Hysteroscopic removal of intra-uterine disorders: a comparative study of learning electrosurgical versus mechanical techniques

Completed

• Conditions: Pedunculated and sessile intra-uterine disorders; Urological and Genital Diseases; Inflammatory disease of uterus, except cervix

• Registration Number: ISRCTN46333673
• Lead Sponsor: eiden University Medical Centre (LUMC) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Parameters for easiness of use: <br>1. Operating-time<br>2. Amount of intravasation<br>3. Number of insertions of the instrument<br>4. Number of conversions to other techniques<br>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

Name	Time	Method
1. Complications (perforation, bleeding, transurethral resection (TUR) syndrome, etc.)<br>2. Failure