Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0256159467
Study information
Scientific title
A randomised controlled trial of outpatient hysteroscopy looking at the effects of temperature and pressure
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
Service outcome development
Secondary outcome measures
Not provided at time of registration
Overall trial start date
15/07/2003
Overall trial end date
15/07/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
120 patients
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
120
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
15/07/2003
Recruitment end date
15/07/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Department Of Obstetrics and Gynaecology
London
NW3 2QG
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
The Royal Free Hampstead NHS Trust (UK) NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list