A New Alternative to Traditional Hysteroscopy

Catholic University of the Sacred Heart

Status: Completed

Conditions: Polyps; Intrauterine Diseases; Myomas

Treatments: Procedure: resectoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01430208

HUMREP-11-0778

Details and patient eligibility

About

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.

Enrollment: 401 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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401 participants in 3 patient groups

mini-resectoscope

Active Comparator group

Treatment:

Procedure: resectoscopy

tradiorional resectoscope

Active Comparator group

Treatment:

Procedure: resectoscopy

bettocchi resectoscope

Active Comparator group

Treatment:

Procedure: resectoscopy