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

Istanbul Training and Research Hospital

Status: Enrolling

Conditions: Hernia, Inguinal

Treatments: Procedure: Transversalis Fascia Inversion

Study type: Interventional

Funder types: Other

Identifiers

NCT05420818

2983

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Active Group

Experimental group

Description:

Patients who underwent transversalis fascia inversion during TEP

Treatment:

Procedure: Transversalis Fascia Inversion

Control Group

No Intervention group

Description:

Patients who did not undergo transversalis fascia inversion during TEP