Plain English Summary
Background and study aims
Saline infusion sonohysterography is an accurate ultrasound procedure that allows health care professionals to look at the inside of the uterus (endometrial cavity) and the uterus lining (endometrium). They are used for a number of reasons, including looking for polyps, investigating the reasons for postmenopausal (after the menopause) bleeding and looking at the shape of the endometrial cavity (this can be useful in investigating problems such as multiple miscarriages or infertility). It is a simple procedure often done in outpatient clinics, but it can be uncomfortable due to leaking of the saline during the test. Gel is now often used instead, as it is thought that using a gel (gel infusion sonohysterography) is less painful than saline and that it produces clearer images and allows for 3D sonography (for example, 3D ultrasound). A number of gels are available, some containing pure hydroxyethyl glycerin, others containing small amount of chlorhexidine with or without lidocaine. This may be important, as different gels may affect how painful the procedure is, cause different side effects and affect the quality of the image made, but there is, as yet, no published data on this. We suggest that a sonohysterography using gel that contains small amounts of chlorhexidine will be more painful than if a gel containing pure hydroxyethyl glycerine is used, but the resulting images produced will be of equal quality. The main purpose of this study is to compare two types of gel, Endosgel (which contains chlorhexidine) and ExEmgel (containing hydroxyethylcellulose and glycerol)
Who can participate?
Women aged between 20-80 years, suffering from either abnormal bleeding from the uterus or infertility believed to be due to an abnormality of the uterus and planned for a gel infusion sonohysterography (GIS).
What does the study involve?
Patients are randomly allocated into one of two groups. One group has GIS using Endosgel and the other group ExEmgel. Patients report on any pain felt during the procedure and the quality of the images obtained compared. Patients are then called by telephone to talk again about any pain experienced 3 weeks and then 3 months after the GIS
What are the possible benefits and risks of participating?
Both gels are used routinely and, in general, are well-tolerated and safe. Some discomfort may be felt by patients during the procedure.
Where is the study run from?
The VU University Medical Center (Netherlands)
When is the study starting and how long is it expected to run for?
September 2012 to March 2014
Who is funding the study?
1. Dutch Ministry of Education, Culture and Science (Netherlands)
2. VU University Medical Center (Netherlands)
Who is the main contact?
Dr Judith Huirne
j.huirne@vumc.nl
Trial website
Contact information
Type
Scientific
Primary contact
Dr Judith Huirne
ORCID ID
Contact details
Boelelaan 1117
Amsterdam
1081HV
Netherlands
+31 (0) 204444444
j.huirne@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
34744
Study information
Scientific title
Gel instillation sonohysterography (GIS) using Endosgel versus ExEmgel, comparison of pain and image quality
Acronym
GISPAIN (Gel Insillation Sonography and PAIN scores)
Study hypothesis
The purpose of this study is to compare two types of gel, Endosgel and ExEmgel, during gel instillation sonohysterography with respect to patients pain perception and image quality. We hypothesize that gel including small amounts of chlorhexidine induces more pain compared to pure hydroxethyl glycerin gel.
Ethics approval
Medical Ethical Review Committee VU University Medical Center (Medisch Etische Toetsingscommissie Vrije Universiteit medisch centrum), 09/03/2012, ref. 2011/36
Study design
Single-centre randomised controlled trial, blinded for the patient and examiners of the saved 3D images with respect to used type of gel (double-blind)
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
https://dl.dropboxusercontent.com/u/53686439/PatientenbriefCPM8metVerzekeringsbijlage.pdf
Condition
Healthy participants with abnormal uterine bleeding or infertility and suspected for having a intrauterine abnormality
Intervention
Intervention group: The use of ExEmgel.
Control group: The use of Endosgel.
Both gels are used in daily practice (in the VU University Medical Center [VUmc]) during GIS.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
AUC of continuous registered pain score (continuous VAS) during gel installation and following sonography.
Secondary outcome measures
1. Pain score (AUC using continuous pain registration) of the entire procedure and of specific parts of the procedure
2. Subjective reported VAS score
3. Image quality
Various prognostic factors will be registered.
Overall trial start date
01/09/2012
Overall trial end date
01/03/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Woman with abnormal uterine bleeding or infertility and suspected for having an intrauterine abnormality
2. Age 20-80 yr
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
70
Participant exclusion criteria
1. Pregnancy or premenopausal women in the luteal phase without use of contraception
2. Pelvic Inflammatory Disease (PID)
3. Risk of malignancy
4. Contraindication for the use of NSAIDS
5. Known allergy for chlorhexidine
6. Inability to understand Dutch or English
Recruitment start date
01/09/2012
Recruitment end date
01/03/2014
Locations
Countries of recruitment
Netherlands
Trial participating centre
Boelelaan 1117
Amsterdam
1081HV
Netherlands
Sponsor information
Organisation
VU University Medical Center (Netherlands)
Sponsor details
c/o Prof. H.A.M. Brölmann
Boelelaan 1117
Amsterdam
1081HV
Netherlands
+31 (0) 204444444
h.brolmann@vumc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Dutch Ministry of Education, Culture and Science (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
VU University Medical Center (Netherlands)
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