Low density versus high density meshes in patients with bilateral inguinal hernia
| ISRCTN | ISRCTN81349560 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81349560 |
| Secondary identifying numbers | CIRESP-15-34 |
- Submission date
- 12/04/2015
- Registration date
- 24/06/2015
- Last edited
- 24/06/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
A hernia can occur when a weak spot in the muscle or tissue lets an internal part of the body such as the intestines push through. An inguinal hernia occurs in the groin region when fatty tissue or a part of the bowel bulges through into your groin at the top of the inner thigh. When this happens on both sides of the groin it is called a bilateral inguinal hernia. Surgery can be used to push the bulge back into place and a surgical mesh is often used to strengthen the surrounding tissue. There are two types of mesh most often used in surgery to treat hernias. One is lightweight, and the other is heavyweight. The aim of this study is to see whether there is a difference in patients’ experience of pain and surgical complications depending on which type of mesh is used to treat their bilateral inguinal hernia.
Who can participate?
Adults over 18 undergoing surgery for bilateral inguinal hernia.
What does the study involve?
All participants are given a lightweight mesh and a heavyweight mesh. One mesh will treat one side of the hernia, and the other mesh will treat the other side; which side gets what mesh is allocated randomly. Questionnaires about pain and health related to the surgery are completed on the 1st, 3rd, 5th, and 7th day after surgery and, finally, one year after surgery.
What are the possible benefits and risks of participating?
Both type of meshes are approved and commonly used in medical practice and their use does not carry additional risk.
Where is the study run from?
The Santa Cristina University Hospital (Hospital Universitario Santa Cristina) (Spain)
When is the study starting and how long is it expected to run for?
May 2006 to June 2008
Who is funding the study?
The Santa Cristina University Hospital (Hospital Universitario Santa Cristina) (Spain)
Who is the main contact?
Miss L Latorre
Contact information
Scientific
Maestro Vives 2
Madrid
28009
Spain
 ORCID ID |
0000-0002-7929-8609 |
|---|
Study information
| Study design | Randomised prospective interventional clinical trial single-centre |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Randomised clinical trial comparing low density versus high density meshes in patients with bilateral inguinal hernia |
| Study objectives | There is a difference in patient-report of postoperative pain, feeling of a foreign body, postoperative complications, and recurrence of hernia in patients following surgery for bilateral inguinal hernia using either lightweight or heavyweight mesh. |
| Ethics approval(s) | This study does not require ethics approval. We compare two meshes that are frequently used in inguinal hernia repair and these are approved for use. |
| Health condition(s) or problem(s) studied | Bilateral inguinal hernia |
| Intervention | Lightweight mesh is randomly allocated to patients for use on one side of a bilateral hernia. The more frequently used heavyweight mesh is used on the other side. The side receiving the lightweight mesh is selected using a random numbers table. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Outcomes measured on 1st, 3rd, 5th and 7th postoperative day, and one year after surgery: 1. Postoperative pain measured by visual analogue scale 2. Complications following procedure comparing lightweight mesh and heavyweight mesh 3. Self-reported feeling of a foreign body following surgery 4. Recurrence of bilateral inguinal hernia comparing lightweight mesh and heavyweight mesh |
| Secondary outcome measures | There are no secondary outcome measures. |
| Overall study start date | 01/02/2006 |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 67 |
| Key inclusion criteria | 1. Age >18 2. No significant comorbidity 3. Clinical symmetrical hernias 4. Simple non-recurrent hernias 5. No associated femoral hernia 6. Participant consent |
| Key exclusion criteria | 1. Age <18 years 2. Senior patients with significant comorbidity 3. Clinically asymmetrical hernias 4. Recurrent hernias 5. Complicated hernias (incarceration or strangulation) 6. Presence of associated femoral hernia 7. Patient cannot give consent |
| Date of first enrolment | 22/02/2006 |
| Date of final enrolment | 19/06/2008 |
Locations
Countries of recruitment
- Spain
Study participating centre
Madrid
28009
Spain
Sponsor information
Hospital/treatment centre
Maestro Vives 2
Madrid
28009
Spain
| Website | www.madrid.org/hospitalsantacristina |
|---|---|
"ROR" |
https://ror.org/01bynmm24 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/05/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication in peer-reviewed journal Spanish Surgery (Cirugía Española). |
| IPD sharing plan |
