|
ISRCTN
|
ISRCTN28485581
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Use of prolene mesh to prevent incisional hernia after elective repair of an abdominal aortic aneurysm
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0106133351
|
|
Study hypothesis
|
Does the use of the routine placement of prolene mesh into patients undergoing elective abdominal aortic aneurysm repair reduce the number of postoperative incisional hernias?
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Cardiovascular: Abdominal aortic aneurysm
|
|
Participants - inclusion criteria
|
Not provided at time of registration
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
03/10/2003
|
|
Anticipated end date
|
31/12/2006
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
100 patients undergoing elective aortic aneurysm repair
|
|
Interventions
|
1. Routine mass closure with nylon sutures (standard)
2. Abdominal closure using polypropylene
|
|
Primary outcome measure(s)
|
Reduction in postoperative hernia, reduction in number of subsequent hernia repairs
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Gloucestershire R&D Consortium (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Mr
Jonathan
Earnshaw
|
|
Address
|
Consultant Surgeon
Gloucestershire Royal Hospital
Great Western Road
|
|
City/town
|
Gloucester
|
|
Zip/Postcode
|
GL1 3NN
|
|
Country
|
United Kingdom
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
|
|
Address
|
The Department of Health, Richmond House, 79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
30/09/2004
|
|
Last edited
|
27/03/2008
|
|
Date ISRCTN assigned
|
30/09/2004
|
