A New Alternative to Traditional Hysteroscopy

Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01430208
• Other study ID #: HUMREP-11-0778
• Status: Completed
• Phase: N/A
• First received: September 2, 2011
• Last updated: September 7, 2011
• Start date: January 2010
• Est. completion date: June 2011

Study information

• Verified date: September 2011
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Catholic University of Sacred Heart
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: June 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• women between 18-75 years of age

• endometrial polyps and/or G0 myomas smaller than 3 cm of diameter

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intrauterine Diseases
• Myomas
• Polyps

Intervention

Procedure:
• resectoscopy
hysteroscopy for myomas G0 and/or polyps

Locations

Country	Name	City	State
Italy	Catholic university of Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of the treatment with mini-resectoscope in comparison with the traditional hysteroscopy in the whole group of 401 patients	Operating time (min), distension media used (ml), dismiss time (hours), patients discomfort (VAS)	sixteen months	No
Secondary	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	Operating time(min), distension media used (ml), dismiss time (hours), patients discomfort (VAS)	sixteen months	No