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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06379841
Other study ID # STUDY00007357
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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