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Uterine Filling Pressure in Hysteroscopy

Primary Purpose

Fibroids

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MyoSure Hysteroscopic Morcellator Device
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fibroids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Comprehensive GynecologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

60 mmHg MyoSure Hysteroscopic Morcellator Device

80 mmHg MyoSure Hysteroscopic Morcellator Device

Arm Description

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.

This is the standard of care pressurization for this procedure at Northwestern Medicine and will be the control group for the study

Outcomes

Primary Outcome Measures

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.
Procedure Time
Duration of surgery to assess if pressure changes affects length of surgery time.
Specimen Weight
Specimen will be sent to pathology to note weight in grams.
Amount of Fluid
Volume of normal saline used during procedure.
Lasix administered post-operatively
Noting yes or no if Lasix was administered post-operatively.
Change in pressure was needed
Noting if pressure needed changing by surgeon during the procedure.

Secondary Outcome Measures

Full Information

First Posted
August 28, 2020
Last Updated
February 16, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT04550429
Brief Title
Uterine Filling Pressure in Hysteroscopy
Official Title
The Effect of Decreased Uterine Filling Pressure in Hysteroscopy, a Double-blind Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibroids

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
60 mmHg MyoSure Hysteroscopic Morcellator Device
Arm Type
Active Comparator
Arm Description
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.
Arm Title
80 mmHg MyoSure Hysteroscopic Morcellator Device
Arm Type
Sham Comparator
Arm Description
This is the standard of care pressurization for this procedure at Northwestern Medicine and will be the control group for the study
Intervention Type
Device
Intervention Name(s)
MyoSure Hysteroscopic Morcellator Device
Intervention Description
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 Outcome Measure Information:
Title
Physician Survey to assess visualization
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Procedure Time
Description
Duration of surgery to assess if pressure changes affects length of surgery time.
Time Frame
Through study completion, an average of 1 year
Title
Specimen Weight
Description
Specimen will be sent to pathology to note weight in grams.
Time Frame
Through study completion, an average of 1 year
Title
Amount of Fluid
Description
Volume of normal saline used during procedure.
Time Frame
Through study completion, an average of 1 year
Title
Lasix administered post-operatively
Description
Noting yes or no if Lasix was administered post-operatively.
Time Frame
Through study completion, an average of 1 year
Title
Change in pressure was needed
Description
Noting if pressure needed changing by surgeon during the procedure.
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adaeze Emeka, MD
Phone
3128106830
Email
adaeze.emeka@nm.org
First Name & Middle Initial & Last Name or Official Title & Degree
cindy fuentes
Phone
312-926-0757
Email
cindy.fuentes@nm.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdy P Milad, MD, MM
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Comprehensive Gynecology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Carter, MHA
Phone
312-926-8525
Email
sarah.carter@nm.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.

Learn more about this trial

Uterine Filling Pressure in Hysteroscopy

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