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Sutured Versus Cyanoacrylate Glue Mesh Fixation for Inguinal Hernia Repair

NCT ID: NCT04203940

Last Updated: 2019-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cyanoacrylate

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

Group Type ACTIVE_COMPARATOR

Cyanoacryale

Intervention Type PROCEDURE

mesh fixation was done using dots of N-butyl 2-cyanoacrylate tissue glue

Suture

mesh fixation was done with polypropylene 2/0 sutures

Group Type ACTIVE_COMPARATOR

Suture

Intervention Type PROCEDURE

mesh fixation was done with polypropylene 2/0 sutures

Interventions

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Cyanoacryale

mesh fixation was done using dots of N-butyl 2-cyanoacrylate tissue glue

Intervention Type PROCEDURE

Suture

mesh fixation was done with polypropylene 2/0 sutures

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Sameh Emile

lecturer of surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sameh H Emile, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Mansoura122

Identifier Type: -

Identifier Source: org_study_id