Cairo University Hospitals
Cairo, Egypt
NCT Number: NCT02142686
The aim of this study is to compare different filling pressures
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Notify Me18 year–60 year
Female
Interventional
Not applicable
Cairo, Egypt
This study is a prospective double blinded randomised controlled trial. 240 women will be randomly divided into 3 groups, each containing 70 women. Randomisation will be performed using a computer generated random numbers and sealed envelopes.
Full history will be taken followed by general and local examination. The procedure will be done in the lithotomy position. Hysteroscopy will be done using a 5mm outer diameter continuous flow hysteroscope with a French working channel and a 30 degrees direction of view provided by Techno GmbH and CO. The hysteroscope will be introduced using the vaginoscopy technique, in which no speculum will be used. The cervix will be detected and the external os will be identified using the hysteroscope. The hysteroscope will be introduced in the uterine cavity. Saline will be used as the distension medium and the pressure will be set at 80mm Hg until the hysteroscope is introduced in the uterine cavity. After the hysteroscope is introduced into the uterine cavity, the filling pressure will remain at 80mm Hg in group1, will be reduced to 50mm Hg in group 2 and to 30mmHg in group 3. Randomisation will be double blind; neither the operator nor the patient will know the pressure during the procedure, a third party will set the pressure according to the computer generated random numbers.
The anterior wall, posterior wall and tubal ostea will be visualised, any polyps, adhesions septa, congenital malformations or submucous fibroids will be noted.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After the hysteroscope is introduced into the uterine cavity, the filling pressure will remain at 80mm Hg.
After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 50mm Hg.
After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 30mm
Time frame: 10 minutes after starting the procedure.
10 minutes after starting the procedure, the operator will document if adequate visualization was achieved using the allocated pressure. If visualization was not adequate, he will document that adequate visualization was not achieved using the allocated pressure and will ask for the pressure to be adjusted.
Time frame: 10 minutes after starting the procedure
Pain will be assessed by a visual analogue scale 10 minutes after starting the procedure.
Time frame: 30 minutes after starting the procedure.
Pain will be assessed by a visual analogue scale 30 minutes after starting the procedure.
Cairo University
Other
Comparison Between Different Filling Pressures in Diagnostic Outpatient Hysteroscopy: A Double Blinded Randomised Controlled Trial.
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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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