search
Back to results

Comparison Between Two Different Distention Medium in Diagnostic Hysteroscopy

Primary Purpose

Hysteroscopy, Distension Medium, Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
diagnostic hysteroscopy
physiological solution
carbon dioxide
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hysteroscopy, Distension Medium, Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • suspected uterine pathologies
  • infertility

Exclusion Criteria:

  • pregnancy
  • severe hypertension, cardiovascular disease or respiratory disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    carbon dioxide

    physiological solution

    Arm Description

    Diagnostic hysteroscopy performed with the carbon dioxide (gas)

    Diagnostic hysteroscopy performed with liquid solution (physiologic solution)

    Outcomes

    Primary Outcome Measures

    pain discomfort during the procedure assessed through visual analogue scale (VAS)

    Secondary Outcome Measures

    Full Information

    First Posted
    October 21, 2016
    Last Updated
    October 5, 2017
    Sponsor
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02958722
    Brief Title
    Comparison Between Two Different Distention Medium in Diagnostic Hysteroscopy
    Official Title
    CO2 or Physiological Solution as Distension Medium: Which One is Better in Diagnostic Hysteroscopy?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2016 (undefined)
    Primary Completion Date
    April 2017 (Actual)
    Study Completion Date
    April 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hysteroscopy, Distension Medium, Pain

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    2000 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    carbon dioxide
    Arm Type
    Active Comparator
    Arm Description
    Diagnostic hysteroscopy performed with the carbon dioxide (gas)
    Arm Title
    physiological solution
    Arm Type
    Active Comparator
    Arm Description
    Diagnostic hysteroscopy performed with liquid solution (physiologic solution)
    Intervention Type
    Procedure
    Intervention Name(s)
    diagnostic hysteroscopy
    Intervention Description
    Endoscopic procedure to visualize uterine cavity
    Intervention Type
    Drug
    Intervention Name(s)
    physiological solution
    Intervention Type
    Drug
    Intervention Name(s)
    carbon dioxide
    Primary Outcome Measure Information:
    Title
    pain discomfort during the procedure assessed through visual analogue scale (VAS)
    Time Frame
    up to six months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: suspected uterine pathologies infertility Exclusion Criteria: pregnancy severe hypertension, cardiovascular disease or respiratory disease

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Comparison Between Two Different Distention Medium in Diagnostic Hysteroscopy

    We'll reach out to this number within 24 hrs