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

Phase 2

• Conditions: Pain
• Interventions: Device: Mini-hysteroscopy; Device: Conventional Office Hysteroscopy

• Registration Number: NCT02823119
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2016-06
• Study First Submitted: 2016-06-07
• Study First Submitted QC: 2016-06-30
• Last Update Submitted: 2016-06-30
• Study First Posted: 2016-07-06
• Last Update Posted: 2016-07-06
• Study Start: 2016-08
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Nulliparous patients

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mini-hysteroscopy	Mini-hysteroscopy	A rigid 2.7-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 3.3 mm.
Conventional Office Hysteroscopy	Conventional Office Hysteroscopy	A rigid 2.9-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 5 mm

Primary Outcome Measures

Name	Time	Method
Intensity of pain	up to 30 minutes	Intensity of pain assessed by the Visual Analog Scale (VAS)"

Secondary Outcome Measures

Name	Time	Method
Duration of procedure	intraoperative

Trial Locations

Locations (1)

Obstetrics and Gynecology Department,Cairo university; 🇪🇬 Cairo, Egypt