Glyceryltrinitrate in the treatment of haemorrhoids

ISRCTN	ISRCTN95137574
DOI	https://doi.org/10.1186/ISRCTN95137574
Protocol serial number	RBF 97XX8
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Trent (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr John Scholefield
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
Email	john.scholefield@nottingham.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Glyceryltrinitrate
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/08/1998

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

Department of Surgery

Nottingham
NG7 2UH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2003		Yes	No