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Hysteroscopic removal of intra-uterine disorders. A comparative study of learning electrosurgical- versus mechanical techniques.


- candidate number1430
- NTR NumberNTR249
- ISRCTNISRCTN46333673
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR7-sep-2005
- Secondary IDsN/A 
- Public TitleHysteroscopic removal of intra-uterine disorders. A comparative study of learning electrosurgical- versus mechanical techniques.
- Scientific TitleHysteroscopic removal of intra-uterine disorders. A comparative study of learning electrosurgical- versus mechanical techniques.
- ACRONYMSHAVER trial
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedIntra-uterine disorders, Endometrial polyps, Submucous myomas
- Inclusion criteriaAll patients with pedunculated and sessile intra-uterine disorders with an indication for removal (endometrial polyps and submucous myomas type 0 and I).
- Exclusion criteria1. Non pedunculated disorders (type II myomas);
2. Suspicion of malignancy;
3. Contra-indication for hysteroscopic surgery.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2005
- planned closingdate1-apr-2006
- Target number of participants60
- Interventions1. Electrosurgical resection using the hystero-resectoscope (control);
2. Mechanical morcellating technique using the hysteroscopic morcellator (with saline irrigation).
- Primary outcomeParameters for easiness of use:
operating-time, amount of intravasation, number of insertions of the instrument, number of conversions to other techniques, 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 outcomeComplications (perforation, bleeding, TUR syndrom etc.), failure.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. F.W. Jansen
- CONTACT for SCIENTIFIC QUERIESDr. F.W. Jansen
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryObjective:
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.


Design:
Randomised clinical trial.


Patients:
All patients with pedunculated and sessile intra-uterine disorders with an indication for removal.


Intervention:
Electrosurgical resection using the hystero-resectoscope versus mechanical morcellating technique using hysteroscopic morcellator.


Main outcome measures:
Parameters for easiness of use.
- Main changes (audit trail)
- RECORD7-sep-2005 - 11-nov-2008


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