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NCT02823119 Clinical Trial

Mini-hysteroscopy Versus Conventional Office Hysteroscopy in Nulliparous Patients Undergoing Office Hysteroscopy

Pain Clinical Trial

Official title:
Mini-hysteroscopy Versus Conventional Office Hysteroscopy in Nulliparous Patients Undergoing Diagnostic Office Hysteroscopy: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02823119
Other study ID # Hysteroscope size & pain
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received June 7, 2016
Last updated June 30, 2016
Start date August 2016
Est. completion date June 2017

Study information
Verified date June 2016
Source Cairo University
Contact Usama M Fouda, M.D, PhD
Email umfrfouda@yahoo.com
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effect of hysteroscope diameter on the pain experienced by nulliparous patients undergoing diagnostic office hysteroscopy.

Description:

The results of the studies comparing the pain experienced by the patients undergoing conventional office hysteroscopy or mini-hysteroscopy were mixed. Several studies revealed that mini-hysteroscopy significantly reduced the procedure related pain and other studies revealed that the use of mini-hysteroscope was not associated with significant reduction in the procedure related pain. The aim of this study is to evaluate the effect of hysteroscope diameter on the pain experienced by nulliparous patients undergoing diagnostic office hysteroscopy.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Nulliparous patients

Exclusion Criteria:

- Parous patients, menopausal status, cervical pathology, and previous cervical surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• Mini-hysteroscopy
Hysteroscopy will be performed with the use of the non-touch technique (vaginoscopic approach). The investigators will use a rigid 2.7-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 3.3 mm. All of the procedures will be diagnostic.
• Conventional Office Hysteroscopy
. Hysteroscopy will be performed with the use of the non-touch technique (vaginoscopic approach). The investigators will use a rigid 2.9-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 5 mm. All of the procedures will be diagnostic.

Locations
Country Name City State
Egypt Obstetrics and Gynecology Department,Cairo university Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Rullo S, Sorrenti G, Marziali M, Ermini B, Sesti F, Piccione E. Office hysteroscopy: comparison of 2.7- and 4-mm hysteroscopes for acceptability, feasibility and diagnostic accuracy. J Reprod Med. 2005 Jan;50(1):45-8. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Intensity of pain Intensity of pain assessed by the Visual Analog Scale (VAS)" up to 30 minutes No
Secondary Duration of procedure intraoperative No
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