Optimum intrauterine filling pressures needed to perform outpatient diagnostic hysteroscopy

ISRCTN	ISRCTN78400671
DOI	https://doi.org/10.1186/ISRCTN78400671
Secondary identifying numbers	06/0112

Submission date: 02/12/2011
Registration date: 19/12/2011
Last edited: 16/03/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Mr Ertan Saridogan
Scientific

Women's Health Division
University College London Hospitals
250 Euston Road
London
NW1 2PG
United Kingdom

Phone	+44 20 3447 9759
Email	ertan.saridogan@uclh.nhs.uk

Study information

Study design	Double blind randomised trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information leaflet
Scientific title	Optimum intrauterine filling pressures needed to perform outpatient diagnostic hysteroscopy: a double-blind randomised trial
Study objectives	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(s)	The Joint UCL/UCLH Committes on the Ethics of Human Research, 28 September 2006, ref: 06/Q0502/69
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/03/2007
Completion date	31/03/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	230 women
Key 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
Key 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)
Date of first enrolment	01/03/2007
Date of final enrolment	31/03/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Women's Health Division

London
NW1 2PG
United Kingdom

Sponsor information

University College London Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

250 Euston Road
London
NW1 2PG
England
United Kingdom

Phone	+44 (0)20 3456 7890
Email	ertan.saridogan@uclh.nhs.uk
Website	http://www.uclh.org/
"ROR"	https://ror.org/042fqyp44

Funders

Funder type

Hospital/treatment centre

University College London Hospitals NHS Foundation Trust (UK)

No information available

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2014		Yes	No

Editorial Notes

16/03/2016: Publication reference added.