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21 May 2012
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| [ Print-friendly version ] |
| Use of prolene mesh to prevent incisional hernia after elective repair of an abdominal aortic aneurysm |
| 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 | Mesh abdominal aortic aneurysm (AAA) Repair Trial: a randomised prospective controlled trial studying the use of prolene mesh in the abdominal wound closure of patients undergoing standard AAA repair |
| Acronym | N/A |
| Serial number at source | N0106133351 |
| Study hypothesis |
Please note that as of 13/10/2009 this record was extensively updated to include changes to the protocol. All changes can be found under the relevant section with the above update date. At this time, the contact details were also updated.
Current hypothesis as of 13/10/2009: Incisional hernia is a significant problem following standard open AAA repair, occurring in about 1/3 of patients undergoing this procedure. Placement of a prolene mesh between the posterior rectus sheath/anterior peritoneum and the rectus muscle has been shown in a small feasibility study to be a safe technique for abdominal wound reinforcement during standard open AAA repair and appeared to prevent hernia occurrence. It is the aim of this prospective randomised controlled trial to: 1. Provide robust evidence of differences in hernia rates between standard and mesh closure techniques 2. Compare complication rates between the two groups 3. Give clear indication based on the above evidence as to whether this technique should be used routinely for the closure of all abdominal wounds following standard open AAA repair Initial hypothesis at time of registration: Does the use of the routine placement of prolene mesh into patients undergoing elective abdominal aortic aneurysm repair reduce the number of post-operative incisional hernias? |
| Lay summary | |
| Ethics approval |
Added 13/10/2009:
Initial ethics approval was obtained from the Gloucestershire Research Ethics Committee (ref: 04/Q2005/33) and subsequently extended to North Bristol NHS Trust via Frenchay Research Ethics Committe (ref: S105/03). The Gloucestershire REC has now closed and all enquiries are now handled by Frenchay REC, Pembroke Room, Beaufort House, Southmead Hospital, Westbury-on-Trym, Bristol, BS10 5NB. It was fully approved in July 2004. |
| Study design | Multicentre randomised non-blinded controlled clinical study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Abdominal aortic aneurysm |
| Participants - inclusion criteria |
Added 13/10/2009:
All patients presenting for open abdominal aortic aneurysm repair |
| Participants - exclusion criteria |
Added 13/10/2009:
1. Inability to give written informed consent 2. Condition predisposing to infection, including immuno-compromise or faecal contamination/soiling but not including diabetes mellitus |
| Anticipated start date | 03/10/2003 |
| Anticipated end date | 31/12/2006 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 Added 13/10/2009: Follow-up at 1, 3, 6, 12, 24 and 36 months post-surgery. Initial contact details at time of registration: Mr Jonathan Earnshaw Gloucester Royal Hospital |
| Primary outcome measure(s) |
Current as of 13/10/2009:
Presence of incisional hernia Initial information at time of registration: Reduction in post-operative hernia, reduction in number of subsequent hernia repairs |
| Secondary outcome measure(s) |
Added 13/10/2009:
1. Duration of surgery 2. Complication rate 3. Re-operation rate |
| Sources of funding |
Current as of 13/10/2009:
1. Gloucestershire Hospitals NHS Foundation Trust (UK) 2. North Bristol NHS Trust (UK) Initial information at time of registration: Gloucestershire R&D Consortium (UK) |
| Trial website | |
| Publications | 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20603858 |
| Contact name | Mr David Mitchell |
| Address |
Department of Vascular Surgery
Southmean Hospital Westbury-on-Trym |
| City/town | Bristol |
| Zip/Postcode | BS10 5NB |
| 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 |
| dhmail@doh.gsi.org.uk | |
| Sponsor website: | http://www.dh.gov.uk/Home/fs/en |
| Date applied | 30/09/2004 |
| Last edited | 05/11/2010 |
| Date ISRCTN assigned | 30/09/2004 |
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