Comparison Between Two Different Distention Medium in Diagnostic Hysteroscopy

October 5, 2017 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

CO2 or Physiological Solution as Distension Medium: Which One is Better in Diagnostic Hysteroscopy?

The investigators aim to enroll 2000 patients to undergo diagnostic hysteroscopy for suspected uterine pathologies. Women will be randomized into two groups on the basis of distension medium : group A CO2; group B physiological solution. Pain discomfort will be evaluated after the examination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2000

Phase

  • Not Applicable

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • suspected uterine pathologies
  • infertility

Exclusion Criteria:

  • pregnancy
  • severe hypertension, cardiovascular disease or respiratory disease

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: carbon dioxide
Diagnostic hysteroscopy performed with the carbon dioxide (gas)
Procedure: diagnostic hysteroscopy
Endoscopic procedure to visualize uterine cavity
Drug: carbon dioxide
Active Comparator: physiological solution
Diagnostic hysteroscopy performed with liquid solution (physiologic solution)
Procedure: diagnostic hysteroscopy
Endoscopic procedure to visualize uterine cavity
Drug: physiological solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain discomfort during the procedure assessed through visual analogue scale (VAS)
Time Frame: up to six months
up to six months

Collaborators and Investigators

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

November 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

October 21, 2016

First Submitted That Met QC Criteria

November 7, 2016

First Posted (Estimate)

November 8, 2016

Study Record Updates

Last Update Posted (Actual)

October 6, 2017

Last Update Submitted That Met QC Criteria

October 5, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISC2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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