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
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
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