Short-term Outcome After Ventral Hernia Repair
October 3, 2019 updated by: Felix Harpain, Medical University of Vienna
Short-term Outcome After Ventral Hernia Repair Using Self-gripping Mesh in Subway Technique - a Retrospective Cohort Analysis
Hernia repair in sublay technique is widely accepted for ventral hernias, as it appears to be advantageous in terms of complication and recurrence rates.
Recently, self-gripping meshes are increasingly used for hernia repair with retromuscular mesh positioning.
However, real-life data on the safe use in that specific indication are still lacking.
Therefore, this study evaluated short-term postoperative outcome of self-gripping versus conventional non-self-gripping meshes in sublay hernia repair.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
244
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
A retrospective single-centre cohort study was performed for the time period of January 2011 to July 2018.
All patients, receiving a ventral hernia repair (including incisional, umbilical or epigastric hernias) in Rives-Stoppa retromuscular mesh placement technique (sublay), were included into the final analysis.
Description
Inclusion Criteria:
- ventral hernia repair in sublay technique
Exclusion Criteria:
- ventral hernia repair in other technique
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
self-gripping mesh
|
|
non-self-gripping mesh
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complication rate
Time Frame: 1 year
|
overall complication rate, seroma rate, SSI rate
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2011
Primary Completion (Actual)
July 1, 2018
Study Completion (Actual)
September 1, 2018
Study Registration Dates
First Submitted
October 2, 2019
First Submitted That Met QC Criteria
October 2, 2019
First Posted (Actual)
October 3, 2019
Study Record Updates
Last Update Posted (Actual)
October 7, 2019
Last Update Submitted That Met QC Criteria
October 3, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1258/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.