Condition category
Surgery
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
26/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (Netherlands)

Sponsor details

Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18715407

Publication citations

  1. 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.

Additional files

Editorial Notes