Hysteroscopic removal of intra-uterine disorders: a comparative study of learning electrosurgical versus mechanical techniques
| ISRCTN | ISRCTN46333673 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46333673 |
| Secondary identifying numbers | NTR249 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 19/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr F.W. Jansen
Scientific
Scientific
Leiden University Medical Centre
Department of Gynaecology
Albinusdreef 2
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 5262871 |
|---|---|
| F.W.Jansen@lumc.nl |
Study information
| Study design | Multicentre, randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | SHAVER trial |
| Study objectives | To compare the standard hysteroscopic electrosurgical resection technique with the new hysteroscopic morcellator technique in a residency program to assess the learning curve effect of both techniques. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Pedunculated and sessile intra-uterine disorders |
| Intervention | 1. Electrosurgical resection using the hystero-resectoscope (control) 2. Mechanical morcellating technique using the hysteroscopic morcellator (with saline irrigation) |
| Intervention type | Other |
| Primary outcome measure | Parameters for easiness of use: 1. Operating-time 2. Amount of intravasation 3. Number of insertions of the instrument 4. Number of conversions to other techniques 5. Completeness of removal and subjective score of the surgeon (resident in training) and supervisor-trainer by Visual Analogue Scales (range poor 0 and excellent 10) |
| Secondary outcome measures | 1. Complications (perforation, bleeding, transurethral resection (TUR) syndrome, etc.) 2. Failure |
| Overall study start date | 01/01/2005 |
| Completion date | 01/04/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 60 |
| Key inclusion criteria | All patients with pedunculated and sessile intra-uterine disorders with an indication for removal (endometrial polyps and submucous myomas type 0 and I) |
| Key exclusion criteria | 1. Non-pedunculated disorders (type II myomas) 2. Suspicion of malignancy 3. Contra-indication for hysteroscopic surgery |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 01/04/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Centre
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (Netherlands)
University/education
University/education
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Website | http://www.lumc.nl/ |
|---|---|
"ROR" |
https://ror.org/027bh9e22 |
Funders
Funder type
Hospital/treatment centre
Leiden University Medical Centre (LUMC) (The 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 |
