Condition category
Digestive System
Date applied
09/01/2013
Date assigned
29/01/2013
Last edited
20/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
An inguinal hernia occurs when fatty tissue or a part of the bowel pokes through a weak spot in the abdominal wall into the groin, appearing as a swelling or lump. Inguinal hernias can be repaired using surgery to push the bulge back into place. A mesh is placed in the abdominal wall, at the weak spot where the hernia came through, to strengthen it. Tissue adhesives (glues) can be used as an alternative to suture (stitches) for mesh fixation. The aim of this study is to assess the effectiveness of cyanoacrylate glue for hernia repair.

Who can participate?
Patients aged 18 or over with an inguinal hernia

What does the study involve?
Participants are randomly allocated to be treated with either a mesh fixed with sutures or a mesh fixed with glue. Participants are assessed for pain after 7 days, 1, 6 and 12 months, and are examined to see whether the hernia has come back (recurrence) at 2 years after surgery.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Morales Meseguer University Hospital (Spain)

When is the study starting and how long is it expected to run for?
January 2007 to December 2011

Who is funding the study?
Medical Canada (Spain)

Who is the main contact?
Prof. Alfredo Moreno-Egea

Trial website

Contact information

Type

Scientific

Primary contact

Prof Alfredo Moreno-Egea

ORCID ID

Contact details

Primo de Rivera 7
5ºD
30008. Murcia
Murcia
30008
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14186

Study information

Scientific title

Inguinal hernioplasty: tissue adhesive versus sutures: a randomized clinical trial

Acronym

Study hypothesis

Is the adhesive tissue an alternative to the sutures for the inguinal hernioplasty? The use of tissue adhesives can be an alternative to suture fixation of the mesh, but their experience is very limited.

Ethics approval

Ethics committee of Morales Meseguer University Hospital, 17/12/2006

Study design

Randomized prospective clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Inguinal hernia

Intervention

Group 1 Lichtenstein operation (mesh fixed with sutures) and Group 2 mesh fixed with glue.
The synthetic adhesive is n-hexyl-á-cyanoacrylate

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Pain and recurrence. Patients were assessed for pain at 7 days, 1, 6 and 12 months using a visual analogue scale with a range from 0-10, and were examined clinically for recurrence at 2 year after surgery.

Secondary outcome measures

1. Operative time
2. Analgesic consumption
3. Hematoma
4. Infection

Overall trial start date

01/01/2007

Overall trial end date

30/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with inguinal hernia not complicated
2. Patients (male and female) who were at least 18 years old and presented at the Abdominal Wall Unit of Morales Meseguer University Hospital of Murcia with a diagnosis of an inguinal hernia

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

Complicated hernias, bilateral and recurrent hernias

Recruitment start date

01/01/2007

Recruitment end date

30/12/2011

Locations

Countries of recruitment

Spain

Trial participating centre

Morales Meseguer University Hospital
Murcia
30008
Spain

Sponsor information

Organisation

Medical Canada (Spain)

Sponsor details

Poligono Industrial
San Gines
Murcia
30500
Spain

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Medical Canada (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

20/09/2016: Plain English summary added.