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Data collection was not possible due to failure to maintain assigned uterine pressure from uncontrollable intraoperative fluctuations. Without stable pressure in either group, data would be invalid.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 60 mmHg MyoSure Hysteroscopic Morcellator Device | Active Comparator | The rationale for this experimental arm is that the pressurization can result in excess fluid being absorbed by the patient without a substantial benefit to surgical outcome. Minimizing the pressure from 80 mmHg (which is standard of care) to 60 mmHg used during this procedure may optimize outcome without compromising visualization of the surgeon. The research procedure will take place in the operating room of the minimally invasive gynecologic surgery department. |
|
| 80 mmHg MyoSure Hysteroscopic Morcellator Device | Sham Comparator | This is the standard of care pressurization for this procedure at Northwestern Medicine and will be the control group for the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyoSure Hysteroscopic Morcellator Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Procedure Time | Duration of surgery to assess if pressure changes affects length of surgery time. | Through study completion, an average of 1 year |
| Specimen Weight | Specimen will be sent to pathology to note weight in grams. | Through study completion, an average of 1 year |
| Amount of Fluid | Volume of normal saline used during procedure. | Through study completion, an average of 1 year |
| Lasix Administered Post-operatively | Noting yes or no if Lasix was administered post-operatively. | Through study completion, an average of 1 year |
| Change in Pressure Was Needed | Noting if pressure needed changing by surgeon during the procedure. | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magdy P Milad, MD, MM | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Comprehensive Gynecology | Chicago | Illinois | 60611 | United States |
Participant data will only involve consent forms, which will be stored in a locked cabinet in the research coordinators office along with the updated protocol and other study materials. The survey for the surgeon performing the procedure will be stored in the same place and used for data analysis.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 60 mmHg MyoSure Hysteroscopic Morcellator Device | The rationale for this experimental arm is that the pressurization can result in excess fluid being absorbed by the patient without a substantial benefit to surgical outcome. Minimizing the pressure from 80 mmHg (which is standard of care) to 60 mmHg used during this procedure may optimize outcome without compromising visualization of the surgeon. The research procedure will take place in the operating room of the minimally invasive gynecologic surgery department. 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. |
| FG001 | 80 mmHg MyoSure Hysteroscopic Morcellator Device | This is the standard of care pressurization for this procedure at Northwestern Medicine and will be the control group for the study 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No participants contributed data to the baseline measures.
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| ID | Title | Description |
|---|---|---|
| BG000 | 60 mmHg MyoSure Hysteroscopic Morcellator Device | The rationale for this experimental arm is that the pressurization can result in excess fluid being absorbed by the patient without a substantial benefit to surgical outcome. Minimizing the pressure from 80 mmHg (which is standard of care) to 60 mmHg used during this procedure may optimize outcome without compromising visualization of the surgeon. The research procedure will take place in the operating room of the minimally invasive gynecologic surgery department. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | No baseline or demographic data were collected for this outcome. Consistent exposure to assigned intrauterine pressures could not be achieved due to uncontrollable intraoperative fluctuations. Without stable pressure in either group, data would be invalid. As no participants received stable exposure and data collection was never initiated, no baseline characteristics were recorded in the study database. Therefore, no data are available to summarize or report. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | No data were collected for this outcome. Although participants were assigned to groups, 11 to the control group and 8 to the experimental group, target intrauterine pressures (60 or 80 mmHg) could not be consistently maintained due to frequent intraoperative adjustments. As a result, participants did not receive a stable exposure to the assigned pressure levels. Without stable exposure to the assigned conditions, data collection was not initiated, and no analyzable data are available to report. | Posted | Through study completion, an average of 1 year |
|
Adverse events were monitored through study completion, an average of 3 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 60 mmHg MyoSure Hysteroscopic Morcellator Device | The rationale for this experimental arm is that the pressurization can result in excess fluid being absorbed by the patient without a substantial benefit to surgical outcome. Minimizing the pressure from 80 mmHg (which is standard of care) to 60 mmHg used during this procedure may optimize outcome without compromising visualization of the surgeon. The research procedure will take place in the operating room of the minimally invasive gynecologic surgery department. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Magdy Milad | Northwestern Medicine | 3126946447 | mmilad@nm.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 21, 2022 | Oct 16, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 17, 2020 | Aug 31, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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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)
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| BG001 | 80 mmHg MyoSure Hysteroscopic Morcellator Device | This is the standard of care pressurization for this procedure at Northwestern Medicine and will be the control group for the study 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. |
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous | No baseline or demographic data were collected for this outcome. Consistent exposure to assigned intrauterine pressures could not be achieved due to uncontrollable intraoperative fluctuations. Without stable pressure in either group, data would be invalid. As no participants received stable exposure and data collection was never initiated, no baseline characteristics were recorded in the study database. Therefore, no data are available to summarize or report. | years |
| Sex: Female, Male | No baseline or demographic data were collected for this outcome. Consistent exposure to assigned intrauterine pressures could not be achieved due to uncontrollable intraoperative fluctuations. Without stable pressure in either group, data would be invalid. As no participants received stable exposure and data collection was never initiated, no baseline characteristics were recorded in the study database. Therefore, no data are available to summarize or report. |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
| Region of Enrollment | No baseline or demographic data were collected for this outcome. Consistent exposure to assigned intrauterine pressures could not be achieved due to uncontrollable intraoperative fluctuations. Without stable pressure in either group, data would be invalid. As no participants received stable exposure and data collection was never initiated, no baseline characteristics were recorded in the study database. Therefore, no data are available to summarize or report. | participants |
|
| OG001 | 80 mmHg MyoSure Hysteroscopic Morcellator Device | This is the standard of care pressurization for this procedure at Northwestern Medicine and will be the control group for the study 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. |
|
| Primary | Procedure Time | Duration of surgery to assess if pressure changes affects length of surgery time. | No data were collected for this outcome. Although participants were assigned to groups, 11 to the control group and 8 to the experimental group, target intrauterine pressures (60 or 80 mmHg) could not be consistently maintained due to frequent intraoperative adjustments. As a result, participants did not receive a stable exposure to the assigned pressure levels. Without stable exposure to the assigned conditions, data collection was not initiated, and no analyzable data are available to report. | Posted | Through study completion, an average of 1 year |
|
|
| Primary | Specimen Weight | Specimen will be sent to pathology to note weight in grams. | No data were collected for this outcome. Although participants were assigned to groups, 11 to the control group and 8 to the experimental group, target intrauterine pressures (60 or 80 mmHg) could not be consistently maintained due to frequent intraoperative adjustments. As a result, participants did not receive a stable exposure to the assigned pressure levels. Without stable exposure to the assigned conditions, data collection was not initiated, and no analyzable data are available to report. | Posted | Through study completion, an average of 1 year |
|
|
| Primary | Amount of Fluid | Volume of normal saline used during procedure. | No data were collected for this outcome. Although participants were assigned to groups, 11 to the control group and 8 to the experimental group, target intrauterine pressures (60 or 80 mmHg) could not be consistently maintained due to frequent intraoperative adjustments. As a result, participants did not receive a stable exposure to the assigned pressure levels. Without stable exposure to the assigned conditions, data collection was not initiated, and no analyzable data are available to report. | Posted | Through study completion, an average of 1 year |
|
|
| Primary | Lasix Administered Post-operatively | Noting yes or no if Lasix was administered post-operatively. | No data were collected for this outcome. Although participants were assigned to groups, 11 to the control group and 8 to the experimental group, target intrauterine pressures (60 or 80 mmHg) could not be consistently maintained due to frequent intraoperative adjustments. As a result, participants did not receive a stable exposure to the assigned pressure levels. Without stable exposure to the assigned conditions, data collection was not initiated, and no analyzable data are available to report. | Posted | Through study completion, an average of 1 year |
|
|
| Primary | Change in Pressure Was Needed | Noting if pressure needed changing by surgeon during the procedure. | No data were collected for this outcome. Although participants were assigned to groups, 11 to the control group and 8 to the experimental group, target intrauterine pressures (60 or 80 mmHg) could not be consistently maintained due to frequent intraoperative adjustments. As a result, participants did not receive a stable exposure to the assigned pressure levels. Without stable exposure to the assigned conditions, data collection was not initiated, and no analyzable data are available to report. | Posted | Through study completion, an average of 1 year |
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | 80 mmHg MyoSure Hysteroscopic Morcellator Device | This is the standard of care pressurization for this procedure at Northwestern Medicine and will be the control group for the study 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. | 0 | 8 | 0 | 8 | 0 | 8 |
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