NCT04004923

Brief Summary

Two distinction fluids are used in operative hysteroscopy. One is monopolar and the second is bipolar. The monopolar fluid contains mannitol and the bipolar fluid contains serum physiologic. This study aims to compare intracranial pressure in patients undergoing monopolar and bipolar hysteroscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

July 5, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

4 months

First QC Date

June 30, 2019

Last Update Submit

February 19, 2020

Conditions

Intracranial Pressure Increase

Outcome Measures

Primary Outcomes (1)

  • Intracranial pressure

    The difference in intracranial pressure between the two study arms measured with optic nerve sheath diameter (ONSD). ONSD is measured using a linear ultrasound probe and reflects intracranial pressure.

    ONSD will be measured 3 times in the two groups. Before completion of hysteroscopy, 2 hours after hysteroscopy and 6 hours after hysteroscopy

Study Arms (2)

Monopolar hysteroscopy

ACTIVE COMPARATOR

This group of patients will receive Monopolar hysteroscopy for uterine distention.

Procedure: Monopolar hysteroscopy

Bipolar hysteroscopy

ACTIVE COMPARATOR

This group of patients will receive Monopolar hysteroscopy for uterine distention.

Procedure: Bipolar hysteroscopy

Interventions

Monopolar hysteroscopyPROCEDURE

Unipolar resectoscopes are used in this group and the distention fluid is mannitol

Monopolar hysteroscopy
Bipolar hysteroscopyPROCEDURE

Bipolar resectoscopes are used in this group and the distention fluid is serum physiologic

Bipolar hysteroscopy

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Must be scheduled to hysteroscopy for treatment of uterine myoma, polyp, septum, or for endometrial ablation.

You may not qualify if:

  • Postmenopause;
  • Kidney disease;
  • Cardiovascular disease;
  • Glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Please Enter the State Or Province, 34005, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Huseyin Kiyak, MD

    Kanuni Sultan Suleyman Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, M.D.

Study Record Dates

First Submitted

June 30, 2019

First Posted

July 2, 2019

Study Start

July 5, 2019

Primary Completion

October 25, 2019

Study Completion

October 30, 2019

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)