Histoacryl™ vs. Suture for Mesh Fixation in Lichtenstein Hernioplasty: A Randomized Prospective Double-Blinded Study (Histoacryl1)

March 1, 2017 updated by: Hospital Plató

Randomized Prospective Double-Blinded Study of Histoacryl™Mesh Fixation Compared to Conventional Non-absorbable Suture Fixation During Lichtenstein Hernioplasty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypothesis:

  1. To use glue (instead of sutures) for mesh fixation during open hernioplasty causes a lower immediate postoperative pain.
  2. The use of Histoacryl is associated to a lower postoperative complications rate.
  3. The use of Histoacryl is not associated to a higher hernia recurrence rate.

Methods:

350 patients with inguinal hernia undergone Lichtenstein operation in day-case surgery setting. Mesh fixation is performed using 2 methods: cyanoacrylate glue: Histoacryl™ (n=175: Group H), and non-absorbable sutures: polypropylene 2/0 (n=175: Group S). Operative time and pain scores, immediate postoperative outcome are followed 1, 7, 30 days and 1 and 5 years postoperatively.

Surgeon doesn't know previously which fixation method will be used in each patient. This method (glue or sutures) is decided intraoperatively, when mesh is placed, using a blind randomization code (www.randomizer.org) Patients are discharged (day-case surgery) if adequate pain control, oral tolerance and spontaneous diuresis is achieved, and after examination by the surgeon in order to discard immediate complications. Postoperative oral treatment is prescribed to patients of both groups: dexketoprofen 25 mg/8 h + paracetamol 1 gr/8.

Follow-up is performed at the medical office by a blind observer (third surgeon) who didn't participate in the surgical procedure, at 1 day, 7 days, 30 days, 1 year and annually thereafter. Pain is measured using a VAS scale (0-10).

Operative data (including operating time, complications, hospital stay, etc.), early and late complications, acute and chronic pain and recurrence rate will be recorded.

Study Type

Interventional

Enrollment (Actual)

370

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08006
        • Hospital Plató

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • unilateral inguinal hernia
  • primary hernia

Exclusion Criteria:

  • femoral hernia
  • recurrent inguinal hernia
  • immunosuppression (including corticosteroids, radiotherapy, chemotherapy)
  • chronic renal failure (hemodialysis)
  • active infection
  • pregnancy
  • allergy to polypropylene
  • patient's refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Histoacryl
Intervention: Lichtenstein Hernioplasty with Histoacryl™(cyanoacrylate glue 0.5 ml) for mesh fixation (Optilene™ mesh 60 g/m2 (B. Braun))
Procedure: Lichtenstein Hernioplasty with Histoacryl

Procedure/Surgery: Lichtenstein Hernioplasty with Histoacryl:

0.5 ml of cyanoacrylate glue is used for mesh fixation
Experimental: Suture
Intervention: Lichtenstein Hernioplasty with Sutures (polypropylene 2/0) to fix the Optilene™ mesh 60 g/m2 (B. Braun)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Postoperative Pain
Time Frame: 30 days
pain scores (VAS 0-10) after surgery
30 days
Operating Time
Time Frame: 30 days
operating time needed to perform hernioplasty
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Complications
Time Frame: 30 days
Complications related to procedure and assessed according to Clavien-Dindo Classification
30 days
Early Recurrence Rate
Time Frame: 1 year
Inguinal hernia recurrence rate after 1 year follow-up
1 year
Chronic Pain
Time Frame: 1 year
Pain scores (0-10) after 1-year follow-up
1 year
Late Recurrence Rate
Time Frame: 5 years
Inguinal hernia recurrence rate after 5 years follow-up
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Plató

Investigators

  • Principal Investigator: Carlos Hoyuela, MD, Hospital Plató

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

December 13, 2015

First Submitted That Met QC Criteria

December 13, 2015

First Posted (Estimate)

December 16, 2015

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Histoacryl1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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