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
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list