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Intracranial Pressure in Monopolar and Bipolar Hysteroscopy

Monopolar or Bipolar Hysteroscopy: Comparison of the Impact of Two Methods on Intracranial Pressure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04004923
Enrollment
80
Registered
2019-07-02
Start date
2019-07-05
Completion date
2019-10-30
Last updated
2020-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Pressure Increase

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.

Detailed description

Operative hysteroscopy is currently used in the treatment of several diseases including submucosal myomas, polyps, uterine septum, and abnormal intrauterine bleeding. Two different methods for distension of the uterus for hysteroscopy are available currently. One is monopolar and the second is bipolar. The monopolar fluid contains mannitol and the bipolar fluid contains serum physiologic. Passage of the distention fluid into the uterine veins during hysteroscopy might lead to volume overload, water intoxication, hyponatremia, pulmonary edema or brain edema. However, the effect of monopolar hysteroscopy or bipolar hysteroscopy on intracranial pressure in patients undergoing hysteroscopy is unknown. Optic nerve sheath diameter (ONSD) measurement is a surrogate marker of invasive intracranial pressure. This study aims to compare the impact of monopolar and bipolar hysteroscopy on intracranial pressure by using ONSD measurement in patients undergoing hysteroscopy.

Interventions

PROCEDUREMonopolar hysteroscopy

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

PROCEDUREBipolar hysteroscopy

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

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Postmenopause; * Kidney disease; * Cardiovascular disease; * Glaucoma

Design outcomes

Primary

MeasureTime frameDescription
Intracranial pressureONSD will be measured 3 times in the two groups. Before completion of hysteroscopy, 2 hours after hysteroscopy and 6 hours after hysteroscopyThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026