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

Hernia, Inguinal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05420818
• Other study ID #: 2983
• Status: Recruiting
• Phase: N/A
• Start date: May 5, 2022
• Est. completion date: July 5, 2023

Study information

• Verified date: July 2022
• Source: Istanbul Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 5, 2023
• Est. primary completion date: May 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

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.

Locations

Country	Name	City	State
Turkey	Istanbul Research and Training Hospital	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroma formation rate	The clinical/radiological seroma formation rates between the groups with and without transversalis fascia inversion and fixation.	3 month
Secondary	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
Secondary	Pain levels	Pain Scores on the Visual Analog Scale at postoperative 7tht day	7 day
Secondary	Postoperative pain levels	Pain Scores on the Visual Analog Scale at postoperative 1st day	1 day