|- candidate number||1430|
|- NTR Number||NTR249|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||7-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Hysteroscopic removal of intra-uterine disorders. A comparative study of learning electrosurgical- versus mechanical techniques.|
|- Scientific Title||Hysteroscopic removal of intra-uterine disorders. A comparative study of learning electrosurgical- versus mechanical techniques.|
|- ACRONYM||SHAVER trial|
|- Healt Condition(s) or Problem(s) studied||Intra-uterine disorders, Endometrial polyps, Submucous myomas |
|- 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).|
|- Exclusion criteria||1. Non pedunculated disorders (type II myomas);|
2. Suspicion of malignancy;
3. Contra-indication for hysteroscopic surgery.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2005|
|- planned closingdate||1-apr-2006|
|- Target number of participants||60|
|- Interventions||1. Electrosurgical resection using the hystero-resectoscope (control);|
2. Mechanical morcellating technique using the hysteroscopic morcellator (with saline irrigation).
|- Primary outcome||Parameters 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 outcome||Complications (perforation, bleeding, TUR syndrom etc.), failure.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Dr. F.W. Jansen|
|- CONTACT for SCIENTIFIC QUERIES||Dr. F.W. Jansen|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Leiden University Medical Center (LUMC)|
|- Brief summary||Objective:|
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.
Randomised clinical trial.
All patients with pedunculated and sessile intra-uterine disorders with an indication for removal.
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)|
|- RECORD||7-sep-2005 - 11-nov-2008|