Comparison Between Different Filling Pressures in Diagnostic Outpatient Hysteroscopy

January 26, 2016 updated by: AbdelGany Hassan, Cairo University

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

The aim of this study is to compare different filling pressures

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Filling pressure 80
After the hysteroscope is introduced into the uterine cavity, the filling pressure will remain at 80mm.
Device: Filling pressure 80
After the hysteroscope is introduced into the uterine cavity, the filling pressure will remain at 80mm Hg.
Active Comparator: Filling pressure 50.
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
After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 50mm Hg.
Active Comparator: illing pressure 30
After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 30mm Hg.
Device: Filling pressure 30
After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 30mm

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: AbdelGany M A Hassan, MRCOG, MD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

May 16, 2014

First Submitted That Met QC Criteria

May 16, 2014

First Posted (Estimate)

May 20, 2014

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Hyst 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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