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OpenTrials
Completed

NCT Number: NCT01430208

A New Alternative to Traditional Hysteroscopy

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.

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Key information

Conditions

Intrauterine Diseases Myoma Myomas Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Catholic university of Sacred Heart

Rome, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

resectoscopy

Procedure

hysteroscopy for myomas G0 and/or polyps

Primary outcomes

  1. efficacy of the treatment with mini-resectoscope in comparison with the traditional hysteroscopy in the whole group of 401 patients

    Time frame: sixteen months

    Operating time (min), distension media used (ml), dismiss time (hours), patients discomfort (VAS)

Secondary outcomes

  1. 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

    Time frame: sixteen months

    Operating time(min), distension media used (ml), dismiss time (hours), patients discomfort (VAS)

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 8, 2011
Registry last updated
Sep 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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