Condition category
Not Applicable
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
13/07/2009
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 & Gynaecology
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0256130918

Study information

Scientific title

Acronym

Study hypothesis

To determine whether women who undergo traditional hysteroscopy experience more discomfort during hysteroscopy compared to women who undergo no touch hysteroscopy

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

Diagnostic

Patient information sheet

Condition

Not Applicable: Hysteroscopy

Intervention

Women were randomised to undergo either traditional saline hysteroscopy requiring the use of a speculum and tenaculum, or a 'no-touch' vaginoscopic hysteroscopy which does not require a speculum or tenaculum. Each group was further subdivided to have hysteroscopy with either a 2.9-mm or 4-mm hysteroscope. Patients were asked to complete pre- and postprocedure questionnaires ranking pain scores.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Service outcome development

Secondary outcome measures

Not provided at time of registration

Overall trial start date

21/10/2003

Overall trial end date

31/10/2004

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

21/10/2003

Recruitment end date

31/10/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Department of Obstetrics & Gynaecology
London
NW3 2QG
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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)

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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15958000

Publication citations

  1. Results

    Sharma M, Taylor A, di Spiezio Sardo A, Buck L, Mastrogamvrakis G, Kosmas I, Tsirkas P, Magos A, Outpatient hysteroscopy: traditional versus the 'no-touch' technique., BJOG, 2005, 112, 7, 963-967, doi: 10.1111/j.1471-0528.2005.00425.x.

Additional files

Editorial Notes