- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03935490
The Transrectus Sheath Pre-peritoneal (TREPP) Technique for Strangulated Inguinal Hernia: a Case-series
March 25, 2020 updated by: Thomas Zwols, University Medical Center Groningen
n the Sint Jansdal Hospital in Harderwijk, the Netherlands, the TREPP technique is the standard operating procedure for patients with inguinal hernia.
Starting from 2006, this procedure has also been used on patients that presented with an acute strangulated inguinal hernia in the emergency department, instead of the more common Lichtenstein technique.
The goal of this retrospective case series is to assess the feasibility of the TREPP technique in case of an acute strangulated inguinal hernia.
Patient records from 2006 until 2016 will be used to search for patients treated for acute inguinal hernia in that period.
After applying the in- and exclusion criteria, patients who are eligible for inclusion will be contacted by telephone.
They will be asked if they are willing to visit the surgical outpatient department once and fill out two questionnaires.
The data of these questionnaires will be analyzed and published.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
45
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gelderland
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Harderwijk, Gelderland, Netherlands, 3844 DG
- St Jansdal Hospital
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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
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
From all acute inguinal hernia repairs patient records will searched for e-TREPP procedures.
All patients will be asked to visit the outpatient department.
Description
Inclusion Criteria:
- Emergency surgery for suspected strangulated inguinal hernia (within 6 hours after admission)
- e-TREPP performed
Exclusion Criteria:
- No emergency surgery (for instance, surgery day after admission or later).
- No e-TREPP performed
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
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
e-TREPP
Patients with strangulated inguinal hernia treated with e-TREPP
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The Trans REctussheath PrePeritoneal mesh repair (TREPP) was developed in 2006 as an open preperitoneal technique to reduce CPIP.
In short: a 4-5 centimeters (cm) transverse incision is made about 1 cm above the localization of the deep inguinal ring.
The anterior rectus sheath is opened.
After retracting the rectus muscle medially, the preperitoneal space (PPS) is bluntly dissected and a complete overview can be achieved.
All possible hernia orifices can be visualized such as: a direct, indirect, pantaloon, and/or femoral hernia.
A self-expandable mesh is then positioned in the PPS.
Due to the "upstream principle" no mesh fixation is necessary.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chronic postoperative inguinal pain according to Visual Analog Scale
Time Frame: From surgery date up to 12 years postoperatively
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Patients will be asked to fill out the VAS on a horizontal line of 10 millimeters long.
Patients will be asked to mark the point that indicated the amount of pain they experience.
The distance from the left marker will be measured, with increasing distance at greater pain intensity.
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From surgery date up to 12 years postoperatively
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Recurrence rate
Time Frame: From surgery date up to 12 years postoperatively
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Patient electronic records will be searched for re-operations for recurrent inguinal hernia.
Also, patients will be asked in the outpatient department if they received recurrence surgery or suffer new complaints.
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From surgery date up to 12 years postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short-term complications
Time Frame: Complications occuring from the start of the operation up to 30 days postoperative
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Short term complications included: hematoma, wound infection, re-admission rate, medical complications and death.
These complications will be retrospectively analyzed via the electronic patient files.
They will be verified at the outpatient department.
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Complications occuring from the start of the operation up to 30 days postoperative
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Sexual complaints related to e-TREPP
Time Frame: Between >30 days postoperatively and through study completion, average 6 years
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All patients will be asked if they experienced any sexual problems related to the e-TREPP surgery.
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Between >30 days postoperatively and through study completion, average 6 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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)
May 1, 2019
Primary Completion (Actual)
July 1, 2019
Study Completion (Actual)
July 12, 2019
Study Registration Dates
First Submitted
April 29, 2019
First Submitted That Met QC Criteria
May 1, 2019
First Posted (Actual)
May 2, 2019
Study Record Updates
Last Update Posted (Actual)
March 26, 2020
Last Update Submitted That Met QC Criteria
March 25, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201900143
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.
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