- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06417359
Comparison of Mesh Fixation and Non-Fixation in eTEP
Comparison of Mesh Fixation and Non-Fixation in Laparoscopic eTEP Inguinal Hernia Repair
Inguinal hernia surgery is one of the most frequently performed procedures among general surgery cases. As with many open surgical methods, this repair is also performed laparoscopically. Among these closed methods, the one method is laparoscopic extended total extraperitoneal repair (eTEP). The benefits of laparoscope include less postoperative pain and complications, faster recovery, reduced chronic pain, and recurrence rate.
One of the recent debates regarding the laparoscopic technique is mesh fixation. Fixation of the mesh to the cooper ligament can prevent mesh migration and consequently reduce the recurrence rate. However, it has been reported that this fixation may increase postoperative pain. Several studies have reported that recurrence may be due to inadequate mesh fixation technique. In contrast, other prospective randomized studies have found relapse unrelated to mesh fixation.
In the eTEP technique, dissection is performed in a larger area than in TEP. For this reason, it can be thought that the possibility of mesh displacement is higher in the eTEP procedure. The purpose of this study is to confirm this idea with a prospective study. There are studies in the literature on mesh fixation related to the total extraperitoneal repair (TEP) technique. However, there is no study on mesh detection in the eTEP technique. The aim of the study is to compare patients who underwent withmesh fixation and without mesh fixation laparoscopic eTEP repair in terms of clinical data such as mesh displacement and hernia recurrence, chronic pain, length of hospital stay, and postoperative complications.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Abdullah Hilmi Yılmaz, MD
- Phone Number: 0432 222 00 10
- Email: drabdullahhilmi@gmail.com
Study Locations
-
-
-
Van, Turkey
- Recruiting
- University of Health Science Van Training and Research Hospital
-
Contact:
- Abdullah Hilmi Yılmaz, MD
- Phone Number: 0432 222 00 10
- Email: drabdullahhilmi@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with unilateral inguinal hernias,
- Patients aged 18-65.
Exclusion Criteria:
- Younger than 18 years, and older than 65 years,
- Incarcerated or strangulated inguinal hernias,
- Patients with bilateral inguinal hernias,
- Patients who are contraindicated to receive general anesthesia,
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: eTEP No Mesh Fixation Group
In 30 patients; Inguinal hernia surgery will be performed with the eTEP method and the 15x12x10 cm polyprolene patch used in this surgery will be marked with small metallic clips from the lateral, superomedial and inferomedial sides.
During the surgery, the mesh will not be fixed to the Cooper ligament.
Patients whose pain scores (VAS score) are measured on the first postoperative day and who are suitable for discharge will be discharged after a pelvis x-ray is taken.
One month after the surgery and 6 months later, patients will be called to the outpatient clinic and examined, their pain scores will be measured (VAS score) and pelvic radiographs will be taken.
The movement of the clips marked on the patch will be compared with previous radiographs in cm.
|
That mesh will not be fixation
|
Active Comparator: eTEP Mesh Fixation Group
In 30 patients; Inguinal hernia surgery will be performed with the eTEP method and the 15x12x10 cm polyprolene patch used in this surgery will be marked with small metallic clips from the lateral, superomedial and inferomedial sides.
During the surgery, the mesh will be fixed to three absorbable tacker the Cooper ligament, süpermedially and laterally.
Patients whose pain scores (VAS score) are measured on the first postoperative day and who are suitable for discharge will be discharged after a pelvis x-ray is taken.
One month after the surgery and 6 months later, patients will be called to the outpatient clinic and examined, their pain scores will be measured (VAS score) and pelvic radiographs will be taken.
The movement of the clips marked on the patch will be compared with previous radiographs in cm.
|
That mesh will be fixation with three tackers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Status of Mesh Displacement
Time Frame: postoperative 24 hours, 1 and 6 months
|
Patients who are suitable for discharge will be discharged after a pelvis x-ray is taken.
One month after the surgery and 6 months later, patients will be called to the outpatient clinic and examined and pelvic radiographs will be taken.
The movement of the clips marked on the patch will be compared with previous radiographs in cm.
|
postoperative 24 hours, 1 and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Postoperative pain
Time Frame: postoperative 24 hours
|
It will be measured using the Visual Analog Score (VAS).
The patient will be asked to choose between the number 1 with the least pain and the number 10 with the most pain.
The lowest score on this scale is 1, and the highest score is 10.
|
postoperative 24 hours
|
Rate of Postoperative complications
Time Frame: postoperative 24 hours and 1st month
|
such as wound infection, bleeding
|
postoperative 24 hours and 1st month
|
Rate of Hernia recurrence
Time Frame: postoperative 6th month and first year
|
hernia recurrence after six months of follow-up.
It will be checked by physical examination.
Imaging methods will be used in suspicious cases.
|
postoperative 6th month and first year
|
Rate of Chronic pain
Time Frame: postoperative 1st, 6th month and first year
|
It will be measured using the Visual Analog Score (VAS).
The patient will be asked to choose between the number 1 with the least pain and the number 10 with the most pain.
The lowest score on this scale is 1, and the highest score is 10.
|
postoperative 1st, 6th month and first year
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Yildirim MB, Sahiner IT. The effect of mesh fixation on migration and postoperative pain in laparoscopic TEP repair: prospective randomized double-blinded controlled study. Hernia. 2023 Feb;27(1):63-70. doi: 10.1007/s10029-022-02587-w. Epub 2022 Mar 14.
- Claus CMP, Rocha GM, Campos ACL, Paulin JAN, Coelho JCU. Mesh Displacement After Bilateral Inguinal Hernia Repair With No Fixation. JSLS. 2017 Jul-Sep;21(3):e2017.00033. doi: 10.4293/JSLS.2017.00033.
- Claus CM, Rocha GM, Campos AC, Bonin EA, Dimbarre D, Loureiro MP, Coelho JC. Prospective, randomized and controlled study of mesh displacement after laparoscopic inguinal repair: fixation versus no fixation of mesh. Surg Endosc. 2016 Mar;30(3):1134-40. doi: 10.1007/s00464-015-4314-7. Epub 2015 Jun 20.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 65656565
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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