The objectives of this trial are:- To compare experienced pain during GIS using ExEmgel versus Endosgel (continuous measure pain and subjective reported VAS score)- To compare the image quality, including the occurrence of air bubbles during both…
ID
Source
Brief title
Condition
- Reproductive tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is AUC of continuous registered pain score (continuous VAS)
during gel installation and following sonography.
Secondary outcome
Other outcome parameters are pain score (AUC using continuous pain
registration) of the entire procedure and of specific parts of the procedure,
subjective reported VAS score and image quality. Various prognostic factors
will be registered.
Background summary
Sonohysterography using Saline or Gel has proven to be a very accurate
diagnostic method for the evaluation of intra-uterine disorders. Various gels
can be used during Gel installation Sonography (GIS). Some contain pure
hydroxyethyl glycerin, others contain small amount of chloorhexidine with or
without lidocaine. Although the gel content may effect pain perception, side
effects and imaging abilities, comparative studies have not been published yet.
We hypothesize that gel including small amounts of chloorhexidine induces more
pain compared to pure hydroxethyl glycerin gel.
The purpose of this study is, to compare two types of gel; Endosgel en ExEmgel
with respect to patients pain perception and image quality.
Study objective
The objectives of this trial are:
- To compare experienced pain during GIS using ExEmgel versus Endosgel
(continuous measure pain and subjective reported VAS score)
- To compare the image quality, including the occurrence of air bubbles during
both procedures (real time and retrospective during evaluation of the 3D
images).
Study design
The study will be a randomised controlled trial, blinded for the patient and
examiners of the saved 3D images with respect to used type of gel.
Intervention
Intervention group: The use of ExEmgel.
Control group: The use of Endosgel.
Both gels are used in daily practice (in the VUmc) during GIS.
Study burden and risks
Risks and burden are linked to the protocol procedures. Although these are
routine procedures, carried out by medically qualified personnel, they may
cause some discomfort and temporary pain to the subjects. However, these
procedures are general well-tolerated and save. The extra burden of
participation in the study is little and is limited till answering a couple of
questions with regard to history and complaints, to operate the continuous
painmeter during the whole procedure, and responding to three short
questionaries direct, 3 weeks and 3 months after the procedure. The total
burden in time is at maximum 15 minutes.
Albert Cuypstraat 219-2
1073 BG Amsterdam
NL
Albert Cuypstraat 219-2
1073 BG Amsterdam
NL
Listed location countries
Age
Inclusion criteria
- woman with abnormal uterine bleeding or infertility and suspected for having an intrauterine abnormality
- Age 20-80 yr
Exclusion criteria
- Pregnancy or premenopausal women in the luteal phase without use of contraception
- Pelvic Inflammatory Disease (PID)
- Risk of malignancy
- Contraindication for the use of NSAIDS
- Known allergy for chloorhexidine
- Inability to understand Dutch or English
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34744.029.11 |