Condition category
Surgery
Date applied
22/06/2015
Date assigned
24/07/2015
Last edited
24/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A hysteroscopy is a procedure used to examine the inside of the uterus. It is an established diagnostic tool. One of the main causes of procedure failure is patient discomfort and pain. We do not know what the best way of reducing pain is. The aim of this study is to compare a warm normal saline distension solution versus a standard room-temperature normal saline.

Who can participate?
Women referred for outpatient hysteroscopy between January 2013 and June 2015.

What does the study involve?
Participants are allocated to one of two groups: one group receiving a sterile 0.9% normal saline warmed up to 32 degrees C as distention medium or another group receiving a room temperature sterile 0.9% normal saline solution. No pre medication or anaesthetics procedure used.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Central Clinical Hospital of Ministry of the Interior in Warsaw (CSK MSW) Department Obstetrics and Gynaecology (Poland)

When is the study starting and how long is it expected to run for?
January 2015 to July 2015

Who is funding the study?
Central Clinical Hospital of Ministry of the Interior in Warsaw (CSK MSW) Department Obstetrics and Gynaecology (Poland)

Who is the main contact?
Tadeusz Issat

Trial website

Contact information

Type

Scientific

Primary contact

Mr Tadeusz Issat

ORCID ID

Contact details

CSK MSW
Woloska 137
Warsaw
02-507
Poland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A prospective randomized study for pain assessment during outpatient hysteroscopy using room temperature versus warm normal saline as distention medium.

Acronym

Study hypothesis

To assess the efficacy of warm normal saline distension solution versus a standard, room-temperature normal saline as distension medium for the pain relief during outpatient hysteroscopy.

Ethics approval

Ethics Board and Control of Research trials on Humans and Animals in CSK MSW Warsaw, 01/07/2012, ref 73/2012

Study design

Prospective randomized single center trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Outpatient hysteroscopy

Intervention

Office hysteroscopy with warm normal saline distension solution or a standard room temperature normal saline distension medium

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Visual analogue scale (VAS) score during, 5 minutes and 15 minutes after the procedure. Median VAS scores during and directly after the anaesthesia-free hysteroscopy.

Secondary outcome measures

Side effects, complications failure rate, procedure time and the pain level during each stage of procedure.

Overall trial start date

01/01/2014

Overall trial end date

31/07/2015

Reason abandoned

Eligibility

Participant inclusion criteria

All patients aged over 18 years referred for hysteroscopy for diagnosis of abnormal endometrium on ultrasound, endometrial polyps and uterine bleeding were included in the study. All participants had a pelvic ultrasound examination to confirm the initial diagnosis.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

100

Participant exclusion criteria

Women with a possible pregnancy, lower genital tract infections, gestational trophoblastic disease, presence of endocervical polyps visualized on a speculum examination, asthma, acute porphyria, hepatitis, renal failure, lactation and oversensitivity to one of the agents or their elements were excluded.
Patients with endometrial polyps measuring more than 30mm were excluded and referred for operative hysteroscopy under anesthesia.

Recruitment start date

01/01/2015

Recruitment end date

20/06/2015

Locations

Countries of recruitment

Poland

Trial participating centre

Central Clinical Hospital of Ministry of the Interior in Warsaw (CSK MSW) Department Obs and Gyn
Warsaw
02-507
Poland

Sponsor information

Organisation

Central Clinical Hospital of Ministry of the Interior in Warsaw (CSK MSW) Department Obs and Gyn

Sponsor details

Department of Obstetrics and Gynaecology
Woloska 137
Warsaw
02/507
Poland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Central Clinical Hospital of Ministry of the Interior in Warsaw (CSK MSW) Department Obs and Gyn

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication in peer reviewed journal focused on minimally invasive gynaecology. Publication of the results and conclusion after finalizing the analysis in around 2 months.

Intention to publish date

31/12/2015

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes