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Sutured Versus Cyanoacrylate Glue Mesh Fixation for Inguinal Hernia Repair

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cyanoacryale
Suture
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mansoura university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cyanoacrylate

Suture

Arm Description

mesh fixation was done using dots of N-butyl 2-cyanoacrylate tissue glue (Histoacryl®).

mesh fixation was done with polypropylene 2/0 sutures

Outcomes

Primary Outcome Measures

Pain score at 12 months after surgery
Pain assessed by visual pain scale from 0-10

Secondary Outcome Measures

Full Information

First Posted
December 17, 2019
Last Updated
December 17, 2019
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT04203940
Brief Title
Sutured Versus Cyanoacrylate Glue Mesh Fixation for Inguinal Hernia Repair
Official Title
Sutured Versus Cyanoacrylate Glue Mesh Fixation for Inguinal Hernia Repair: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cyanoacrylate
Arm Type
Active Comparator
Arm Description
mesh fixation was done using dots of N-butyl 2-cyanoacrylate tissue glue (Histoacryl®).
Arm Title
Suture
Arm Type
Active Comparator
Arm Description
mesh fixation was done with polypropylene 2/0 sutures
Intervention Type
Procedure
Intervention Name(s)
Cyanoacryale
Intervention Description
mesh fixation was done using dots of N-butyl 2-cyanoacrylate tissue glue
Intervention Type
Procedure
Intervention Name(s)
Suture
Intervention Description
mesh fixation was done with polypropylene 2/0 sutures
Primary Outcome Measure Information:
Title
Pain score at 12 months after surgery
Description
Pain assessed by visual pain scale from 0-10
Time Frame
12 months after hernia repair

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh H Emile, M.D.
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Sutured Versus Cyanoacrylate Glue Mesh Fixation for Inguinal Hernia Repair

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