Clinical trial NCT06379841: Green Hysteroscopy
Official title: Comparing Operative Times in Hysteroscopies With Full Draping vs Green Draping
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hysteroscopy
Keywords: Surgical Draping
Hysteroscopy Draping
Draping Procedures
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Difference in operative times
timeFrame: Baseline
Secondary outcomes:
measure: Infection Rate
timeFrame: Baseline, 2 weeks
measure: Post Operative complication Rate
timeFrame: Baseline, 2 weeks
measure: Peri operative Complication Rate
timeFrame: Baseline, 2 weeks
measure: Number of cases of Fluid deficits
timeFrame: Baseline, 2 weeks
measure: Operative room turnover time in Full Draping
timeFrame: Baseline
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory Dunwoody Clinic
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Michael Heit, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: