Study Summary
This trial compares the preparedness of patients for a total laparoscopic hysterectomy procedure depending on whether they had a virtual visit or an in-office visit for pre-operative counseling.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: Up to time of surgery
Day 1
Same-day discharge versus admission rates
Week 6
Readmission rates
Unplanned office or emergency department visit
Up to time of surgery
Differences in patient preparedness
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
In-Office Visit Group
1 of 2
Virtual Visit Group
1 of 2
Active Control
Experimental Treatment
128 Total Participants · 2 Treatment Groups
Primary Treatment: Combination of Video and Virtual Pre-operative Counseling · No Placebo Group · N/A
Virtual Visit Group
Other
Experimental Group · 1 Intervention: Combination of Video and Virtual Pre-operative Counseling · Intervention Types: OtherIn-Office Visit GroupNoIntervention Group · 1 Intervention: In-Office Visit Group · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to time of surgery
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
949 Previous Clinical Trials
1,409,645 Total Patients Enrolled
Katrin Arnolds, MDPrincipal InvestigatorCleveland Clinic Florida Gynecology
Eligibility Criteria
Age 18+ · Female Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Patient undergoing laparoscopic hysterectomy for benign gynecologic etiologies.
References
- Greene, Kristie A., Allison M. Wyman, Lauren A. Scott, Stuart Hart, Lennox Hoyte, and Renee Bassaly. 2017. “Evaluation of Patient Preparedness for Surgery: A Randomized Controlled Trial”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2017.04.017.
- Fountain, Cynthia R., and Laura J. Havrilesky. 2017. “Promoting Same-day Discharge for Gynecologic Oncology Patients in Minimally Invasive Hysterectomy”. Journal of Minimally Invasive Gynecology. Elsevier BV. doi:10.1016/j.jmig.2017.05.005.
- Krantz, Tessa E., Rebecca G. Rogers, Timothy R. Petersen, Gena C. Dunivan, Amanda B. White, Annetta M. Madsen, Peter C. Jeppson, Cara S. Ninivaggio, Sara B. Cichowski, and Yuko M. Komesu. 2020. “Peer-centered Versus Standard Physician-centered Video Counseling for Midurethral Sling Surgery: A Randomized Controlled Trial”. Female Pelvic Medicine & Reconstructive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/spv.0000000000000784.
- Brubaker, L., H. J. Litman, L. Rickey, K. Y. Dyer, A. D. Markland, L. Sirls, P. Norton, et al.. 2013. “Surgical Preparation: Are Patients “ready” for Stress Urinary Incontinence Surgery?”. International Urogynecology Journal. Springer Science and Business Media LLC. doi:10.1007/s00192-013-2184-x.
- Kenton, Kimberly, Thythy Pham, Elizabeth Mueller, and Linda Brubaker. 2007. “Patient Preparedness: An Important Predictor of Surgical Outcome”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2007.08.059.
- 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.
- 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.
- 2021. "Virtual and Video Counseling Versus In-Office Counseling for Laparoscopic Hysterectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05086406.
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