NCT04203940

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2019

Completed
Last Updated

December 18, 2019

Status Verified

December 1, 2019

Enrollment Period

7 months

First QC Date

December 17, 2019

Last Update Submit

December 17, 2019

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • Pain score at 12 months after surgery

    Pain assessed by visual pain scale from 0-10

    12 months after hernia repair

Study Arms (2)

Cyanoacrylate

ACTIVE COMPARATOR

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

Procedure: Cyanoacryale

Suture

ACTIVE COMPARATOR

mesh fixation was done with polypropylene 2/0 sutures

Procedure: Suture

Interventions

CyanoacryalePROCEDURE

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

Cyanoacrylate
SuturePROCEDURE

mesh fixation was done with polypropylene 2/0 sutures

Suture

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with bilateral or sliding inguinal hernia.
  • incarcerated or strangulated hernia
  • recurrent inguinal hernia
  • femoral hernia
  • patients unwilling to participate in the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Sutures

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Sameh H Emile, M.D.

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of surgery

Study Record Dates

First Submitted

December 17, 2019

First Posted

December 18, 2019

Study Start

March 1, 2018

Primary Completion

September 30, 2018

Study Completion

September 30, 2019

Last Updated

December 18, 2019

Record last verified: 2019-12

Locations

EG(1)