Hysteroscopic removal of intra-uterine disorders: a comparative study of learning electrosurgical versus mechanical techniques

ISRCTN	ISRCTN46333673
DOI	https://doi.org/10.1186/ISRCTN46333673
Protocol serial number	NTR249
Sponsor	Leiden University Medical Centre (LUMC) (Netherlands)
Funder	Leiden University Medical Centre (LUMC) (The Netherlands)

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

Dr F.W. Jansen
Scientific

Leiden University Medical Centre
Department of Gynaecology
Albinusdreef 2
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 5262871
Email	F.W.Jansen@lumc.nl

Primary study design	Interventional
Study design	Multicentre, randomised, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
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(s)	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)
Key secondary outcome measure(s)	1. Complications (perforation, bleeding, transurethral resection (TUR) syndrome, etc.) 2. Failure
Completion date	01/04/2006

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

Leiden University Medical Centre

Leiden
2300 RC
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan