Comparison Between Different Filling Pressures in Diagnostic Outpatient Hysteroscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-04-30

Brief Summary

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The aim of this study is to compare different filling pressures

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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.

Conditions

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Hysteroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Filling pressure 80

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

Group Type ACTIVE_COMPARATOR

Filling pressure 80

Intervention Type DEVICE

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

Filling pressure 50.

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

Group Type ACTIVE_COMPARATOR

Filling pressure 50

Intervention Type DEVICE

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

illing pressure 30

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

Group Type ACTIVE_COMPARATOR

Filling pressure 30

Intervention Type DEVICE

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

Interventions

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Filling pressure 80

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

Intervention Type DEVICE

Filling pressure 50

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

Intervention Type DEVICE

Filling pressure 30

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

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No