heerlen
Tergooi ziekenhuizen
Hilversum
Spaarne ziekenhuis
Hoofddorp
MC Leeuwarden
Leeuwarden
MUMC+
Maastricht
Waterland
Purmerend
Franciscus
Roosendaal
Erasmus University Medical Center
Rotterdam
Havenziekenhuis
Rotterdam
Orbis MC
Sittard
MC Haaglanden
The Hague
TweeSteden
Tilburg
UMC Utrecht
Utrecht
VieCuri
Venlo
About this study
Incisional hernia is the most frequently seen long term complication in surgery causing much morbidity and even mortality in patients. Despite studies on the optimal closing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %. It has been established that implementing a mesh reduces recurrence of the incisional hernia but still the results of repair are often disappointing. Incisional hernias can become increasingly complex due to complicated abdominal wall defects caused by a disturbed anatomy, fistulas, burst abdomen, wound and mesh infections. In these cases it is not save to repair the incisional hernia by means of a synthetic mesh and other augmentation tools need to be implemented.
In the recent years the use of biological meshes has been gaining popularity. Recent reports of the use of collagen-based prosthesis have suggested that they support new vessel growth, do not excite a significant foreign body reaction, form fewer adhesions, are well incorporated into host tissues with minimal wound contraction, and can be used in grossly contaminated wounds with fewer infective complications. Biologic meshes are harvested from a source tissue and processed for medical use but they vary widely in their processing methods. They include tissues of human or animal origins, both chemically cross-linked and non cross-linked processes, and submucosal, pericardial, or dermal tissue sources. Current studies investigating the effectiveness of these meshes are small and have short periods of follow-up. These shortcomings can be explained to high cost of the meshes and unclear indication when to use a biological mesh.
The aim of this study is investigate the short and long term effects of the Permacol© biological mesh. Also the investigators will be inquiring why a biologic mesh was used, what is the true indication to use a biological mesh.
- Being tested
- Permacol mesh placement
- Keywords
- Hernia of Abdominal Wall, Biologic implant, Infected Hernioplasty Mesh
- Medical subject headings
- Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permacol mesh placementProcedure or surgery
All patients were treated for a complex abdominal wall hernia by implantation of Permacol mesh. This intervention took place before patients were included in the cohort.
| Study group | Role | What they receive |
|---|---|---|
| Permacol mesh placement | No intervention performed Receives: Procedure: Permacol mesh placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional Hernia recurrence
This parameter will be assessed by taking a history of the patient and assessing operation room reports.
Measured: One and two year after initial operation
Secondary outcomes (5)
Mesh explantations
This parameter will be assessed by taking a history of the patient and assessing operation room reports.
Measured: Anytime after abdominal wall reconstruction with Permacol until two years after operation
Postoperative complications
This parameter will be assessed by taking a history of the patient and assessing patient reports and operation room reports.
Measured: All postoperative complications are assessed until two years after initial operation
Additional "abdominal wall repair" operations
This parameter will be assessed by taking a history of the patient and assessing patient reports and operation room reports.
Measured: After initial abdominal wall reconstruction with Permacol until two years after initial operation
Indication of Permacol usage
The indication for usage of Permacol was noted just before or just after operation.
Measured: Perioperatively
Quality of Life
This parameter will be assessed various questionnaires (ShortForm-36, EuroQOL (EQ-5D-5L), and Body Image Questionnaire).
Measured: A year or longer after initial abdominal wall reconstruction until two years after initial operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startApr 2013
- Primary completionNov 2013
- Study completionMay 2014
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 Hernia of Abdominal WallStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amphia, Breda, the Netherlands, Catharina Ziekenhuis Eindhoven, Franciscus, Roosendaal, the Netherlands, Groene Hart, Gouda, the Netherlands, Havenziekenhuis, Lievensberg, Bergen op Zoom, the Netherlands, Medical Center Haaglanden, MC Leeuwarden, Leeuwarden, the Netherlands, Meander MC, Amersfoort, the Netherlands, Maastricht University Medical Center, Nij Smellinghe, Drachten, the Netherlands, OLVG, Amsterdam, the Netherlands, Orbis MC, Sittard, the Netherlands, Reinier de Graaf Groep, Rijnstate, Arnhem, the Netherlands, Spaarne ziekenhuis, Hoofddorp, the Netherlands, Tergooi ziekenhuizen, Hilversum, the Netherlands, The Elisabeth-TweeSteden Hospital, UMC Groningen, Groningen, the Netherlands, UMC Utrecht, Utrecht, the Netherlands, VieCuri, Venlo, the Netherlands, Waterland, Purmerend, the Netherlands, Zuyderland Medisch Centrum, Sittard-Geleen, the Netherlands
- Responsible party
- Principal investigator, Ruth Kaufmann, MD, Erasmus Medical Center
- Investigators
- Ruth Kaufmann, MD, Study chair, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166112
- Sponsor's protocol ID
- Permacol Dutch Cohort Study
- Status last verified
- Apr 2017
- First submitted
- 10 Jun 2014
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kaufmann R, Timmermans L, van Loon YT, Vroemen JPAM, Jeekel J, Lange JF. Repair of complex abdominal wall hernias with a cross-linked porcine acellular matrix: cross-sectional results of a Dutch cohort study. Int J Surg. 2019 May;65:120-127. doi: 10.1016/j.ijsu.2019.03.023. Epub 2019 Apr 1.
PubMed 30946996
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Permacol Dutch Cohort Study
- ClinicalTrials.gov ID
- NCT02166112
- Acronym / sponsor ID
- Permacol Dutch Cohort Study
- Keywords
- Hernia of Abdominal Wall, Biologic implant, Infected Hernioplasty Mesh
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Amphia, Breda, the Netherlands, Catharina Ziekenhuis Eindhoven, Franciscus, Roosendaal, the Netherlands, Groene Hart, Gouda, the Netherlands, Havenziekenhuis, Lievensberg, Bergen op Zoom, the Netherlands, Medical Center Haaglanden, MC Leeuwarden, Leeuwarden, the Netherlands, Meander MC, Amersfoort, the Netherlands, Maastricht University Medical Center, Nij Smellinghe, Drachten, the Netherlands, OLVG, Amsterdam, the Netherlands, Orbis MC, Sittard, the Netherlands, Reinier de Graaf Groep, Rijnstate, Arnhem, the Netherlands, Spaarne ziekenhuis, Hoofddorp, the Netherlands, Tergooi ziekenhuizen, Hilversum, the Netherlands, The Elisabeth-TweeSteden Hospital, UMC Groningen, Groningen, the Netherlands, UMC Utrecht, Utrecht, the Netherlands, VieCuri, Venlo, the Netherlands, Waterland, Purmerend, the Netherlands, Zuyderland Medisch Centrum, Sittard-Geleen, the Netherlands
- Study start
- Apr 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 18 Jun 2014 (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.
Incisional hernia is the most frequently seen long term complication in surgery causing much morbidity and even mortality in patients. Despite studies on the optimal closing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %. It has been established that implementing a mesh reduces recurrence of the incisional hernia but still the results of repair are often disappointing. Incisional hernias can become increasingly complex due to complicated abdominal wall defects caused by a disturbed anatomy, fistulas, burst abdomen, wound and mesh infections. In these cases it is not save to repair the incisional hernia by means of a synthetic mesh and other augmentation tools need to be implemented.
In the recent years the use of biological meshes has been gaining popularity. Recent reports of the use of collagen-based prosthesis have suggested that they support new vessel growth, do not excite a significant foreign body reaction, form fewer adhesions, are well incorporated into host tissues with minimal wound contraction, and can be used in grossly contaminated wounds with fewer infective complications. Biologic meshes are harvested from a source tissue and processed for medical use but they vary widely in their processing methods. They include tissues of human or animal origins, both chemically cross-linked and non cross-linked processes, and submucosal, pericardial, or dermal tissue sources. Current studies investigating the effectiveness of these meshes are small and have short periods of follow-up. These shortcomings can be explained to high cost of the meshes and unclear indication when to use a biological mesh.
The aim of this study is investigate the short and long term effects of the Permacol© biological mesh. Also the investigators will be inquiring why a biologic mesh was used, what is the true indication to use a biological mesh.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Permacol mesh placement | – | Procedure: Permacol mesh placementNo intervention performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The design of the trial will be a cross sectional cohort study. We will be gathering information from all the centers in the Netherlands who have used the Permacol© mesh in the past to treat complicated abdominal wall defects. Patients will be asked to return to the hospitals outpatient clinic. A total of around 70 patients will be included into the study.
Key inclusion criteria (3 listed)
- Signed informed consent
- Complicated abdominal wall hernia repair
- Permacol© mesh implantation
Key exclusion criteria (3 listed)
- No signed informed consent
- Operation other than Complicated abdominal wall hernia repair
- Implant other than Permacol© mesh implantation
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 mesh placementAll patients were treated for a complex abdominal wall hernia by implantation of Permacol mesh. This intervention took place before patients were included in the cohort. | Procedure or surgery | Permacol mesh placement |
Primary outcome
Incisional Hernia recurrence
Time frame: One and two year after initial operation
This parameter will be assessed by taking a history of the patient and assessing operation room reports.
5 secondary outcomes
Mesh explantations
Time frame: Anytime after abdominal wall reconstruction with Permacol until two years after operation
Postoperative complications
Time frame: All postoperative complications are assessed until two years after initial operation
Additional "abdominal wall repair" operations
Time frame: After initial abdominal wall reconstruction with Permacol until two years after initial operation
Indication of Permacol usage
Time frame: Perioperatively
Quality of Life
Time frame: A year or longer after initial abdominal wall reconstruction until two years after initial operation
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 7 Apr 2017.
- Derived from this study: PubMed 30946996Kaufmann R, Timmermans L, van Loon YT, Vroemen JPAM, Jeekel J, Lange JF. Repair of complex abdominal wall hernias with a cross-linked porcine acellular matrix: cross-sectional results of a Dutch cohort study. Int J Surg. 2019 May;65:120-127. doi: 10.1016/j.ijsu.2019.03.023. Epub 2019 Apr 1.
- Individual participant dataSharing planned: No
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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.
Ruth Kaufmann, MD study chair
Erasmus Medical Center
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia of Abdominal Wall and Biologic Implant, run by Erasmus Medical Center at 24 sites in Netherlands.
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 3 inclusion and 3 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 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Netherlands. 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?
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 recurrence (time frame: One and two year after initial operation). 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 NCT02166112, 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 7 Apr 2017.