Contact information
Type
Scientific
Primary contact
Dr F.W. Jansen
ORCID ID
Contact details
Leiden University Medical Center
Department of Gynaecology
Albinusdreef 2
Leiden
2300 RC
Netherlands
+31 (0)71 5262871
F.W.Jansen@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR554
Study information
Scientific title
Acronym
BETSI trial
Study hypothesis
The patient compliance of bettochi hysteroscopy is equal to the compliance of saline infusion sonography.
Ethics approval
Received from local medical ethics committee
Study design
Randomised open label active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Indication for examination of uterine cavity
Intervention
1. Saline infusion sonography
2. Office diagnostic hysteroscopy according to vaginoscopic technique
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
1. Parameters for patients compliance
2. Inconclusiveness of technique
Secondary outcome measures
1. Failure rate
2. Complication rate
Overall trial start date
01/01/2006
Overall trial end date
01/04/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients with an indication for examination of cavum uteri
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
100
Participant exclusion criteria
1. Former office diagnostic hysteroscopy or saline infusion sonography in the past
2. Contraindication of diagnostic hysteroscopy or saline infusion sonography
Recruitment start date
01/01/2006
Recruitment end date
01/04/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
Leiden University Medical Centre (LUMC) (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
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18715407
Publication citations
-
Results
van Dongen H, de Kroon CD, van den Tillaart SA, Louwé LA, Trimbos-Kemper GC, Jansen FW, A randomised comparison of vaginoscopic office hysteroscopy and saline infusion sonography: a patient compliance study., BJOG, 2008, 115, 10, 1232-1237, doi: 10.1111/j.1471-0528.2008.01858.x.