Intra-operative application of glycerine trinitrate (GTN) in anterior resection and pouch construction
| ISRCTN | ISRCTN28484577 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28484577 |
| Protocol serial number | N0265109328 |
| Sponsor | Department of Health (UK) |
| Funder | University Hospital Birmingham NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Glycerine trinitrate |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 08/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
GI Surgery
Birmingham
B15 2TH
United Kingdom
B15 2TH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
