Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
08/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Adam L Magos

ORCID ID

Contact details

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

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes