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OpenTrials
Completed

NCT Number: NCT04891601

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

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).

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Key information

Age range

16 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • primary hernia
  • male

Exclusion criteria

  • Female
  • bilateral
  • recurrent hernia

Treatment and study plan

polypropelene mesh

Procedure

compare use mesh alone or combined mesh and darn repair

Primary outcomes

  1. Recurrence rate

    Time frame: two to four year

    follow up

  2. Post operative complications

    Time frame: two to four year

    record complication

  3. Post operative pain

    Time frame: two to four year

    Visual Analog Score for pain

Sponsors and collaborators

Lead sponsor

Jabir Ibn Hayyan Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
May 18, 2021
Registry last updated
Jul 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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