Incisional HerniaNCT01003067
Intraperitoneal Mesh-Implementation After Laparotomy
A study testing Mesh implementation in people with Incisional Hernia, run by Kantonsspital Liestal at 1 site in Switzerland.
Trial summary
Aim of the study is to evaluate the risk reduction of intraperitoneal mesh-implementation after laparotomy (Group 1) in a randomized control trial compared with patients with standard abdominal closure (Everett-suture). This is the primary endpoint. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Mesh implementation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2008to Jun 2020
- Phase
- Interventional
- 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
Who may be able to join
- Informed consent
- Median Laparotomy
Who cannot join
- Bowel perforation
- Pregnancy
- Palliative surgery
- Drug abuse
- Age under 18
- Mental disability
- Allergy to mesh components
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraperitoneal Mesh-Implementation After Laparotomy to Reduce Risk of Incisional Hernia: a Prospective Randomized Controlled Trial
Aim of the study is to evaluate the risk reduction of intraperitoneal mesh-implementation after laparotomy (Group 1) in a randomized control trial compared with patients with standard abdominal closure (Everett-suture). This is the primary endpoint. Second endpoints are the feasibility of mesh-implementation even after colorectal surgery, find risk factors for wound infection and incisional hernia.
- Conditions
- Incisional Hernia
- Being tested
- Mesh implementation
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesh implementationDevice
Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
| Study group | Role | What they receive |
|---|---|---|
| No Mesh | No intervention | Not described |
| Mesh Implementation | Experimental | Not described Receives: Device: Mesh implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Incisional Hernia At 2 Years Following Median Laparotomy
Primary endpoint was the incidence of incisional hernias at 2 years following midline laparotomy.
Measured: 2 years
Secondary outcomes (1)
Feasibility of Mesh-implementation Even After Colorectal Surgery, Find Risk Factors for Wound Infection and Incisional Hernia.
Secondary endpoints are the feasibility, the safety of the mesh stripe implantation including postoperative pain, and the incidence of incisional hernias at 5 years.
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startMar 2008
- Primary completionMay 2013
- Study completionJun 2020 (estimated)
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 (2)Papers the sponsor has linked to this study.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Liestal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph A. Maurer, MD, Kantonsspital Liestal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003067
- Sponsor's protocol ID
- 364/07
- Status last verified
- Aug 2019
- First submitted
- 27 Oct 2009
- Last updated
- 15 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Glauser PM, Brosi P, Speich B, Kaser SA, Heigl A, Rosenberg R, Maurer CA. Prophylactic Intraperitoneal Onlay Mesh Following Midline Laparotomy-Long-Term Results of a Randomized Controlled Trial. World J Surg. 2019 Jul;43(7):1669-1675. doi: 10.1007/s00268-019-04964-6.
PubMed 30824961Brosi P, Glauser PM, Speich B, Kaser SA, Maurer CA. Prophylactic Intraperitoneal Onlay Mesh Reinforcement Reduces the Risk of Incisional Hernia, Two-Year Results of a Randomized Clinical Trial. World J Surg. 2018 Jun;42(6):1687-1694. doi: 10.1007/s00268-017-4363-2.
PubMed 29159603
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraperitoneal Mesh-Implementation After Laparotomy to Reduce Risk of Incisional Hernia: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01003067
- Acronym / sponsor ID
- 364/07
- Conditions
- Incisional Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Kantonsspital LiestalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2020 (estimated)
- First posted
- 28 Oct 2009 (estimated)
- Results
- Posted 17 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the study is to evaluate the risk reduction of intraperitoneal mesh-implementation after laparotomy (Group 1) in a randomized control trial compared with patients with standard abdominal closure (Everett-suture). This is the primary endpoint. Second endpoints are the feasibility of mesh-implementation even after colorectal surgery, find risk factors for wound infection and incisional hernia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Mesh | No intervention | – |
| Mesh Implementation | Experimental | Device: Mesh implementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Informed consent
- Median Laparotomy
Key exclusion criteria (7 listed)
- Bowel perforation
- Pregnancy
- Palliative surgery
- Drug abuse
- Age under 18
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 implementationProphylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia. | Device | Mesh Implementation |
Primary outcome
Number of Participants With Incisional Hernia At 2 Years Following Median Laparotomy
Time frame: 2 years
Primary endpoint was the incidence of incisional hernias at 2 years following midline laparotomy.
1 secondary outcome
Feasibility of Mesh-implementation Even After Colorectal Surgery, Find Risk Factors for Wound Infection and Incisional Hernia.
Time frame: 5 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30824961Glauser PM, Brosi P, Speich B, Kaser SA, Heigl A, Rosenberg R, Maurer CA. Prophylactic Intraperitoneal Onlay Mesh Following Midline Laparotomy-Long-Term Results of a Randomized Controlled Trial. World J Surg. 2019 Jul;43(7):1669-1675. doi: 10.1007/s00268-019-04964-6.
- Derived from this study: PubMed 29159603Brosi P, Glauser PM, Speich B, Kaser SA, Maurer CA. Prophylactic Intraperitoneal Onlay Mesh Reinforcement Reduces the Risk of Incisional Hernia, Two-Year Results of a Randomized Clinical Trial. World J Surg. 2018 Jun;42(6):1687-1694. doi: 10.1007/s00268-017-4363-2.
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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?
A study testing Mesh implementation in people with Incisional Hernia, run by Kantonsspital Liestal at 1 site in Switzerland.
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 2 inclusion and 7 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 15 Aug 2019. 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 Switzerland. 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 17 Apr 2017). 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 Incisional Hernia At 2 Years Following Median Laparotomy (time frame: 2 years). 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 NCT01003067, which also lists 2 linked publications.
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 15 Aug 2019.