A New Alternative to Traditional Hysteroscopy

Not Applicable

Completed

• Conditions: Intrauterine Diseases; Myomas; Polyps
• Interventions: Procedure: resectoscopy

• Registration Number: NCT01430208
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

Hysteroscopy is a procedure designed for the diagnosis and the treatment of intra-uterine diseases. The development of smaller hysteroscopes allowed to change the approach to the intra-uterine lesions unifying the diagnostic and operative time. Recently Gubbini et al. developed a mini-resectoscope feasible for "see\&treat" hysteroscopy. The objective of the study is to compare the new 16 Fr mini28 resectoscope by Gubbini with Traditional 22 Fr resectoscope and Bettocchi 15 Fr hysteroscope for the treatment of uterine cavitary lesions. The investigators enrolled 401 women affected by endometrial polyps and/or G0 myomas, randomly allocated to receive the treatment with traditional resectoscope (127 women), with mini-resectoscope by Gubbini (142 women) and Bettocchi hysteroscope (132 women). Operating time, distension media delivered, dismiss time and discomfort experienced were recorded.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2011-04
• Study Completion: 2011-06
• Status Verified: 2011-09
• Study First Submitted: 2011-09-02
• Study First Submitted QC: 2011-09-07
• Last Update Submitted: 2011-09-07
• Study First Posted: 2011-09-08
• Last Update Posted: 2011-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 401

Inclusion Criteria

• women between 18-75 years of age
• endometrial polyps and/or G0 myomas smaller than 3 cm of diameter

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mini-resectoscope	resectoscopy	-
tradiorional resectoscope	resectoscopy	-
bettocchi resectoscope	resectoscopy	-

Primary Outcome Measures

Name	Time	Method
efficacy of the treatment with mini-resectoscope in comparison with the traditional hysteroscopy in the whole group of 401 patients	sixteen months	Operating time (min), distension media used (ml), dismiss time (hours), patients discomfort (VAS)

Secondary Outcome Measures

Name	Time	Method
efficacy of the treatment with mini-resectoscope in comparison with the traditional hysteroscopy in the treatment of intrauterine lesions larger than 1,5cm in diameter	sixteen months	Operating time(min), distension media used (ml), dismiss time (hours), patients discomfort (VAS)

Trial Locations

Locations (1)

Catholic university of Sacred Heart; 🇮🇹 Rome, Italy