Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23840
Enrollment
60
Registered
2005-09-07
Start date
2005-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pedunculated and sessile intra-uterine disorders.

Interventions

1. Electrosurgical resection using the hystero-resectoscope (control)
2. Mechanical morcellating technique using the hysteroscopic morcellator (with saline irrigation).

Sponsors

Leiden University Medical Center, Leiden, The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Non pedunculated disorders (type II myomas); 2. Suspicion of malignancy; 3. Contra-indication for hysteroscopic surgery.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Complications (perforation, bleeding, TUR syndrom etc.), failure.

Contacts

Public ContactF.W. Jansen

Leiden University Medical Center (LUMC), Department of Gynaecology, P.O. Box 9600

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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)