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Intracranial Pressure in Monopolar and Bipolar Hysteroscopy

K

Kanuni Sultan Suleyman Training and Research Hospital

Status

Completed

Conditions

Intracranial Pressure Increase

Treatments

Procedure: Bipolar hysteroscopy
Procedure: Monopolar hysteroscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT04004923
Huseyin4

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

Female

Ages

18 to 49 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups

Monopolar hysteroscopy
Active Comparator group
Description:
This group of patients will receive Monopolar hysteroscopy for uterine distention.
Treatment:
Procedure: Monopolar hysteroscopy
Bipolar hysteroscopy
Active Comparator group
Description:
This group of patients will receive Monopolar hysteroscopy for uterine distention.
Treatment:
Procedure: Bipolar hysteroscopy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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