Does the choice of suture material affect outcome in the formulation of an intestinal stoma?
| ISRCTN | ISRCTN08115057 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08115057 |
| Secondary identifying numbers | N0283122687 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 14/03/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Mr William Woods
Scientific
Scientific
Worthing & Southlands Hospitals NHS Trust
Worthing Hospital
Lyndhurst Road
Worthing, West Sussex
BN11 2DH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study hypothesis | Is there any difference in terms of complication rate or ease of use with three of the commonly used sutures for stoma formation? |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Surgery: Laparotomy |
| Intervention | This is a single centre prospective randomized controlled trial comparing the complication rates of vicryl, polydioxanone suture (PDS) or biosyn. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Primary outcome measures are numbers of complications. |
| Secondary outcome measures | Length of hospital stay and time to independence in managing the stoma. |
| Overall study start date | 16/10/2002 |
| Overall study end date | 30/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 90 |
| Participant inclusion criteria | 90 consenting patients due to undergo a laparotomy will be prospectively randomized into three groups. |
| Participant exclusion criteria | Not provided at time of registration |
| Recruitment start date | 16/10/2002 |
| Recruitment end date | 30/10/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Worthing & Southlands Hospitals NHS Trust
Worthing, West Sussex
BN11 2DH
United Kingdom
BN11 2DH
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Sussex NHS Research Consortium (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 |
