NCT02142673

The Impact of Different Filling Pressures in Operative Outpatient Hysteroscopy on the Procedure Success Rates and Associated Pain.

The Impact of Different Filling Pressures in Operative Outpatient Hysteroscopy on the Procedure Success Rates and Associated Pain. A Randomized Double Blind 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 study aims to compare different filling pressures in operative outpatient hysteroscopy. Women will be divided into 3 groups. The hysteroscope will be introduced in the uterine cavity. Saline will be used as the distension medium and the pressure will be 80mm Hg in group1, 60mm Hg in group 2 and 40mmHg in group 3.

Detailed description

240 women will be randomly divided into 3 groups, each containing 80 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. One hour before the procedure all women will receive diclofenac 100mg (Voltaren@ Novartis Switzerland). 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 80mm Hg in group1, 60mm Hg in group 2 and 40 mmHg 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. If the procedure cannot be completed, the operator will ask for the pressure to be adjusted to 80mm Hg, which is the usual pressure used in Cairo university hospitals, or more if needed. In this case the operator will document in the data collection form that the procedure could not be completed with the pre-set pressure. The anterior wall, posterior wall and tubal ostea will be visualised, any polyps, adhesions septa, congenital malformations or submucous fibroids will be noted. Endometrial biopsy will be taken using a semi-rigid, double action oval serrated biopsy forceps 40cm 50Charr Tecchno medical GmbH. The used scissor will be a single action semi-rigid rounded tip scissors Tecchno medical GmbH.

Conditions

• Hysteroscopy

Interventions

Type	Name	Description
DEVICE	Filling pressure 80	The hysteroscope filling pressure will be 80mm Hg
DEVICE	Filling pressure 60	The hysteroscope filling pressure will be reduced to 50mm Hg
DEVICE	Filling pressure 40	The hysteroscope filling pressure will be 40mm Hg

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2014-05-20
• Last updated: 2016-08-03

Locations

1 site across 1 country: Egypt