Condition category
Urological and Genital Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
19/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.lumc.nl/

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

Publication citations

Additional files

Editorial Notes