Clinical trial NCT04550429: Uterine Filling Pressure in Hysteroscopy
Official title: The Effect of Decreased Uterine Filling Pressure in Hysteroscopy, a Double-blind Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibroids
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Using block randomization to divide patients into two groups using two different levels of pressure on the hysteroscopic morcellator: experimental group (those receiving 60 mmHg of pressure) and control group (those receiving 80 mmHg of pressure)
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Physician Survey to assess visualization
timeFrame: Through study completion, an average of 1 year
measure: Procedure Time
timeFrame: Through study completion, an average of 1 year
measure: Specimen Weight
timeFrame: Through study completion, an average of 1 year
measure: Amount of Fluid
timeFrame: Through study completion, an average of 1 year
measure: Lasix administered post-operatively
timeFrame: Through study completion, an average of 1 year
measure: Change in pressure was needed
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Center for Comprehensive Gynecology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Magdy P Milad, MD, MM
role: PRINCIPAL_INVESTIGATOR
References: