Sutured Versus Cyanoacrylate Glue Mesh Fixation for Inguinal Hernia Repair

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

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.

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia
• Intervention / Treatment: Procedure: Cyanoacryale; Procedure: Suture

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansourah, Dakahlia, Egypt, 35516
      • Mansoura University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Cyanoacrylate; mesh fixation was done using dots of N-butyl 2-cyanoacrylate tissue glue (Histoacryl®).	Procedure: Cyanoacryale; mesh fixation was done using dots of N-butyl 2-cyanoacrylate tissue glue
ACTIVE_COMPARATOR: Suture; mesh fixation was done with polypropylene 2/0 sutures	Procedure: Suture; mesh fixation was done with polypropylene 2/0 sutures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score at 12 months after surgery	Pain assessed by visual pain scale from 0-10	12 months after hernia repair

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2018
• Primary Completion (ACTUAL): September 30, 2018
• Study Completion (ACTUAL): September 30, 2019

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (ACTUAL): December 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: Mansoura122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No