search
Back to results

Inversion and Fixation of the Transversalis Fascia in Laparoscopic Inguinal Hernia Repair

Primary Purpose

Hernia, Inguinal

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transversalis Fascia Inversion
Sponsored by
Istanbul Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal focused on measuring Inguinal Hernia, TEP, Seroma, Laparoscopic Hernia, Transversalis fascia inversion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Clinical or/and radiological diagnosis of primary inguinal hernia
  • EHS type M2 and M3 direct hernias
  • Laparoscopic totally extraperitoneal (TEP) repair

Exclusion Criteria:

  • Indirect hernias
  • M1 direct hernias
  • Recurrent hernias
  • Patients with previous groin operations on same side
  • Pregnant women
  • Patients who did not accept to participate in the study
  • ASA score of 3 or higher,

Sites / Locations

  • Istanbul Research and Training HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Active Group

Control Group

Arm Description

Patients who underwent transversalis fascia inversion during TEP

Patients who did not undergo transversalis fascia inversion during TEP

Outcomes

Primary Outcome Measures

Seroma formation rate
The clinical/radiological seroma formation rates between the groups with and without transversalis fascia inversion and fixation.

Secondary Outcome Measures

Chronic pain and quality of life measures
Detect the presence of chronic pain and measuring quality of life after 3 months using the SF-36
Pain levels
Pain Scores on the Visual Analog Scale at postoperative 7tht day
Postoperative pain levels
Pain Scores on the Visual Analog Scale at postoperative 1st day

Full Information

First Posted
May 13, 2022
Last Updated
July 19, 2022
Sponsor
Istanbul Training and Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05420818
Brief Title
Inversion and Fixation of the Transversalis Fascia in Laparoscopic Inguinal Hernia Repair
Official Title
Does Inversion and Fixation of the Transversalis Fascia Prevent Postoperative Seroma Formation in Patients Undergoing Laparoscopic Inguinal Hernia Repair?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
May 5, 2023 (Anticipated)
Study Completion Date
July 5, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
According to the EHS classification, at least 80 patients who will undergo TEP repair for the first time with the diagnosis of M2 and M3 direct inguinal hernia will be randomized into 2 groups. After direct hernia reduction in the patients in the first group, the transversalis fascia at the hernia site will be pulled inward and fixed to the Cooper ligament with 2 or 3 absorbable tackers. Standard surgery will then be continued. The patients in the second group will undergo standard surgery without any seroma prevention procedure. Demographic data, clinical/radiological seroma rate, postoperative pain (VAS values),quality of life(SF36 questionnaire), recurrence and other complications at postoperative 1st, 7th day, 3rd and 6th month will be monitored. When the desired number of patients and the follow-up period are reached, the data in the 2 groups will be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal
Keywords
Inguinal Hernia, TEP, Seroma, Laparoscopic Hernia, Transversalis fascia inversion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Group
Arm Type
Experimental
Arm Description
Patients who underwent transversalis fascia inversion during TEP
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients who did not undergo transversalis fascia inversion during TEP
Intervention Type
Procedure
Intervention Name(s)
Transversalis Fascia Inversion
Other Intervention Name(s)
TEP
Intervention Description
This study will be carried out at SBU Istanbul Training and Research Hospital, General Surgery Clinic. Patients diagnosed with M2 and M3 direct primary inguinal hernia according to EHS classification and who will undergo TEP repair surgery will be randomized into 2 groups. After direct hernia reduction in the patients in the first group, the transversalis fascia at the hernia site will be pulled inward and fixed to the Cooper ligament with 2 or 3 absorbable tackers. Standard surgery will then be continued. The patients in the second group will undergo standard surgery without any seroma prevention procedure. Demographic data of patients in both groups, postoperative pain (VAS values) at postoperative 1st, 7th day and 3rd month, clinical/radiological seroma rate, postoperative pain, QOL, recurrence and other complications will be recorded. When the desired number of patients and follow-up period are reached, the data in the 2 groups will be compared.
Primary Outcome Measure Information:
Title
Seroma formation rate
Description
The clinical/radiological seroma formation rates between the groups with and without transversalis fascia inversion and fixation.
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Chronic pain and quality of life measures
Description
Detect the presence of chronic pain and measuring quality of life after 3 months using the SF-36
Time Frame
3 month
Title
Pain levels
Description
Pain Scores on the Visual Analog Scale at postoperative 7tht day
Time Frame
7 day
Title
Postoperative pain levels
Description
Pain Scores on the Visual Analog Scale at postoperative 1st day
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinical or/and radiological diagnosis of primary inguinal hernia EHS type M2 and M3 direct hernias Laparoscopic totally extraperitoneal (TEP) repair Exclusion Criteria: Indirect hernias M1 direct hernias Recurrent hernias Patients with previous groin operations on same side Pregnant women Patients who did not accept to participate in the study ASA score of 3 or higher,
Facility Information:
Facility Name
Istanbul Research and Training Hospital
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erol Aydın, MD
Phone
+905322546001
Email
erolay@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Inversion and Fixation of the Transversalis Fascia in Laparoscopic Inguinal Hernia Repair

We'll reach out to this number within 24 hrs