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

Sponsor

Jabir Ibn Hayyan Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT04891601

Collaborator

(none)

228

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Inguinal Hernia	Procedure: polypropelene mesh	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

228 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomised Controlled Trial, Compare Mesh and Combined Mesh and Darn Repair in the Treatment of Adults Inguinal Hernia

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Feb 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group II MA Mesh alone repair patient use mesh alone as treatment of inguinal hernia	Procedure: polypropelene mesh compare use mesh alone or combined mesh and darn repair
Active Comparator: Group I CMD Combined Mesh & darn patients utilize both mesh and darn repair	Procedure: polypropelene mesh compare use mesh alone or combined mesh and darn repair

Arm

Intervention/Treatment

Active Comparator: Group II MA Mesh alone repair

patient use mesh alone as treatment of inguinal hernia

Procedure: polypropelene mesh

compare use mesh alone or combined mesh and darn repair

Active Comparator: Group I CMD Combined Mesh & darn

patients utilize both mesh and darn repair

Procedure: polypropelene mesh

compare use mesh alone or combined mesh and darn repair

Outcome Measures

Primary Outcome Measures

Recurrence rate [two to four year]
follow up
Post operative complications [two to four year]
record complication
Post operative pain [two to four year]
Visual Analog Score for pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

primary hernia
male

Exclusion Criteria:

Female
bilateral
recurrent hernia

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Jabir Ibn Hayyan Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jabir Ibn Hayyan Medical University

ClinicalTrials.gov Identifier:

NCT04891601

Other Study ID Numbers:

Hernia

First Posted:

May 18, 2021

Last Update Posted:

Jul 7, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jabir Ibn Hayyan Medical University

Adult inguinal hernia

Mesh

Darn repair

Hernia repair techinques

Primary inguinal hernia

Additional relevant MeSH terms:

Hernia

Hernia, Inguinal

Study Results

No Results Posted as of Jul 7, 2021