Comparison Between Different Filling Pressures in Diagnostic Outpatient Hysteroscopy

Study Overview
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Brief Summary
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The aim of this study is to compare different filling pressures

Detailed Description
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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.

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

Conditions
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Hysteroscopy

Intervention / Treatment
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* Device: Filling pressure 80
* Device: Filling pressure 50
* Device: Filling pressure 30


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Filling pressure 80<br>After the hysteroscope is introduced into the uterine cavity, the filling pressure will remain at 80mm. | Device: Filling pressure 80<br>* After the hysteroscope is introduced into the uterine cavity, the filling pressure will remain at 80mm Hg.<br>|
| Active Comparator: Filling pressure 50.<br>After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 50mm Hg in this group | Device: Filling pressure 50<br>* After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 50mm Hg.<br>|
| Active Comparator: illing pressure 30<br>After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 30mm Hg. | Device: Filling pressure 30<br>* After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 30mm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adequate visualization of the uterine cavity | 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. | 10 minutes after starting the procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain perceived by the patient | Pain will be assessed by a visual analogue scale 10 minutes after starting the procedure. | 10 minutes after starting the procedure | 
| Pain perceived by the patient 30 minutes after starting the procedure. | Pain will be assessed by a visual analogue scale 30 minutes after starting the procedure. | 30 minutes after starting the procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hysteroscopy, Filling pressures