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

Does Inversion and Fixation of the Transversalis Fascia Prevent Postoperative Seroma Formation in Patients Undergoing Laparoscopic Inguinal Hernia Repair?

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.

Study Overview

• Status: Recruiting
• Conditions: Hernia, Inguinal
• Intervention / Treatment: Procedure: Transversalis Fascia Inversion

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34098
      • Recruiting
      • Istanbul Research and Training Hospital
      • Contact: Erol Aydın, MD; Phone Number: +905322546001; Email: erolay@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Group; Patients who underwent transversalis fascia inversion during TEP	Procedure: Transversalis Fascia Inversion; 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.; Other Names: TEP
No Intervention: Control Group; Patients who did not undergo transversalis fascia inversion during TEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroma formation rate	The clinical/radiological seroma formation rates between the groups with and without transversalis fascia inversion and fixation.	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 month
Pain levels	Pain Scores on the Visual Analog Scale at postoperative 7tht day	7 day
Postoperative pain levels	Pain Scores on the Visual Analog Scale at postoperative 1st day	1 day

Collaborators and Investigators

• Sponsor: Istanbul Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2022
• Primary Completion (Anticipated): May 5, 2023
• Study Completion (Anticipated): July 5, 2023

Study Registration Dates

• First Submitted: May 13, 2022
• First Submitted That Met QC Criteria: June 11, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: TEP; Seroma; Inguinal Hernia; Laparoscopic Hernia; Transversalis fascia inversion
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: 2983

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No