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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25087939 (retracted)
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24663481