Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417359
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-11
Brief Title:
Comparison of Mesh Fixation and Non-Fixation in eTEP
Sponsor:
Mehmet Eşref Ulutaş
Organization:
Konya City Hospital
Study Overview
Official Title:
Comparison of Mesh Fixation and Non-Fixation in Laparoscopic eTEP Inguinal Hernia Repair
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None