Inversion and Fixation of the Transversalis Fascia in Laparoscopic Inguinal Hernia Repair
NCT ID: NCT05420818
Last Updated: 2022-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2022-05-05
2023-07-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active Group
Patients who underwent transversalis fascia inversion during TEP
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.
Control Group
Patients who did not undergo transversalis fascia inversion during TEP
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* EHS type M2 and M3 direct hernias
* Laparoscopic totally extraperitoneal (TEP) repair
Exclusion Criteria
* 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,
18 Years
ALL
Yes
Sponsors
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Istanbul Training and Research Hospital
OTHER_GOV
Responsible Party
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Erol Aydın
MD
Locations
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Istanbul Research and Training Hospital
Istanbul, Fatih, Turkey (Türkiye)
Countries
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Facility Contacts
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Other Identifiers
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2983
Identifier Type: -
Identifier Source: org_study_id
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