Green Hysteroscopy

NCT ID: NCT06379841

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-19
• Study Completion Date: 2025-06-14

Brief Summary

The purpose of this study is to determine whether green draping in the operating room prior to a hysteroscopy results in a decreased operating room time.

Secondary aims are to determine whether there are any differences in infection rate, complication rate, fluid deficit, operating room turnover time

Detailed Description

Climate change will affect global health, with a disproportionate effect on women. To continue advocating for the patient population, it is necessary to decrease the carbon footprint of the medical field. The healthcare industry is responsible for many carbon emissions and waste generation. In a hospital, the operating room contributes 20-30% and uses 3-6 times more energy per square foot. There are growing attempts at "green" strategies to minimize the carbon footprint of surgery. Parts of this strategy include decreasing the amount of single-use supplies. From its production, transport, use, and disposal life cycle, single-use supplies contribute to a large amount to waste.

Hysteroscopies are a very common procedure with over 200,00 performed per year. hysteroscopy involves placing a camera into the uterus via the vagina and cervix. This can be performed for both diagnostic and therapeutic indications. Hysteroscopies have been classically performed in the operating room. In the operating room, there is an emphasis on maintaining the sterile field. The patient is prepped and draped, resulting in a large amount of excess drape usage. However, in-office hysteroscopies are gaining in popularity. In the office, draping is limited to the under buttock to capture the efflux. Institutions such as Newton Wellesley Hospital and Medstar Hospital systems all utilize minimal draping in the in-office setting.

There is no further sterile draping. There is not an increased risk of infections from in-office hysteroscopies. Overall, the rate of infections from hysteroscopy is very low ranging from 0.06- 0.18%. A study has shown that the usage of preoperative iodine in hysteroscopic in-office procedures does not decrease the postoperative infection rate. New studies focused on a minimal drape cystoscopy have also not shown any increase in infection rate.

The investigator and the team hypothesize that green draping for a hysteroscopy can decrease the operative time of a procedure without causing increased complications. This will also add to the procedure's decreased cost and carbon footprint.

Conditions

Hysteroscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Green Draping

This arm will follow the green draping procedures.

Group Type: EXPERIMENTAL

Green Draping Procedure

Intervention Type: PROCEDURE

The green draping will include only an under-buttock. After normal hand hygiene and scrub, the green draping procedure will have the surgeons don only a single pair of sterile gloves.

Full Draping

This arm will follow the conventional full draping procedures.

Group Type: ACTIVE_COMPARATOR

Full Draping Procedure

Intervention Type: PROCEDURE

The full draping will include under-buttocks, two-leg drapes, blue towels, and a top drape. After normal hand hygiene and scrub, the draping procedure will have the surgeon don a surgical gown and two sets of sterile gloves for the surgeon.

Interventions

Green Draping Procedure

The green draping will include only an under-buttock. After normal hand hygiene and scrub, the green draping procedure will have the surgeons don only a single pair of sterile gloves.

Intervention Type: PROCEDURE

Full Draping Procedure

The full draping will include under-buttocks, two-leg drapes, blue towels, and a top drape. After normal hand hygiene and scrub, the draping procedure will have the surgeon don a surgical gown and two sets of sterile gloves for the surgeon.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• All women undergoing a hysteroscopic procedure at Emory St Joseph's, Emory Dunwoody ASC, Emory University Hospital, Emory University Hospital ASC.

Exclusion Criteria

• Women undergoing a concomitant procedure along with the hysteroscopic procedure
• Pregnant women,
• Prisoners
• Cognitively impaired or Individuals with impaired decision-making capacity

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Michael Heit

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Heit, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Hospital

Atlanta, Georgia, United States

Emory Dunwoody Clinic

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY00007357

Identifier Type: -

Identifier Source: org_study_id