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van CCT (UK)


Office hysteroscopy compared to saline infusion sonohysterography: a randomized patient compliance study.


- candidate number1907
- NTR NumberNTR554
- ISRCTNISRCTN5240400
- Date ISRCTN created14-feb-2006
- date ISRCTN requested13-jan-2006
- Date Registered NTR29-dec-2005
- Secondary IDsN/A 
- Public TitleOffice hysteroscopy compared to saline infusion sonohysterography: a randomized patient compliance study.
- Scientific TitleOffice hysteroscopy compared to saline infusion sonohysterography: a randomized patient compliance study.
- ACRONYMBETSI trial
- hypothesisThe patient compliance of bettochi hysteroscopy is equal to the compliance of saline infusion sonography.
- Healt Condition(s) or Problem(s) studiedUterine cavity
- Inclusion criteriaAll patients with an indication for examination of cavum uteri.
- Exclusion criteria1. Former office diagnostic hysteroscopy or saline infusion sonography in the past;
2. Contraindication of diagnostic hysteroscopy or saline infusion sonography.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2006
- planned closingdate1-apr-2007
- Target number of participants100
- Interventions1. Saline infusion sonography;
2. Office diagnostic hysteroscopy according vaginoscopic technique.
- Primary outcome1. Parameters for patients compliance;
2. Inconclusiveness of technique.
- Secondary outcome1. Failure rate;
2. Complication rate.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. F.W. Jansen
- CONTACT for SCIENTIFIC QUERIESDr. F.W. Jansen
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryObjective:
To compare saline infusion sonography with 'vaginoscopic' diagnostic hysteroscopy to assess patients compliance.

Patients:
All patients with an indication for examination of the cavum uteri.

Intervention:
Saline infusion sonography versus diagnostic hysteroscopy using the vaginoscopic technique.

Main outcome measures:
Parameters for patients compliance.
- Main changes (audit trail)
- RECORD29-dec-2005 - 27-nov-2009


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