Comparison of Whole Mesh and Split Mesh Use in Laparoscopic Inguinal Hernia Repair

Not Applicable

• Conditions: Hernia, Inguinal
• Interventions: Procedure: Split Mesh

• Registration Number: NCT05420376
• Lead Sponsor: Istanbul Training and Research Hospital

Brief Summary

At least 80 patients who will undergo laparoscopic inguinal hernia repair surgery will be randomized into 2 groups. For the patients in the first group, the whole mesh will be laid on the area without being fixed. The patients in the second group will be given a mesh of the same size, but partially divided horizontally and wrapped around the spermatic cord. Demographic data of patients in both groups, quality of life data(Carolinas Comfort Scale) at postoperative 1st, 7th, 30th, 3rd and 6th months, postoperative pain (VAS values), clinical seroma rate, recurrence and other complications will be monitored. When the desired number of patients and follow-up period are reached, the data in the 2 groups will be compared.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-20
• Study First Submitted QC: 2022-06-11
• Study First Posted: 2022-06-15
• Study Start: 2022-06-16
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20
• Primary Completion: 2023-05-16
• Study Completion: 2023-06-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Clinical or/and radiological diagnosed primary inguinal hernia
• TEP or TAPP surgical methods

Exclusion Criteria

• 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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Split Mesh	Split Mesh	The patients in the second group will be given a patch of the same size, but partially divided horizontally and wrapped around the spermatic cord.
Whole Mesh	Split Mesh	For the patients in the first group, the whole patch will be laid on the area without being fixed.

Primary Outcome Measures

Name	Time	Method
Carolinas Comfort Scale values	6 month	Differences in postoperative pain and quality of life(Carolinas Comfort Scale at first month) in patients who use whole meshes and those who use split meshes.
Recurrence rates	6 month	Differences in recurrence rates in patients who use whole meshes and those who use split meshes.

Secondary Outcome Measures

Name	Time	Method
Recurrence rates	6 month	Difference in recurrence rates at 6 months in patients who use whole meshes and those who use split meshes.

Trial Locations

Locations (1)

Istanbul Training and Research Hospital; 🇹🇷 Istanbul, Turkey