Gel instillation sonohysterography (GIS) using Endosgel versus ExEmgel, comparison of pain and image quality (Gel contrast echoscopie gebruikmakende van Endosgel versus ExEmgel, vergelijking van pijn en beeldkwaliteit)
| ISRCTN | ISRCTN84882393 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84882393 |
| Secondary identifying numbers | 34744 |
- Submission date
- 19/02/2014
- Registration date
- 14/07/2014
- Last edited
- 14/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
Boelelaan 1117
Amsterdam
1081HV
Netherlands
| Phone | +31 (0) 204444444 |
|---|---|
| j.huirne@vumc.nl |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | https://dl.dropboxusercontent.com/u/53686439/PatientenbriefCPM8metVerzekeringsbijlage.pdf |
| Scientific title | Gel instillation sonohysterography (GIS) using Endosgel versus ExEmgel, comparison of pain and image quality |
| Study acronym | GISPAIN (Gel Insillation Sonography and PAIN scores) |
| Study objectives | 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(s) | Medical Ethical Review Committee VU University Medical Center (Medisch Etische Toetsingscommissie Vrije Universiteit medisch centrum), 09/03/2012, ref. 2011/36 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2012 |
| Completion date | 01/03/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 70 |
| Key inclusion criteria | 1. Woman with abnormal uterine bleeding or infertility and suspected for having an intrauterine abnormality 2. Age 20-80 yr |
| Key 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 |
| Date of first enrolment | 01/09/2012 |
| Date of final enrolment | 01/03/2014 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
1081HV
Netherlands
Sponsor information
Hospital/treatment centre
c/o Prof. H.A.M. Brölmann
Boelelaan 1117
Amsterdam
1081HV
Netherlands
| Phone | +31 (0) 204444444 |
|---|---|
| h.brolmann@vumc.nl | |
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Government
No information available
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 |
