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

Sponsor
Istanbul Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05420818
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
14
Anticipated Duration (Months)
5.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transversalis Fascia Inversion
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Does Inversion and Fixation of the Transversalis Fascia Prevent Postoperative Seroma Formation in Patients Undergoing Laparoscopic Inguinal Hernia Repair?
Actual Study Start Date :
May 5, 2022
Anticipated Primary Completion Date :
May 5, 2023
Anticipated Study Completion Date :
Jul 5, 2023

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Seroma formation rate [3 month]

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

    Secondary Outcome Measures

    1. Chronic pain and quality of life measures [3 month]

      Detect the presence of chronic pain and measuring quality of life after 3 months using the SF-36

    2. Pain levels [7 day]

      Pain Scores on the Visual Analog Scale at postoperative 7tht day

    3. Postoperative pain levels [1 day]

      Pain Scores on the Visual Analog Scale at postoperative 1st day

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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,

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istanbul Research and Training Hospital Istanbul Fatih Turkey 34098

    Sponsors and Collaborators

    • Istanbul Training and Research Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Erol Aydın, MD, Istanbul Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT05420818
    Other Study ID Numbers:
    • 2983
    First Posted:
    Jun 15, 2022
    Last Update Posted:
    Jul 21, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Erol Aydın, MD, Istanbul Training and Research Hospital
    Inguinal Hernia
    TEP
    Seroma
    Laparoscopic Hernia
    Transversalis fascia inversion
    Additional relevant MeSH terms:
    Hernia
    Hernia, Inguinal

    Study Results

    No Results Posted as of Jul 21, 2022