Clinical Trial of Hysteroscopy in Postmenopausal Women to Compare Techniques
Nowadays,hysteroscopy is a golden standard procedure to describe the morphology of uterine cavity and investigate of abnormal uterine bleeding . The success of the procedure is based on the distension of the cavity . It can cause pain and discomfort and sometimes the procedure fails. . There are two techniques to make the procedure , one with gas and the other with saline solution. Objective: to compare two techniques concerning pain , procedure duration and image quality
|Study Design:||Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Phase 1 Study of Two Techniques in Hysteroscopy That Compare Carbon Dioxide Versus Saline Solution|
- Evaluation of the comfort in office hysteroscopy [ Time Frame: one year ] [ Designated as safety issue: No ]140 women will undergo office hysteroscopy to evaluate pain, time of the procedure and image quality using two techniques one with gas and the other with saline solution.
|Study Start Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Procedure: procedure hysteroscopy
The objective of this study is to compare two techniques in office hysteroscopy.In this clinical trial postmenopausal women will undergo a diagnostic hysteroscopy using carbon dioxide or saline solution to uterine cavity distension.
There will be two groups of 70 women each. The objective is to determine which technique provides better image,time of procedure and less discomfort.
|Departamento de Tocoginecologia FCM UNICAMP||Recruiting|
|Campinas, São Paulo, Brazil, 13083881|
|Contact: Valter Fausto Santos, graduade medicine 5516 33717814 ext 203 firstname.lastname@example.org|
|Contact: Ilza Maria Monteiro, Doctor degree 5516 97916241 email@example.com|
|Principal Investigator:||Valter Fausto Santos||University of Campinas, Brazil|