Uterine Filling Pressure in Hysteroscopy

NCT ID: NCT04550429

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-21
• Study Completion Date: 2023-09-11

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.

Conditions

Fibroids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

MyoSure Hysteroscopic Morcellator Device

Intervention Type: 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.

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

Group Type: SHAM_COMPARATOR

MyoSure Hysteroscopic Morcellator Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Magdy Milad, MD

Professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Magdy P Milad, MD, MM

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Center for Comprehensive Gynecology

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STU00211845

Identifier Type: -

Identifier Source: org_study_id