Condition category
Surgery
Date applied
02/12/2011
Date assigned
19/12/2011
Last edited
16/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Outpatient diagnostic hysteroscopy is an endoscopic examination of the inside of the womb. In order to visualise inside the womb, a clear fluid is usually administered under pressure (100 mmHg) to distend the cavity of the womb. This study aims to establish if lower filling pressures can be used to visualise inside the womb and whether this may reduce the level of pain the woman experiences.

Who can participate?
All women who are due to undergo an outpatient hysteroscopy procedure in Gynaecology Outpatients Department of the University College London Hospitals (UK) and are able to give informed consent are invited to take part in this trial.

What does the study involve?
The women will be randomly allocated to three different level of filling pressure (100, 70 or 40 mmHg) and they and the assessor will not know which pressure level is used (this is called blinding). The assessor will judge whether the visualisation was adequate or inadequate and the woman will be asked to score the level of pain she experienced during the procedure. If the visualisation is inadequate, then the standard filling pressure of 100 mmHg will be used to complete the procedure.

What are the possible benefits and risks of participating?
There are no additional risks. The only risks involved will of those related to the outpatient hysteroscopy procedure itself. They include infection, bleeding and uterine perforation (making a hole in the wall of the womb) and are very rare.

Where is the study run from?
The study is carried out at the Gynaecology Outpatients Department of the University College London Hospitals (UK).

When is the study starting and how long is it expected to run for?
The study started in March 2007. We aim to recruit 230 women in total and we anticipate that the recruitment will be completed in early 2012.

Who is funding the study?
The study is sponsored by the University College London Hospitals NHS Foundation Trust (UK).

Who is the main contact?
Mr Ertan Saridogan, Consultant Gynaecologist
ertan.saridogan@uclh.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Ertan Saridogan

ORCID ID

Contact details

Women's Health Division
University College London Hospitals
250 Euston Road
London
NW1 2PG
United Kingdom
+44 20 3447 9759
ertan.saridogan@uclh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

06/0112

Study information

Scientific title

Optimum intrauterine filling pressures needed to perform outpatient diagnostic hysteroscopy: a double-blind randomised trial

Acronym

Study hypothesis

The filling pressures used to perform outpatient diagnostic hysteroscopy can be reduced without compromising the visualisation of uterine cavity and this may reduce the pain experienced by the woman

Ethics approval

The Joint UCL/UCLH Committes on the Ethics of Human Research, 28 September 2006, ref: 06/Q0502/69

Study design

Double blind randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information leaflet

Condition

Hysteroscopy

Intervention

Women who are due to undergo an outpatient hysteroscopy procedure will be recruited after obtaining informed consent. They will be allocated to one of the three pressure groups (100mmHg, 70mmHg or 40mmHg) using computer generated random numbers sealed in an opaque envelope which is opened by the attending nurse or healthcare assistant who sets up the pressure of distension medium. The woman and the operator will be blinded to the allocated pressure. The hysteroscopy procedure will be performed by an experienced operator who will judge whether the uterine distension is adequate or inadequate. At this point the women will be asked to report her pain score between 0 to 10, using a Visual Analogue Scale. If the visualisation of the uterine cavity is inadequate, the operator will then ask the nurse/healthcare assistant to establish the pressure to 100 mmHg, which is the standard distension pressure used in the department to complete the procedure. Any additional necessary procedures such as biopsy, polyp or fibroid removal will be carried out after the assessment of the operator and the woman.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Adequate visualisation of the uterine cavity assessed at the same point when the operator judges whether the visualisation is adequate or inadequate

Secondary outcome measures

Visual Analogue Score (VAS) pain score assessed at the same point when the operator judges whether the visualisation is adequate or inadequate

Overall trial start date

01/03/2007

Overall trial end date

31/03/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women who are referred for an outpatient hysteroscopy procedure at the Univesity College London Hospitals
2. Those who give informed consent to participate in the trial

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

230 women

Participant exclusion criteria

1. Women who are unable to communicate in English
2. Those whoe are not suitable for an outpatient hysteroscopy (i.e active pelvic infection, possibility of pregnancy, unusually anxious women)

Recruitment start date

01/03/2007

Recruitment end date

31/03/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Women's Health Division
London
NW1 2PG
United Kingdom

Sponsor information

Organisation

University College London Hospitals NHS Foundation Trust (UK)

Sponsor details

250 Euston Road
London
NW1 2PG
United Kingdom
+44 (0)20 3456 7890
ertan.saridogan@uclh.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.uclh.org/

Funders

Funder type

Hospital/treatment centre

Funder name

University College London Hospitals NHS Foundation 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

2014 results in http://www.ncbi.nlm.nih.gov/pubmed/24262433

Publication citations

Additional files

Editorial Notes

16/03/2016: Publication reference added.