Comparison Between Different Filling Pressures in Diagnostic Outpatient Hysteroscopy

Cairo University (CU)

Status: Completed

Conditions: Hysteroscopy

Treatments: Device: Filling pressure 50; Device: Filling pressure 80; Device: Filling pressure 30

Study type: Interventional

Funder types: Other

Identifiers

NCT02142686

Hyst 1

Details and patient eligibility

About

The aim of this study is to compare different filling pressures

Full 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.

Enrollment: 240 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-60 years
• Has a clear Indication to have an outpatient hysteroscopy
• Consent to participate in the study

Exclusion criteria

• Premenstrual and midmenstrual patients.
• Patients with missed periods.
• Patients with known cardiac disease.
• Patients who need operative hysteroscopy

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 3 patient groups

Filling pressure 80

Active Comparator group

Description:

After the hysteroscope is introduced into the uterine cavity, the filling pressure will remain at 80mm.

Treatment:

Device: Filling pressure 80

Filling pressure 50.

Active Comparator group

Description:

After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 50mm Hg in this group

Treatment:

Device: Filling pressure 50

illing pressure 30

Active Comparator group

Description:

After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 30mm Hg.

Treatment:

Device: Filling pressure 30