HysteroscopyNCT06379841
Green Hysteroscopy
A study testing Green Draping Procedure and Full Draping Procedure in people with Hysteroscopy, run by Emory University at 3 sites in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hysteroscopy
- What is being tested?
- Green Draping Procedure and Full Draping Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Jul 2024to 14 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All women undergoing a hysteroscopic procedure at Emory St Joseph's, Emory Dunwoody ASC, Emory University Hospital, Emory University Hospital ASC.
Who cannot join
- Women undergoing a concomitant procedure along with the hysteroscopic procedure
- Pregnant women,
- Prisoners
- Cognitively impaired or Individuals with impaired decision-making capacity
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory Hospital
Atlanta, Georgia, 30322
Emory Dunwoody Clinic
Atlanta, Georgia, 30338
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
About this study
Official title: Comparing Operative Times in Hysteroscopies With Full Draping vs Green Draping
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
Read the 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
- Being tested
- Green Draping Procedure, Full Draping Procedure
- Keywords
- Surgical Draping, Hysteroscopy Draping, Draping Procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green Draping ProcedureProcedure or surgery
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 ProcedureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Green Draping | Experimental | This arm will follow the green draping procedures. Receives: Procedure: Green Draping Procedure |
| Full Draping | Active comparator | This arm will follow the conventional full draping procedures. Receives: Procedure: Full Draping Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (5)
Infection Rate
De-identified case report forms will be used for collection of perioperative data including total Infection rate.
Measured: Baseline, 2 weeks
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.
Measured: Baseline, 2 weeks
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.
Measured: Baseline, 2 weeks
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.
Measured: Baseline, 2 weeks
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start19 Jul 2024
- Primary completion29 May 2025
- Study completion14 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysteroscopyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Heit, Emory University
- Investigators
- Michael Heit, MD,PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379841
- Sponsor's protocol ID
- STUDY00007357
- Status last verified
- Jun 2025
- First submitted
- 18 Apr 2024
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Operative Times in Hysteroscopies With Full Draping vs Green Draping
- ClinicalTrials.gov ID
- NCT06379841
- Acronym / sponsor ID
- STUDY00007357
- Conditions
- Hysteroscopy
- Keywords
- Surgical Draping, Hysteroscopy Draping, Draping Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 14 Jun 2025 (actual)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Green Draping | Experimental | Procedure: Green Draping ProcedureThis arm will follow the green draping procedures. |
| Full Draping | Active comparator | Procedure: Full Draping ProcedureThis arm will follow the conventional full draping procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All women undergoing a hysteroscopic procedure at Emory St Joseph's, Emory Dunwoody ASC, Emory University Hospital, Emory University Hospital ASC.
Key exclusion criteria (4 listed)
- Women undergoing a concomitant procedure along with the hysteroscopic procedure
- Pregnant women,
- Prisoners
- Cognitively impaired or Individuals with impaired decision-making capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green Draping ProcedureThe 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. | Procedure or surgery | Green Draping |
| Full Draping ProcedureThe 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. | Procedure or surgery | Full Draping |
Primary outcome
Difference in operative times
Time frame: Baseline
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.
5 secondary outcomes
Infection Rate
Time frame: Baseline, 2 weeks
Post Operative complication Rate
Time frame: Baseline, 2 weeks
Peri operative Complication Rate
Time frame: Baseline, 2 weeks
Number of cases of Fluid deficits
Time frame: Baseline, 2 weeks
Operative room turnover time in Full Draping
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Heit, MD,PhD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green Draping Procedure and Full Draping Procedure in people with Hysteroscopy, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in operative times (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.