Hernia of Abdominal WallBASE cohortNCT02168231
Abdominal Wall Repair With Strattice in Germany: a Cohort Study
An observational study of Hernia of Abdominal Wall and Biologic Mesh, run by Erasmus Medical Center at 6 sites in Germany.
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 Mesh, Strattice
- What is being tested?
- Complex abdominal wall repair Strattice
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 6 sitesGermany
- Study dates
- 1 Feb 2017to 31 Dec 2018
- 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: Patients operated by members of the ROKI group (Arbeitsgruppe für Rekonstruktion komplexer Inzisionaler Hernien); i.e. a group of German hernia surgeons using Strattice for complex abdominal wall surgery. This group of surgeons is willing to share their patient cases with the investigators to achieve more knowledge on this delicate topic.
Who may be able to join
- Age of 18 years or older
- Signed informed consent
- Abdominal wall repair
- Strattice mesh implantation prior to inclusion in BASE cohort
Who cannot join
- Age under 18 years
- No signed informed consent
- Other operation than abdominal wall repair
- Other mesh than Strattice mesh
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Trauma Hospital Berlin
Berlin
Johann Wolfgang Goethe-University
Frankfurt am Main
Diakoniekrankenhaus Friederikenstiftung
Hanover
Agatharied Hospital
Hausham
Klinikum rechts der Isar, Technical University of Munich
München
St. Josefs-Hospital Wiesbaden
Wiesbaden
About this study
Official title: Abdominal Wall Repair With Strattice in Germany: a Cohort Study (BASE Cohort)
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 to investigate the short and long term effects of the Strattice biological mesh. The investigators will also inquire why a biologic mesh was used and what the direct and indirect costs were.
- Conditions
- Hernia of Abdominal Wall, Biologic Mesh, Strattice
- Being tested
- Complex abdominal wall repair Strattice
- Keywords
- Complex abdominal wall hernia, Biologic mesh, Strattice
- Medical subject headings
- Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex abdominal wall repair StratticeProcedure or surgery
Also called Strattice, Porcine accelular dermal matrix, Non-cross-linked biologic mesh
Not applicable (cross-sectional data from a cohort selected after initial complex abdominal wall surgery with Strattice)
| Study group | Role | What they receive |
|---|---|---|
| Complex abdominal wall repair Strattice | Complex abdominal wall repair Strattice Receives: Procedure: Complex abdominal wall repair Strattice |
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 performing physical examination.
Measured: At one year after initial operation
Postoperative complications
All postoperative complications and their treatment will be registered.
Measured: Postoperatively, until one year after initial operation
Survival
Any decease postoperatively
Measured: Postoperatively; until three years after initial operation
Secondary outcomes (7)
EHS incisional hernia classification
Classification according to Ventral Hernia Working Group classification (Breuing et al. Surgery 2010; 148(3): 544-58).
Measured: Perioperatively (noted just before or just after operation)
Mesh explantations
Strattice mesh explantation after operation
Measured: Postoperatively; until three years after initial operation
Additional "abdominal wall repair" operations
Additional "abdominal wall (hernia) repair" operations after initial implantation of Strattice
Measured: Postoperatively; until three years after initial operation
Indication of Strattice usage
Defined as preoperative conditions that influenced the decision (for instance: presence of stoma, fistulas, abscesses, etc.)
Measured: Perioperatively (noted just before or just after operation)
Quality of Life (questionnaire-based)
Measured with questionnaires (SF-36, EQ-5D-5L, BIQ)
Measured: Postoperatively; measured at one, two and three years after initial operation
Health economic analysis
Various cost-related parameters
Measured: Postoperatively; until one year after initial operation
Incisional hernia recurrence
This parameter will be assessed by taking a history of the patient, and performing physical examination.
Measured: At two and three 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 posted20 Jun 2014 (estimated)
- Study start1 Feb 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Unfallkrankenhaus Berlin, Johann Wolfgang Goethe University Hospital, Diakoniekrankenhaus Friederikenstift, Krankenhaus Agatharied Hausham, Technical University of Munich, St. Josefs-Hospital Wiesbaden GmbH
- Responsible party
- Principal investigator, Ruth Kaufmann, MD, Erasmus Medical Center
- Investigators
- Ruth Kaufmann, MD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168231
- Sponsor's protocol ID
- BASE cohort study
- Acronym
- BASE cohort
- Status last verified
- Aug 2018
- First submitted
- 12 Jun 2014
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kaufmann R, Isemer FE, Strey CW, Jeekel J, Lange JF, Woeste G. Non-cross-linked biological mesh in complex abdominal wall hernia: a cohort study. Langenbecks Arch Surg. 2020 May;405(3):345-352. doi: 10.1007/s00423-020-01881-4. Epub 2020 Apr 22.
PubMed 32323007
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Wall Repair With Strattice in Germany: a Cohort Study (BASE Cohort)
- ClinicalTrials.gov ID
- NCT02168231
- Acronym / sponsor ID
- BASE cohort / BASE cohort study
- Conditions
- Hernia of Abdominal Wall, Biologic Mesh, Strattice
- Keywords
- Complex abdominal wall hernia, Biologic mesh, Strattice
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Unfallkrankenhaus Berlin, Johann Wolfgang Goethe University Hospital, Diakoniekrankenhaus Friederikenstift, Krankenhaus Agatharied Hausham, Technical University of Munich, St. Josefs-Hospital Wiesbaden GmbH
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 20 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 to investigate the short and long term effects of the Strattice biological mesh. The investigators will also inquire why a biologic mesh was used and what the direct and indirect costs were.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Complex abdominal wall repair Strattice | – | Procedure: Complex abdominal wall repair StratticeComplex abdominal wall repair Strattice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated by members of the ROKI group (Arbeitsgruppe für Rekonstruktion komplexer Inzisionaler Hernien); i.e. a group of German hernia surgeons using Strattice for complex abdominal wall surgery. This group of surgeons is willing to share their patient cases with the investigators to achieve more knowledge on this delicate topic.
Key inclusion criteria (4 listed)
- Age of 18 years or older
- Signed informed consent
- Abdominal wall repair
- Strattice mesh implantation prior to inclusion in BASE cohort
Key exclusion criteria (4 listed)
- Age under 18 years
- No signed informed consent
- Other operation than abdominal wall repair
- Other mesh than Strattice mesh
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 |
|---|---|---|
| Complex abdominal wall repair StratticeAlso: Strattice, Porcine accelular dermal matrix, Non-cross-linked biologic meshNot applicable (cross-sectional data from a cohort selected after initial complex abdominal wall surgery with Strattice) | Procedure or surgery | Complex abdominal wall repair Strattice |
Primary outcome
Incisional hernia recurrence
Time frame: At one year after initial operation
This parameter will be assessed by taking a history of the patient, and performing physical examination.
Postoperative complications
Time frame: Postoperatively, until one year after initial operation
All postoperative complications and their treatment will be registered.
Survival
Time frame: Postoperatively; until three years after initial operation
Any decease postoperatively
7 secondary outcomes
EHS incisional hernia classification
Time frame: Perioperatively (noted just before or just after operation)
Mesh explantations
Time frame: Postoperatively; until three years after initial operation
Additional "abdominal wall repair" operations
Time frame: Postoperatively; until three years after initial operation
Indication of Strattice usage
Time frame: Perioperatively (noted just before or just after operation)
Quality of Life (questionnaire-based)
Time frame: Postoperatively; measured at one, two and three years after initial operation
Health economic analysis
Time frame: Postoperatively; until one year after initial operation
Incisional hernia recurrence
Time frame: At two and three years after initial operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Derived from this study: PubMed 32323007Kaufmann R, Isemer FE, Strey CW, Jeekel J, Lange JF, Woeste G. Non-cross-linked biological mesh in complex abdominal wall hernia: a cohort study. Langenbecks Arch Surg. 2020 May;405(3):345-352. doi: 10.1007/s00423-020-01881-4. Epub 2020 Apr 22.
- 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 principal investigator
Erasmus Medical Center
6 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 Mesh, run by Erasmus Medical Center at 6 sites in Germany.
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 4 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 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. 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?
Incisional hernia recurrence (time frame: At one year after initial operation). The study lists 3 primary outcomes in all. 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 NCT02168231, 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 Aug 2018.