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Histoacryl™ vs. Suture for Mesh Fixation in Lichtenstein Hernioplasty: A Randomized Prospective Double-Blinded Study

NCT02632097 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2017-03-03

No results posted yet for this study

Summary

This is a prospective, randomized double-blinded study to find out if mesh fixation with n-butyl-2-cyanoacrylate (NBCA) are more painless than conventional mesh fixation with sutures in inguinal hernia operation (Lichtenstein procedure) in day-case surgery. Our hypothesis is that glue fixation is safe, simple and fast method compared to conventional Lichtenstein technique.

Conditions

  • Inguinal Hernia

Interventions

PROCEDURE

Lichtenstein Hernioplasty with Histoacryl

Procedure/Surgery: Lichtenstein Hernioplasty with Histoacryl: 0.5 ml of cyanoacrylate glue is used for mesh fixation

PROCEDURE

Lichtenstein Hernioplasty with Sutures

Procedure/Surgery: Lichtenstein Hernioplasty with Sutures: non-absorbable suture (polypropylene 2/0) is used for mesh fixation Other Name: prolene 2-0

Sponsors & Collaborators

  • Hospital Plató

    lead OTHER

Principal Investigators

  • Carlos Hoyuela, MD · Hospital Plató

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2016-12-31
Completion
2017-01-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02632097 on ClinicalTrials.gov