Fibroids
Conditions
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 the procedure. 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.
Interventions
DEVICEMyoSure Hysteroscopic Morcellator Device
This device is normally used for this procedure, but the investigators included it as an intervention because the pressure will be lowered for one arm of the study (treatment) and the pressure in the other arm will be remain unchanged (control) as the standard of care.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Investigator)
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)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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. Non-English speaking patients will be included in this study
Exclusion criteria
* Patients electing for operative and diagnostic hysteroscopy procedures with polyps and fibroids * Patients under the age of 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician Survey to Assess Visualization | Through study completion, an average of 1 year | 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. |
| Procedure Time | Through study completion, an average of 1 year | Duration of surgery to assess if pressure changes affects length of surgery time. |
| Specimen Weight | Through study completion, an average of 1 year | Specimen will be sent to pathology to note weight in grams. |
| Amount of Fluid | Through study completion, an average of 1 year | Volume of normal saline used during procedure. |
| Lasix Administered Post-operatively | Through study completion, an average of 1 year | Noting yes or no if Lasix was administered post-operatively. |
| Change in Pressure Was Needed | Through study completion, an average of 1 year | Noting if pressure needed changing by surgeon during the procedure. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMagdy P Milad, MD, MM
Northwestern University
Participant flow
Pre-assignment details
Thirty-five patients enrolled in the study by signing the informed consent form. 11 participants were assigned to the control group, and 8 participants to the experimental group.
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 8 |
| other Total, other adverse events | 0 / 11 | 0 / 8 |
| serious Total, serious adverse events | 0 / 11 | 0 / 8 |
Outcome results
None listed