A randomised controlled trial of outpatient hysteroscopy looking at the effects of temperature and pressure

ISRCTN	ISRCTN62284430
DOI	https://doi.org/10.1186/ISRCTN62284430
Secondary identifying numbers	N0256159467

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

Dr Adam L Magos
Scientific

University Department Of Obstetrics and Gynaecology
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised controlled trial of outpatient hysteroscopy looking at the effects of temperature and pressure
Study objectives	To determine whether women who undergo hysteroscopy experience more discomfort when there is a change in pressure and temperature of the saline used to distend the endometrial cavity
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Hysteroscopy
Intervention	Randomised controlled trial: 1. Normal saline, 37degree celsius, 150 mmHg 2. Normal saline, room temperature 100mmHg 3. Normal saline, room temperature, 200 mmHg 4. Saline, room temperature, 150 mmHg
Intervention type	Procedure/Surgery
Primary outcome measure	Service outcome development
Secondary outcome measures	Not provided at time of registration
Overall study start date	15/07/2003
Completion date	15/07/2004

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	120
Key inclusion criteria	120 patients
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	15/07/2003
Date of final enrolment	15/07/2004

University Department Of Obstetrics and Gynaecology

London
NW3 2QG
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Hospital/treatment centre

The Royal Free Hampstead NHS Trust (UK) NHS R&D Support Funding

No information available

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

18/10/2017: No publications found in PubMed, verifying study status with principal investigator.