Condition category
Digestive System
Date applied
22/08/2009
Date assigned
22/10/2009
Last edited
03/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vicente Vicente

ORCID ID

Contact details

General Surgery Department
University Hospital Joan XXIII de Tarragona
C/ Dr. Mallafre Guasch nº 4
Tarragona
43007
Spain
-
drvicentevicente@hotmail.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Efficacy evaluation of a low weight prosthetic mesh in the prevention of incisional hernia in patients undergoing medial laparotomy surgery: a prospective randomised single-blind parallel group single centre trial

Acronym

Study hypothesis

Placemet of a low weight prosthetic mesh can prevent or reduce the ocurrence of incisional hernia in patients requiring medial laparotomy surgery.

Ethics approval

Ethics Committee of the University Hospital Joan XXIII Tarragona, 27/04/2009

Study design

Prospective randomised simple blind parallel group single centre 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

Incisional hernia

Intervention

Intervention group: At the end of the surgery we close the abdominal fascia with a continuous suture and a low weight polypropilene prosthetic mesh is placed 3 cm above the end zone attached to the aponeurosis with continous sutures.
Control group: At the end of the surgery we close the abdominal fascia with a continuous suture only.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Physical exploration in series controls, in one week, one month, three months, six months, one year and two years
2. Computed tomography (CT) scan in doubt cases

Secondary outcome measures

36-item short form health survey (SF-36) quality of life test at baseline, one month, six months and one year

Overall trial start date

01/05/2009

Overall trial end date

01/05/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients aged between 18 and 80 years, both sexes, requiring digestive surgery in our hospital, by a medial laparotomy
2. American Society of Anaesthesiology (ASA) less than grade IV

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

71 patients in the control group and 71 patients in the mesh group

Participant exclusion criteria

1. Allergic to polypropilene
2. Previous prosthetic mesh for a previous incisional hernia
3. Any ostomy in the abdominal wall
4. ASA greater than or equal to grade 4
5. Living prognosis less than 12 months
6. Corticotherapy
7. Haemodialysis

Recruitment start date

01/05/2009

Recruitment end date

01/05/2013

Locations

Countries of recruitment

Spain

Trial participating centre

University Hospital Joan XXIII de Tarragona
Tarragona
43007
Spain

Sponsor information

Organisation

University Hospital Joan XXIII de Tarragona (Spain)

Sponsor details

General Surgery Department
Dr. Mallafre Guasch nº 4
Tarragona
43007
Spain

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Joan XXIII de Tarragona (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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25087939 (retracted)
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24663481

Publication citations

Additional files

Editorial Notes