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NCT04203940 Clinical Trial

Sutured Versus Cyanoacrylate Glue Mesh Fixation for Inguinal Hernia Repair

Inguinal Hernia Clinical Trial

Official title:
Sutured Versus Cyanoacrylate Glue Mesh Fixation for Inguinal Hernia Repair: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04203940
Other study ID # Mansoura122
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date September 30, 2019

Study information
Verified date December 2019
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Because it avoids direct nerve irritation or entrapment, mesh fixation with tissue adhesive glue seems an optimal option to reduce postoperative pain. Indeed, preliminary results published with different glues all showed promising results with reduced postoperative pain.

This randomized controlled study aimed to compare mesh fixation using N-butyl 2-cyanoacrylate with classical suture fixation in Lichtenstein hernia repair in terms of chronic groin pain, postoperative complications, operative time and recurrence.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date September 30, 2019
Est. primary completion date September 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Patients of both genders aging between 18-65 years with primary unilateral uncomplicated inguinal hernia were included.

Exclusion Criteria:

- Patients with bilateral or sliding inguinal hernia.

- incarcerated or strangulated hernia

- recurrent inguinal hernia

- femoral hernia

- patients unwilling to participate in the trial.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Cyanoacryale
mesh fixation was done using dots of N-butyl 2-cyanoacrylate tissue glue
• Suture
mesh fixation was done with polypropylene 2/0 sutures

Locations
Country Name City State
Egypt Mansoura university hospital Mansourah Dakahlia

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain score at 12 months after surgery Pain assessed by visual pain scale from 0-10 12 months after hernia repair
See also
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