Comparison Between Two Different Distention Medium in Diagnostic Hysteroscopy

Not Applicable

Completed

• Conditions: Hysteroscopy, Distension Medium, Pain
• Interventions: Procedure: diagnostic hysteroscopy; Drug: carbon dioxide; Drug: physiological solution

• Registration Number: NCT02958722
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-21
• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted QC: 2016-11-07
• Study First Posted: 2016-11-08
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Last Update Submitted: 2017-10-05
• Last Update Posted: 2017-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

• suspected uterine pathologies
• infertility

Exclusion Criteria

• pregnancy
• severe hypertension, cardiovascular disease or respiratory disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
carbon dioxide	diagnostic hysteroscopy	Diagnostic hysteroscopy performed with the carbon dioxide (gas)
carbon dioxide	carbon dioxide	Diagnostic hysteroscopy performed with the carbon dioxide (gas)
physiological solution	diagnostic hysteroscopy	Diagnostic hysteroscopy performed with liquid solution (physiologic solution)
physiological solution	physiological solution	Diagnostic hysteroscopy performed with liquid solution (physiologic solution)

Primary Outcome Measures

Name	Time	Method
pain discomfort during the procedure assessed through visual analogue scale (VAS)	up to six months