HerniaNCT04793009
Prophylactic Funnel Mesh to Prevent Parastomal Hernia in Permanent End Colostomy After Abdomino-perineal Resection
An observational study of Hernia and Colostomy Stoma, run by Walter Brunner.
Trial summary
This retrospective study asses if a prophylactic, funnel-shaped, intraperitoneal mesh prevents parastomal hernia in patients undergoing abdominoperineal rectum resection with permanent end colostomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Colostomy Stoma
- What is being tested?
- funnel-shaped, intraperitoneal mesh placement
- Type of treatment
- Medical device
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 28 Feb 2021
- 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 receiving elective abdominoperineal resection between January 2013 and December 2018 at the Cantonal Hospital of St. Gallen
Who may be able to join
- elecitve abdominoperineal resection
Who cannot join
- rejection of a retrospective data Analysis
- age under 18 years
- meshes other than the funnel-shaped mesh
About this study
Official title: Prophylactic Funnel Mesh to Prevent Parastomal Hernia in Permanent End Colostomy: A Retrospective Cohort Study
This retrospective study asses if a prophylactic, funnel-shaped, intraperitoneal mesh prevents parastomal hernia in patients undergoing abdominoperineal rectum resection with permanent end colostomy.
- Conditions
- Hernia, Colostomy Stoma
- Being tested
- funnel-shaped, intraperitoneal mesh placement
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
funnel-shaped, intraperitoneal mesh placementDevice
Implantation of a prophylactic, 3D funnel-shaped, intraperitoneal, non-absorbable and synthetic mesh (Dyna Mesh IPST 2x15x15 cm™ and 3x16x16 cm™, FEG Textiltechnik, Aachen, Germany,)
| Study group | Role | What they receive |
|---|---|---|
| mesh group | patients undergoing abdominoperineal resection with end colostomy and implantation of a prophylactic, funnel-shaped, intraperitoneal mesh Receives: Device: funnel-shaped, intraperitoneal mesh placement | |
| no-mesh group | patients undergoing abdominoperineal resection with end colostomy without implantation of a prophylactic, funnel-shaped, intraperitoneal mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of parastomal hernia
clinical or radiological diagnosed parastomal hernia
Measured: initial operation until an avarage of 3 years
Secondary outcomes (2)
Reoperations due to parastomal hernia
Reoperation due to problems caused by parastomal hernia
Measured: initial operation until an avarage of 3 years
Mesh-associated complications
any complications due to the mesh
Measured: initial operation until an avarage of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Jan 2013
- Primary completion31 Dec 2018
- Study completion28 Feb 2021
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Brunner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Walter Brunner, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793009
- Sponsor's protocol ID
- CHIR2021WB
- Other IDs
- 2021-00120
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Data will be made available to researchers whose proposed use of the data has been approved.
Publications
Ammann Y, Widmann B, Sparn M, Warschkow R, Weitzendorfer M, Brunner W. Prophylactic funnel mesh to prevent parastomal hernia in permanent end colostomy: A retrospective cohort study. Colorectal Dis. 2021 Oct;23(10):2627-2636. doi: 10.1111/codi.15817. Epub 2021 Sep 4.
PubMed 34265151
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Funnel Mesh to Prevent Parastomal Hernia in Permanent End Colostomy: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04793009
- Acronym / sponsor ID
- CHIR2021WB
- Conditions
- Hernia, Colostomy Stoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Walter BrunnerUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 11 Mar 2021 (actual)
- 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.
This retrospective study asses if a prophylactic, funnel-shaped, intraperitoneal mesh prevents parastomal hernia in patients undergoing abdominoperineal rectum resection with permanent end colostomy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mesh group | – | Device: funnel-shaped, intraperitoneal mesh placementpatients undergoing abdominoperineal resection with end colostomy and implantation of a prophylactic, funnel-shaped, intraperitoneal mesh |
| no-mesh group | – | –patients undergoing abdominoperineal resection with end colostomy without implantation of a prophylactic, funnel-shaped, intraperitoneal mesh |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving elective abdominoperineal resection between January 2013 and December 2018 at the Cantonal Hospital of St. Gallen
Key inclusion criteria (1 listed)
- elecitve abdominoperineal resection
Key exclusion criteria (3 listed)
- rejection of a retrospective data Analysis
- age under 18 years
- meshes other than the funnel-shaped 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 |
|---|---|---|
| funnel-shaped, intraperitoneal mesh placementImplantation of a prophylactic, 3D funnel-shaped, intraperitoneal, non-absorbable and synthetic mesh (Dyna Mesh IPST 2x15x15 cm™ and 3x16x16 cm™, FEG Textiltechnik, Aachen, Germany,) | Device | mesh group |
Primary outcome
Occurrence of parastomal hernia
Time frame: initial operation until an avarage of 3 years
clinical or radiological diagnosed parastomal hernia
2 secondary outcomes
Reoperations due to parastomal hernia
Time frame: initial operation until an avarage of 3 years
Mesh-associated complications
Time frame: initial operation until an avarage of 3 years
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 11 Mar 2021.
- Derived from this study: PubMed 34265151Ammann Y, Widmann B, Sparn M, Warschkow R, Weitzendorfer M, Brunner W. Prophylactic funnel mesh to prevent parastomal hernia in permanent end colostomy: A retrospective cohort study. Colorectal Dis. 2021 Oct;23(10):2627-2636. doi: 10.1111/codi.15817. Epub 2021 Sep 4.
- Individual participant dataSharing planned: Undecided. Data will be made available to researchers whose proposed use of the data has been approved.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia and Colostomy Stoma, run by Walter Brunner.
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 1 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 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Occurrence of parastomal hernia (time frame: initial operation until an avarage of 3 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 NCT04793009, 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 11 Mar 2021.