Glyceryltrinitrate in the treatment of haemorrhoids
| ISRCTN | ISRCTN95137574 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95137574 |
| Secondary identifying numbers | RBF 97XX8 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 16/11/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive 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 John Scholefield
Scientific
Scientific
Department of Surgery
University of Nottingham
E Floor
West Block
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 (0)115 970 9245 |
|---|---|
| john.scholefield@nottingham.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The proposed study will examine: 1. The physiology of anal canal mucosal blood flow and its relationship to pressures in the anal canal in patients with 1st and 2nd degree haemorrhoids compared to patients without disease 2. The effects of topical GTN formulations on anal canal pressure and its relationship to mucosal blood flow in the anal canal and in particular in 1st and 2nd degree haemorrhoids 3. The efficacy of treatment with GTN topical formulations compared to sclerotherapy or band ligation for 1st and 2nd degree haemorrhoids in a randomised trial 4. The delivery of topically applied GTN from novel formulations preparations and its optimisation |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Haemorrhoids |
| Intervention | Not provided at time of registration |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Glyceryltrinitrate |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/1997 |
| Completion date | 31/08/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 200 |
| Key inclusion criteria | 200 patients with 1st or 2nd degree haemorrhoidal disease attending the colorectal unit outpatient clinic. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/1997 |
| Date of final enrolment | 31/08/1998 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Surgery
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Trent (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 | 01/02/2003 | Yes | No |
