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Completed

NCT Number: NCT02142686

Comparison Between Different Filling Pressures in Diagnostic Outpatient Hysteroscopy

The aim of this study is to compare different filling pressures

Completed

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Hospitals

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Filling pressure 80

Device

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

Filling pressure 50

Device

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

Filling pressure 30

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 20, 2014
Registry last updated
Jan 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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