Uterine Filling Pressure in Hysteroscopy

Fibroids Clinical Trial

Official title:

The Effect of Decreased Uterine Filling Pressure in Hysteroscopy, a Double-blind Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04550429
• Other study ID #: STU00211845
• Status: Completed
• Phase: N/A
• Start date: August 21, 2020
• Est. completion date: September 11, 2023

Study information

• Verified date: February 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to compare the outcomes of patients undergoing hysteroscopy with a Myosure device with a pressure of 60 mmHg to those using the standard of 80 mmHg.

Description:

An a priori sample size calculation was completed. To achieve 80% power and an alpha of .05, the study team needed a sample size of 68 total with 34 participants in each group.The study will be a double-blind randomized control trial. Patients will be recruited based on surgery type (hysteroscopy) and consented using a written consent by the research coordinator with sufficient time to ensure patient comprehension and allow for any questions. The consent process will happen in the pre-operative appointment. Participants will then be randomized to either the standard of care of 80mmHg or the experimental pressure of 60 mmHg for uterine filling pressure via an automated randomization program. The physician performing the surgery and the patient will not know what group they are assigned to. The procedure involved in the study will be hysteroscopy. Hysteroscopy is a procedure that is used to diagnose and sometimes treat intrauterine pathologies. In order to visualize the uterus, pressurized saline is used to distend the uterus.

In this study, the specific hysteroscopic procedure will involve the removal of uterine fibroids with a MyoSure Hysteroscopic Morcellator device. These tissue samples will be collected and sent to Pathology to be weighed. During the surgery, the surgeon will be able to request an adjustment pressure if visualization is not adequate. Physicians will start with a pressure of 80mmHg. Once physician is ready to introduce the myosure hysteroscopy device, the pressure level will then be randomized. During the procedure, monitoring will be done by anesthesia through the use of pulse oximetry and measurement of vitals during the Monitored Anesthesia Care. There is also real-time monitoring of hysteroscopic fluid deficit via the fluid management system that is attached to the hysteroscopic pump. Fluid deficit can also be confirmed by the nurse who manually counts the amount of fluid used during theprocedure. Per policy, once a 2500mL deficit is reached, the procedure is terminated. After the surgery, the surgeon will fill out a questionnaire that measures the outcomes of surgeon satisfaction and visualization during the procedure. The other end points of procedure time, specimen weight, volume of normal saline used, any changes in pressure needed during the surgery, and whether the patient required Lasix post-operatively will also be collected at this time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 11, 2023
• Est. primary completion date: September 11, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients electing for operative or diagnostic hysteroscopy procedures for management of polyps and fibroids

• Age equal to or greater than 18

• Ability to understand and willingness to sign consent form. We will include non-English speaking patients in this study

Exclusion Criteria:

• Patients electing for operative and diagnostic hysteroscopy procedures with polyps and fibroids

• Patients under the age of 18

Related Conditions & MeSH terms

• Fibroids
• Leiomyoma

Intervention

Device:
• MyoSure Hysteroscopic Morcellator Device
This device is normally used for this procedure, but I included it as intervention because we will lower the pressure for one arm of the study (treatment) and keep the pressure in the other arm (control) as the standard of care.

Locations

Country	Name	City	State
United States	Center for Comprehensive Gynecology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician Survey to assess visualization	Determining whether lowering pressure on hysteroscopic morcellator during hysteroscopy, using block randomization, affects visualization for surgeon using a post-op survey for surgeon to gauge outcomes.	Through study completion, an average of 1 year
Primary	Procedure Time	Duration of surgery to assess if pressure changes affects length of surgery time.	Through study completion, an average of 1 year
Primary	Specimen Weight	Specimen will be sent to pathology to note weight in grams.	Through study completion, an average of 1 year
Primary	Amount of Fluid	Volume of normal saline used during procedure.	Through study completion, an average of 1 year
Primary	Lasix administered post-operatively	Noting yes or no if Lasix was administered post-operatively.	Through study completion, an average of 1 year
Primary	Change in pressure was needed	Noting if pressure needed changing by surgeon during the procedure.	Through study completion, an average of 1 year