Condition category
Urological and Genital Diseases
Date applied
19/02/2014
Date assigned
14/07/2014
Last edited
14/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes