Condition category
Digestive System
Date applied
12/04/2015
Date assigned
24/06/2015
Last edited
24/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Miss Lucia Latorre

ORCID ID

http://orcid.org/0000-0002-7929-8609

Contact details

Maestro Vives 2
Madrid
28009
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CIRESP-15-34

Study information

Scientific title

Randomised clinical trial comparing low density versus high density meshes in patients with
bilateral inguinal hernia

Acronym

Study hypothesis

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

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.

Study design

Randomised prospective interventional clinical trial single-centre

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/02/2006

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

67

Participant 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

Recruitment start date

22/02/2006

Recruitment end date

19/06/2008

Locations

Countries of recruitment

Spain

Trial participating centre

The Santa Cristina University Hospital (Hospital Universitario Santa Cristina)
Maestro Vives 2
Madrid
28009
Spain

Sponsor information

Organisation

The Santa Cristina University Hospital (Hospital Universitario Santa Cristina)

Sponsor details

Maestro Vives 2
Madrid
28009
Spain

Sponsor type

Hospital/treatment centre

Website

www.madrid.org/hospitalsantacristina

Funders

Funder type

Hospital/treatment centre

Funder name

The Santa Cristina University Hospital (Hospital Universitario Santa Cristina) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication in peer-reviewed journal Spanish Surgery (Cirugía Española).

Intention to publish date

01/05/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes