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

NCT ID: NCT02823119

Last Updated: 2016-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-06-30

Brief Summary

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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

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Mini-hysteroscopy

A rigid 2.7-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 3.3 mm.

Group Type EXPERIMENTAL

Mini-hysteroscopy

Intervention Type DEVICE

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

A rigid 2.9-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 5 mm

Group Type ACTIVE_COMPARATOR

Conventional Office Hysteroscopy

Intervention Type DEVICE

. 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Nulliparous patients

Exclusion Criteria

* Parous patients, menopausal status, cervical pathology, and previous cervical surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Usama M Fouda

M.D, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Usama M Fouda, M.D, PhD

Role: STUDY_DIRECTOR

Cairo University

Locations

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Obstetrics and Gynecology Department,Cairo university

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Usama M Fouda, M.D, PhD

Role: CONTACT

References

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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.

Reference Type BACKGROUND
PMID: 15730173 (View on PubMed)

Other Identifiers

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Hysteroscope size & pain

Identifier Type: -

Identifier Source: org_study_id

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