Intra-operative application of glycerine trinitrate (GTN) in anterior resection and pouch construction
| ISRCTN | ISRCTN28484577 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28484577 |
| Secondary identifying numbers | N0265109328 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 16/09/2014
- 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 of protocol
Not provided at time of registration
Contact information
Dr MRB Keighley
Scientific
Scientific
GI Surgery
Queen Elizabeth Hospital
Birmingham
B15 2TH
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 objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: anterior resection and pouch construction |
| Intervention | We should recruit 40 consenting patients in each group (AR and IPAA) to be randomly assigned to receive a single perioperative dose of topical 0.2% GTN (glycerine trinitrate) ointment or nothing. All patients to be assessed pre- and post-operatively with a clinical incontinence assessment, anorectal manometry and transanal ultrasound. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Glycerine trinitrate |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 08/06/2002 |
| Completion date | 08/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 80 |
| Key inclusion criteria | All patients submit to anterior resection (AR) and ileal pouch-anal anastomosis (IPAA) |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 08/06/2002 |
| Date of final enrolment | 08/06/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
GI Surgery
Birmingham
B15 2TH
United Kingdom
B15 2TH
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
University Hospital Birmingham 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 |
