Green Hysteroscopy

NCT06379841 | Completed

• 1 other identifier: STUDY00007357
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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

Conditions

Hysteroscopy

Keywords

Surgical Draping; Hysteroscopy Draping; Draping Procedures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Infection Rate

  Baseline, 2 weeks

• Post Operative complication Rate

  Baseline, 2 weeks

• Peri operative Complication Rate

  Baseline, 2 weeks

• Number of cases of Fluid deficits

  Baseline, 2 weeks

• Operative room turnover time in Full Draping

  Baseline

Study Arms (2)

Green Draping

EXPERIMENTAL

This arm will follow the green draping procedures.

Procedure: Green Draping Procedure

Full Draping

ACTIVE COMPARATOR

This arm will follow the conventional full draping procedures.

Procedure: Full Draping Procedure

Interventions

Green Draping Procedure 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.

Green Draping

Full Draping Procedure 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.

Full Draping

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead

Study Sites (3)

Emory Hospital

Atlanta, Georgia, 30322, United States

Location

Emory Dunwoody Clinic

Atlanta, Georgia, 30338, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Study Officials

• Michael Heit, MD,PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: July 19, 2024
• Primary Completion: May 29, 2025
• Study Completion: June 14, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)