Office hysteroscopy compared to saline infusion sonohysterography: a randomised patient compliance study
| ISRCTN | ISRCTN05240400 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05240400 |
| Secondary identifying numbers | NTR554 |
- Submission date
- 14/02/2006
- Registration date
- 14/02/2006
- Last edited
- 26/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr F.W. Jansen
Scientific
Scientific
Leiden University Medical Center
Department of Gynaecology
Albinusdreef 2
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 5262871 |
|---|---|
| F.W.Jansen@lumc.nl |
Study information
| Study design | Randomised open label active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | |
| Study acronym | BETSI trial |
| Study objectives | The patient compliance of bettochi hysteroscopy is equal to the compliance of saline infusion sonography. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Indication for examination of uterine cavity |
| Intervention | 1. Saline infusion sonography 2. Office diagnostic hysteroscopy according to vaginoscopic technique |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Parameters for patients compliance 2. Inconclusiveness of technique |
| Secondary outcome measures | 1. Failure rate 2. Complication rate |
| Overall study start date | 01/01/2006 |
| Completion date | 01/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 100 |
| Key inclusion criteria | All patients with an indication for examination of cavum uteri |
| Key exclusion criteria | 1. Former office diagnostic hysteroscopy or saline infusion sonography in the past 2. Contraindication of diagnostic hysteroscopy or saline infusion sonography |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 01/04/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
"ROR" |
https://ror.org/027bh9e22 |
|---|
Funders
Funder type
Hospital/treatment centre
Leiden University Medical Centre (LUMC) (Netherlands)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2008 | Yes | No |
