Mesh Alone VS Combined Mesh and Darn in the Management of Primary Inguinal Hernia in Adult Males

Not Applicable

Completed

• Conditions: Inguinal Hernia
• Interventions: Procedure: polypropelene mesh

• Registration Number: NCT04891601
• Lead Sponsor: Jabir Ibn Hayyan Medical University

Brief Summary

A prospective randomized study involved 228 individuals with primary inguinal hernia, operated in our departments, between January 2015 to February 2018. The duration of hospital stay, operative time, duration of returning to routine activities, postsurgical sequels and recurrence rates estimated. We randomly allocated it into two groups: mesh repair was applied to 166 patients (Group 1) and combined both mesh, and darn repair applied to 162 patients (Group 2).

Detailed Description

Background In spite of the era of laparoscopy still, open repair in primary inguinal hernia is currently the most commonly performed general surgical operation. To evaluate whether the combined darn repair plus Lichtenstein compare Lichtenstein repair alone in the treatment of inguinal hernias regarding postoperative complication and recurrence.

Materials and methods:

A prospective randomized study involved with 218 patients with primary inguinal hernia, operated in our departments, between 2015 and 2018. The duration of the operation time, hospitalization, and time to return to daily activities and postoperative complication and recurrence rates were evaluated. We randomly allocated into two groups: Lichtenstein repair was applied to 169 patients (Group 1), and combined both modified darn repair plus Lichtenstein repair was applied to 160 patients (Group 2).

Results:

The average follow-up period was 48 months. For the alone Lichtenstein procedure, the average duration of operation was 62 min; the average time to return to routine activities was 21 days. The number of patients with postoperative complications was 12 (11.3 %), and the number of patients with recurrence was 1 (0. 9%). For darn repair plus Lichtenstein procedure, the average duration of operation was 72 min; the time to return to daily activities was 21days. The number of patients with postoperative complication was 13 (11.6%), and no recurrences were noted. The hospitalization time of the groups was similar.

Conclusion:

Two-year follow-up, combined mesh and darn better than mesh alone in recurrence rate, both had the same postoperative complication, hospitalization time and return to routine activity.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2018-02
• Study Completion: 2020-02
• Study First Submitted: 2021-03-08
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-13
• Study First Posted: 2021-05-18
• Last Update Submitted: 2021-07-04
• Last Update Posted: 2021-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 228

Inclusion Criteria

• primary hernia
• male

Exclusion Criteria

• Female
• bilateral
• recurrent hernia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II MA Mesh alone repair	polypropelene mesh	patient use mesh alone as treatment of inguinal hernia
Group I CMD Combined Mesh & darn	polypropelene mesh	patients utilize both mesh and darn repair

Primary Outcome Measures

Name	Time	Method
Recurrence rate	two to four year	follow up
Post operative pain	two to four year	Visual Analog Score for pain
Post operative complications	two to four year	record complication