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Virtual and Video Counseling Versus In-Office Counseling for Laparoscopic Hysterectomy

Virtual and Video Counseling Versus In-Office Counseling for Laparoscopic Hysterectomy: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05086406
Enrollment
128
Registered
2021-10-20
Start date
2021-05-01
Completion date
2025-12-31
Last updated
2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Engagement

Keywords

Patient Preparedness, Total Laparoscopic Hysterectomy, Pre-operative Education, Virtual Visits/Counseling

Brief summary

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

Detailed 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.

Interventions

OTHERCombination 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.

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Patients undergoing a laparoscopic hysterectomy for benign gynecologic etiologies with Drs. Arnolds, Frazzini Padilla, or Sprague at Cleveland Clinic Florida Section of Minimally Invasive Gynecologic Surgery will be recruited at the visit where decision is made to proceed with surgery. Enrolled subjects will be randomized using a computer generator into either the control group or the study group. Subjects will be notified of which group they have been selected to at the time of scheduling for their pre-operative visit. The control group will undergo standard in-office pre-operative counseling visit. The study group will receive pre-operative counseling via video followed by a virtual visit with a gynecologic surgery provider, using standard and secure communications that are currently approved by Cleveland Clinic. The link to the video and instructions for the virtual visit will be sent to the subject either via email and/or through a message on the electronic medical record platform.

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Differences in patient preparednessUp to time of surgeryAssess 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.

Secondary

MeasureTime frameDescription
Unplanned office or emergency department visitUp to 6 weeks after surgeryObserve how many patients from each cohort require an unplanned visit to the office or visit to the emergency department.
Same-day discharge versus admission ratesUp to 1 day after surgeryNote differences in same-day discharges or admission rates following surgery between each cohort
Readmission ratesUp to 6 weeks after surgeryRecord differences in readmission rates in the 6 week post-operative period between each cohort.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026