NCT02142686

Comparison Between Different Filling Pressures in Diagnostic Outpatient Hysteroscopy

Comparison Between Different Filling Pressures in Diagnostic Outpatient Hysteroscopy: A Double Blinded Randomised Controlled Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare different filling pressures

Detailed description

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.

Conditions

• Hysteroscopy

Interventions

Type	Name	Description
DEVICE	Filling pressure 80	After the hysteroscope is introduced into the uterine cavity, the filling pressure will remain at 80mm Hg.
DEVICE	Filling pressure 50	After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 50mm Hg.
DEVICE	Filling pressure 30	After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 30mm

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2014-05-20
• Last updated: 2016-01-27

Locations

1 site across 1 country: Egypt