ISRCTN ISRCTN11368235
DOI https://doi.org/10.1186/ISRCTN11368235
Secondary identifying numbers 14186
Submission date
09/01/2013
Registration date
29/01/2013
Last edited
20/09/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Alfredo Moreno-Egea
Scientific

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

Study information

Study designRandomized prospective clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleInguinal hernioplasty: tissue adhesive versus sutures: a randomized clinical trial
Study objectivesIs 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(s)Ethics committee of Morales Meseguer University Hospital, 17/12/2006
Health condition(s) or problem(s) studiedInguinal hernia
InterventionGroup 1 Lichtenstein operation (mesh fixed with sutures) and Group 2 mesh fixed with glue.
The synthetic adhesive is n-hexyl-á-cyanoacrylate
Intervention typeProcedure/Surgery
Primary outcome measurePain 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 measures1. Operative time
2. Analgesic consumption
3. Hematoma
4. Infection
Overall study start date01/01/2007
Completion date30/12/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants120
Key inclusion criteria1. 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
Key exclusion criteriaComplicated hernias, bilateral and recurrent hernias
Date of first enrolment01/01/2007
Date of final enrolment30/12/2011

Locations

Countries of recruitment

  • Spain

Study participating centre

Morales Meseguer University Hospital
Murcia
30008
Spain

Sponsor information

Medical Canada (Spain)
Hospital/treatment centre

Poligono Industrial
San Gines
Murcia
30500
Spain

ROR logo "ROR" https://ror.org/011xgdn77

Funders

Funder type

Industry

Medical Canada (Spain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

20/09/2016: Plain English summary added.