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Virtual Postoperative Care for Pelvic Surgery (VIDEO Trial)
N/A
Waitlist Available
Led By Cecile A Ferrando, M.D., M.P.H.
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
VIDEO Trial Summary
This trial will help understand how virtual visits compare to in-person visits for post-surgery care & patient satisfaction. It will also look at healthcare quality, resource use & patient/provider attitudes.
Who is the study for?
This trial is for women over 18 who've had urogynecologic surgery, can use videoconferencing tech (like high-speed internet and a computer or mobile device), speak English, and can consent to research. It's not for those who prefer in-person visits, have other planned surgeries, or need office follow-up as decided by their doctor.Check my eligibility
What is being tested?
The study compares patient satisfaction with virtual video visits to traditional in-office visits after pelvic organ prolapse/anti-incontinence surgery. It measures satisfaction using a questionnaire and looks at safety and clinical outcomes like healthcare resource use and adverse events up to 12 weeks post-surgery.See study design
What are the potential side effects?
Since this trial involves standard postoperative care through either virtual or in-office visits rather than medication or invasive procedures, there are no direct side effects associated with the interventions being tested.
VIDEO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient satisfaction
Secondary outcome measures
Adverse events
Patient preferences/attitudes toward virtual or office visits
Provider preferences/attitudes toward virtual or office visits
+1 moreVIDEO Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual VisitExperimental Treatment1 Intervention
Patients randomized to the experimental arm will be scheduled for and follow up with the surgeon or an advanced practice provider via a virtual visit using videoconference technology at 6 weeks after the anticipated date of surgery. If the surgery were to be rescheduled to a future date, the postoperative visit will be moved accordingly to ensure follow-up occurs at the 6-week postoperative period.
Group II: Office VisitActive Control1 Intervention
Patients randomized to the active comparator arm will be scheduled for and follow up with the surgeon or an advanced practice provider via an in-office visit at 6 weeks after the planned date of surgery. If the surgery were to be rescheduled to a future date, the postoperative visit will be moved accordingly to ensure follow-up occurs at the 6-week postoperative period.
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Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,026 Previous Clinical Trials
1,365,968 Total Patients Enrolled
Cecile A Ferrando, M.D., M.P.H.Principal InvestigatorThe Cleveland Clinic
1 Previous Clinical Trials
148 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can attend my postoperative visit in person or virtually.My doctor says I need to have follow-up visits at the office.I am older than 18 years.I can make my own decisions and agree to participate in research.I am scheduled for surgery that involves more than one surgical team.
Research Study Groups:
This trial has the following groups:- Group 1: Office Visit
- Group 2: Virtual Visit
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitment efforts still underway for this trial?
"Based on information listed on clinicaltrials.gov, this trial is not accepting applications at the present moment. The medical experiment was first posted in January 1st 2023 and its most recent update occurred December 7th 2022. Nevertheless, 44 other studies are recruiting patients right now."
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