NCT01430208

A New Alternative to Traditional Hysteroscopy

New Mini-resectoscope as Alternative to Traditional Hysteroscopy in the Treatment of Uterine Lesions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 401 (actual)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intrauterine Diseases
• Myomas
• Polyps

Interventions

Type	Name	Description
PROCEDURE	resectoscopy	hysteroscopy for myomas G0 and/or polyps

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-04-01
• Completion: 2011-06-01
• First posted: 2011-09-08
• Last updated: 2011-09-08

Locations

1 site across 1 country: Italy