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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05086406
Other study ID # FLA 21-022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2021
Est. completion date December 2024

Study information

Verified date June 2024
Source The Cleveland Clinic
Contact George K Thomas, MD
Phone 757-817-0353
Email thomasg6@ccf.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Compare preparedness for total laparoscopic hysterectomies between patients who undergo virtual visits and those who undergo in-office visits for pre-operative counseling.


Description:

The proposed research study looks to evaluate the effectiveness of combination of video counseling and virtual visits for pre-operative counseling as compared to in-office pre-operative counseling visits ahead of total laparoscopic hysterectomy surgery. Comparison of the two cohorts will be based on responses to surveys regarding patient preparedness on the day of surgery and information obtained from the electronic medical record.


Recruitment information / eligibility

Status Recruiting
Enrollment 128
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years and older
Eligibility Inclusion Criteria: - Patient undergoing laparoscopic hysterectomy for benign gynecologic etiologies. - Age of 20 years or older - Understand English language (written and spoken) without difficulty Exclusion Criteria: - Age less than 20 years old - Diagnosis of malignancy - No access to technology that would allow for watching counseling video and/or completion of virtual visit

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Combination of Video and Virtual Pre-operative Counseling
Intervention will be a pre-operative counseling video followed by a virtual visit with a gynecologic surgery provider, using standard and secure communications.

Locations

Country Name City State
United States Cleveland Clinic Florida Weston Florida

Sponsors (1)

Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (5)

Brubaker L, Litman HJ, Rickey L, Dyer KY, Markland AD, Sirls L, Norton P, Casiano E, Paraiso MF, Ghetti C, Rahn DD, Kusek JW. Surgical preparation: are patients "ready" for stress urinary incontinence surgery? Int Urogynecol J. 2014 Jan;25(1):41-6. doi: 10.1007/s00192-013-2184-x. Epub 2013 Aug 3. — View Citation

Fountain CR, Havrilesky LJ. Promoting Same-Day Discharge for Gynecologic Oncology Patients in Minimally Invasive Hysterectomy. J Minim Invasive Gynecol. 2017 Sep-Oct;24(6):932-939. doi: 10.1016/j.jmig.2017.05.005. Epub 2017 May 10. — View Citation

Greene KA, Wyman AM, Scott LA, Hart S, Hoyte L, Bassaly R. Evaluation of patient preparedness for surgery: a randomized controlled trial. Am J Obstet Gynecol. 2017 Aug;217(2):179.e1-179.e7. doi: 10.1016/j.ajog.2017.04.017. Epub 2017 Apr 18. — View Citation

Kenton K, Pham T, Mueller E, Brubaker L. Patient preparedness: an important predictor of surgical outcome. Am J Obstet Gynecol. 2007 Dec;197(6):654.e1-6. doi: 10.1016/j.ajog.2007.08.059. — View Citation

Krantz TE, Rogers RG, Petersen TR, Dunivan GC, White AB, Madsen AM, Jeppson PC, Ninivaggio CS, Cichowski SB, Komesu YM. Peer-Centered Versus Standard Physician-Centered Video Counseling for Midurethral Sling Surgery: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2020 Aug;26(8):470-476. doi: 10.1097/SPV.0000000000000784. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Differences in patient preparedness Assess differences in patient preparedness at the time of the surgery between patients who received video and virtual pre-operative counseling versus those who received in-person counseling. Up to time of surgery
Secondary Unplanned office or emergency department visit Observe how many patients from each cohort require an unplanned visit to the office or visit to the emergency department. Up to 6 weeks after surgery
Secondary Same-day discharge versus admission rates Note differences in same-day discharges or admission rates following surgery between each cohort Up to 1 day after surgery
Secondary Readmission rates Record differences in readmission rates in the 6 week post-operative period between each cohort. Up to 6 weeks after surgery
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