Contact information
Type
Scientific
Primary contact
Dr F.W. Jansen
ORCID ID
Contact details
Leiden University Medical Centre
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
NTR249
Study information
Scientific title
Acronym
SHAVER trial
Study hypothesis
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
Ethics approval received from the local medical ethics committee
Study design
Multicentre, randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/01/2005
Overall trial end date
01/04/2006
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
60
Participant exclusion criteria
1. Non-pedunculated disorders (type II myomas)
2. Suspicion of malignancy
3. Contra-indication for hysteroscopic surgery
Recruitment start date
01/01/2005
Recruitment end date
01/04/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Centre
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
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Leiden University Medical Centre (LUMC) (The 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