Is inguinal hernia repair possible with glue?
| ISRCTN | ISRCTN11368235 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11368235 |
| Protocol serial number | 14186 |
| Sponsor | Medical Canada (Spain) |
| Funder | Medical Canada (Spain) |
- 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
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
Scientific
Primo de Rivera 7, 5ºD
30008. Murcia
Murcia
30008
Spain
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized prospective clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Inguinal hernioplasty: tissue adhesive versus sutures: a randomized clinical trial |
| Study objectives | 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(s) | Ethics committee of Morales Meseguer University Hospital, 17/12/2006 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. Operative time |
| Completion date | 30/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 120 |
| Key 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 |
| Key exclusion criteria | Complicated hernias, bilateral and recurrent hernias |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 30/12/2011 |
Locations
Countries of recruitment
- Spain
Study participating centre
30008
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/09/2016: Plain English summary added.
