Use of prolene mesh to prevent incisional hernia after elective repair of an abdominal aortic aneurysm
| ISRCTN | ISRCTN28485581 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28485581 |
| Secondary identifying numbers | N0106133351 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 02/10/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr David Mitchell
Scientific
Scientific
Department of Vascular Surgery
Southmean Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Study information
| Study design | Multicentre randomised non-blinded controlled clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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 Previous hypothesis: 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? On 13/10/2009 the sources of funding field was updated. The previous text was 'Gloucestershire R&D Consortium (UK). |
| Ethics approval(s) | 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 Committee (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. |
| Health condition(s) or problem(s) studied | Abdominal aortic aneurysm |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measures as of 13/10/2009: Presence of incisional hernia Previous primary outcome measures: Reduction in post-operative hernia, reduction in number of subsequent hernia repairs |
| Secondary outcome measures | Added 13/10/2009: 1. Duration of surgery 2. Complication rate 3. Re-operation rate |
| Overall study start date | 03/10/2003 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 patients undergoing elective aortic aneurysm repair |
| Key inclusion criteria | Added 13/10/2009: All patients presenting for open abdominal aortic aneurysm repair |
| Key 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 |
| Date of first enrolment | 03/10/2003 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Vascular Surgery
Bristol
BS10 5NB
United Kingdom
BS10 5NB
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Gloucestershire Hospitals NHS Foundation Trust (UK)
No information available
North Bristol NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2010 | Yes | No |
