A New Alternative to Traditional Hysteroscopy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01430208

Enrollment

401

Registered

2011-09-08

Start date

2010-01-31

Completion date

2011-06-30

Last updated

2011-09-08

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

Conditions

Intrauterine Diseases, Myomas, Polyps

Keywords

endometrial pathology

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.

Interventions

PROCEDUREresectoscopy

hysteroscopy for myomas G0 and/or polyps

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026