Changing the Innate Consensus About Mesh Fixation in Trans-abdominal Preperitoneal Laparoscopic Inguinal Hernioplasty in Adults: Short and Long Term Outcome. Randomized Controlled Clinical Trial

NCT04272424 | Completed

• 1 other identifier: zagazig university 3
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: Inguinal hernioplasty is the standard treatment for inguinal hernia. Mesh fixation is used to keep mesh in place for which various mesh fixation techniques have been used in laparoscopic inguinal hernia repair, but their effectiveness has remained inconclusive. Aim of the work: Randomized comparative study comparing early and late outcome of different method of mesh fixation. Methods: In Zagazig University Hospitals, over the period from July 2016 to July 2018, patients with with oblique inguinal hernias undergoing Tans abdominal preperitoneal technique were randomized into 3 groups: Group A; mesh non fixation . Group B; tacker mesh fixation Group C: Cyanoacrylic tissue glues (Histoacryl) mesh fixation Clinical effects were assessed by the following variables: intraoperative data, postoperative outcome as regard recurrence rate, postoperative complications, analgesic consumption, operation time, hospital stay, and patient costs. Follow up was 18 months.

Conditions

Hernia, Inguinal

Outcome Measures

Primary Outcomes (1)

• pain following lap hernioplasty with different method of fixation

  pain on visual analogue score

  1.5 years

Secondary Outcomes (1)

• recurrence of the disease following lap hernioplasty with different method of mesh fixation

  1.5 years

Study Arms (3)

group A

ACTIVE COMPARATOR

laparoscopic hernioplasty with no fixation

Procedure: laparoscopic mesh fixation

group B

ACTIVE COMPARATOR

laparoscopic hernioplasty with tacker fixation

Procedure: laparoscopic mesh fixation

group C

ACTIVE COMPARATOR

laparoscopic hernioplasty with histoacryl fixation

Procedure: laparoscopic mesh fixation

Interventions

laparoscopic mesh fixation PROCEDURE

laparoscopic mesh fixation by non fixation,tacker and histoacryl

group A; group B; group C

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ranging from 20 to 50
• Both sex
• An uncomplicated oblique inguinal hernia.
• Unilateral hernia

You may not qualify if:

• Patients younger than 20 or older than 50 year old
• Patients with complicated hernia
• Bilateral hernia
• Recurrent hernia
• Patients with previous lower abdominal surgery.

Sponsors & Collaborators

• Zagazig University: lead

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• tamer A. alnaimy, MD

  Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professour

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 17, 2020
• Study Start: July 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share