NCT05420818

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?

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Istanbul Training and Research Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hernia, Inguinal

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-05-05
• Primary completion: 2023-05-05
• Completion: 2023-07-05
• First posted: 2022-06-15
• Last updated: 2022-07-21

Locations

1 site across 1 country: Turkey (Türkiye)