Condition category
Circulatory System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
02/10/2014
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

Mr David Mitchell

ORCID ID

Contact details

Department of Vascular Surgery
Southmean Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0106133351

Study information

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

Study hypothesis

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

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.

Study design

Multicentre randomised non-blinded controlled clinical study

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

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

03/10/2003

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Added 13/10/2009:
All patients presenting for open abdominal aortic aneurysm repair

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100 patients undergoing elective aortic aneurysm repair

Participant 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

Recruitment start date

03/10/2003

Recruitment end date

31/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Vascular Surgery
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Gloucestershire Hospitals NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

North Bristol NHS Trust (UK)

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

2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20603858

Publication citations

  1. Results

    Bevis PM, Windhaber RA, Lear PA, Poskitt KR, Earnshaw JJ, Mitchell DC, Randomized clinical trial of mesh versus sutured wound closure after open abdominal aortic aneurysm surgery., Br J Surg, 2010, 97, 10, 1497-1502, doi: 10.1002/bjs.7137.

Additional files

Editorial Notes