Office hysteroscopy compared to saline infusion sonohysterography: a randomised patient compliance study
| ISRCTN | ISRCTN05240400 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05240400 |
| Protocol serial number | NTR554 |
| Sponsor | Leiden University Medical Centre (LUMC) (Netherlands) |
| Funder | Leiden University Medical Centre (LUMC) (Netherlands) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised open label active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Parameters for patients compliance |
| Key secondary outcome measure(s) |
1. Failure rate |
| Completion date | 01/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
