N/A
ID
Bron
Verkorte titel
Aandoening
Pedunculated and sessile intra-uterine disorders.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Parameters for easiness of use: <br>
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).
Achtergrond van het onderzoek
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.
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.
Doel van het onderzoek
N/A
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
1. Electrosurgical resection using the hystero-resectoscope (control);
2. Mechanical morcellating technique using the hysteroscopic morcellator (with saline irrigation).
Publiek
Department of Gynaecology,
P.O. Box 9600
F.W. Jansen
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262871
F.W.Jansen@lumc.nl
Wetenschappelijk
Department of Gynaecology,
P.O. Box 9600
F.W. Jansen
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262871
F.W.Jansen@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
All patients with pedunculated and sessile intra-uterine disorders with an indication for removal (endometrial polyps and submucous myomas type 0 and I).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Non pedunculated disorders (type II myomas);
2. Suspicion of malignancy;
3. Contra-indication for hysteroscopic surgery.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL212 |
| NTR-old | NTR249 |
| Ander register | : N/A |
| ISRCTN | ISRCTN46333673 |