Green Hysteroscopy

Hysteroscopy Clinical Trial

Official title:

Comparing Operative Times in Hysteroscopies With Full Draping vs Green Draping

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06379841
• Other study ID #: STUDY00007357
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Emory University
• Contact: Elissa Trieu, MD
• Phone: 404-778-3401
• Email: elissa.trieu[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hysteroscopy

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Emory Dunwoody Clinic	Atlanta	Georgia
United States	Emory Hospital	Atlanta	Georgia
United States	Emory Saint Joseph's Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in operative times	The principal investigator will begin timing the case on a stopwatch when the surgeon has finished scrubbing and reentered the operating room. The investigator will note the end time of the procedure as when the procedure has concluded, and the patient's legs are brought out of lithotomy back onto the bed.	Baseline
Secondary	Infection Rate	De-identified case report forms will be used for collection of perioperative data including total Infection rate.	Baseline, 2 weeks
Secondary	Post Operative complication Rate	De-identified case report forms will be used for collection of Post operative data including urinary tract infection, vaginal infection, intrauterine infection, abnormal postoperative bleeding.	Baseline, 2 weeks
Secondary	Peri operative Complication Rate	De-identified case report forms will be used for collection of perioperative data including total complication rate. The complication rate is a composite to include uterine perforation, fluid overload, hemorrhage, and air/gas embolism.	Baseline, 2 weeks
Secondary	Number of cases of Fluid deficits	De-identified case report forms will be used for collection of data including total number of patients with fluid deficits.	Baseline, 2 weeks
Secondary	Operative room turnover time in Full Draping	The OR turnover time will be calculated from the operating room status board as the difference between when the patient is out of the room and when the next patient is brought into the room.	Baseline