to Determine Whether Patient Satisfaction With Postoperative Telehealth Follow-up is Non-inferior to In-person Clinic VisitsTelehealth RCTNCT07420114
Outpatient Visits Versus Telehealth for Postoperative Care After Minimally Invasive Gynecologic Surgery
An observational study of to Determine Whether Patient Satisfaction With Postoperative Telehealth Follow-up is Non-inferior to In-person Clinic Visits, run by University of Chicago at 2 sites in United States.
Trial summary
Telehealth, or telemedicine, utilizes technology to deliver clinical care remotely, either in real time or asynchronously, between clinician and patient. Telemedicine has been successfully implemented to increase healthcare delivery for patients in rural areas with otherwise long travel times, and studies have also… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- to Determine Whether Patient Satisfaction With Postoperative Telehealth Follow-up is Non-inferior to In-person Clinic Visits
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jul 2026to Dec 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women over the age of 18 and scheduled for a minimally invasive gynecologic surgery (laparoscopic or robotic surgeries including: excision of endometriosis, adnexal surgery with oophorectomy or cystectomy, myomectomy, or hysterectomy.)
Who may be able to join
- Participant has provided written informed consent.
- Women over the age of 18.
- Ability for patients to complete telehealth visits (i.e. working telephone or internet access) and speak and understand English.
- Laparoscopic or robotic surgeries including: excision of endometriosis, adnexal surgery with oophorectomy or cystectomy, myomectomy, and hysterectomy.
- Undergoing minimally invasive gynecologic surgeries with complex pelvic surgeons (AAGL fellowship-trained).
Who cannot join
- Conversion to open surgery.
- Malignancy noted intraoperatively or on final pathology evaluation.
- Surgeon or patient preference for in person clinic follow up.
- Pregnancy - pregnancy tests will be completed as part of routine preoperative care on the day of surgery
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sumeyra Agambayev, MS contact
United States2 sites, 2 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Sumeyra Agambayev, MS, 773-834-9425, sagambay@uchicago.edu
- Not yet recruiting
UChicago Medicine Advent Hinsdale
Hinsdale, Illinois, 60521
Josef Jackson, MD, 773-834-0598, josef.jackson@uchicagomedicine.org
Laura Douglass, MD
About this study
Official title: Outpatient Visits Versus Telehealth for Postoperative Care After Minimally Invasive Gynecologic Surgery: A Randomized Controlled Trial
Telehealth, or telemedicine, utilizes technology to deliver clinical care remotely, either in real time or asynchronously, between clinician and patient. Telemedicine has been successfully implemented to increase healthcare delivery for patients in rural areas with otherwise long travel times, and studies have also determined that telemedicine can increase patient satisfaction scores while simultaneously decreasing direct and indirect costs for patients.
Previous scholarship has demonstrated that telemedicine can be a safe alternative to face-to-face postoperative visits for surgical patients, streamlining recovery with no significant delays in the diagnosis of surgical complications. As healthcare systems continue to emphasize value-based care, it is important to assess whether virtual postoperative visits effectively meet patient needs while optimizing resource utilization.
Patient-reported outcomes and satisfaction surveys can help identify potential gaps in care and ensure that telehealth is implemented in a way to maximize both efficiency and quality. Our primary objective is to determine whether patient satisfaction with postoperative telehealth follow-up is non-inferior to in-person clinic visits.
- Keywords
- telehealth, minimally invasive gynecologic surgery, hysterectomy, myomectomy, excision of endometriosis, laparoscopic surgeries, robotic surgeries, adnexal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| control group | in person clinic visits | |
| experimental group | virtual visits ((telephone or video) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with surgery and postoperative visits
Satisfaction scores will be compiled from participant responses to the Surgical-Consumer Assessment of Healthcare Providers and Systems (S-CAHPS) questionnaire. This questionnaire was developed by the American College of Surgeons and includes seven composites: (1) information to help prepare for surgery, (2) surgeon communication preoperatively, (3) surgeon attentiveness on the day of surgery, (4) information to help during recovery, (5) surgeon communication after surgery, (6) qualities of office staff, and (7) an overall surgeon rating. Specific attention will be paid to participant ratings of items 4, 5, and 7.
Measured: 3 months
Patient satisfaction with virtual care delivery
Satisfaction scores will be compiled from responses to the Telehealth Usability Questionnaire (TUQ): a validated tool of 21 questions used to assess patients' and providers' perceptions of telehealth systems. It evaluates domains such as ease of use, interface quality, interaction quality, reliability, and overall satisfaction, providing a structured way to measure and improve telehealth user experience (graded on a 5-point Likert scale).
Measured: 3 months
Secondary outcomes (3)
Additional healthcare utilization and adverse events
Patient safety will be gauged by proxy via measurement of additional healthcare utilization by participants during the follow-up interval; specifically, the number of hospital re-admissions, emergency department or urgent care visits, and unscheduled clinic visits. Additionally, incidence of reoperation, blood transfusion, and wound infections will be tracked.
Measured: 3 months
Incidence of common postoperative outcomes
Clinical outcomes will be evaluated by a standardized institutional postoperative questionnaire which queries patients about common postoperative symptoms including return of bowel function, return of appetite, use of additional pain medications, fevers, and vaginal bleeding.
Measured: 3 months
Postoperative pain
Pain scores will be tabulated using the Short-form McGill Pain Questionnaire 2
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start31 Jul 2026
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for to Determine Whether Patient Satisfaction With Postoperative Telehealth Follow-up is Non-inferior to In-person Clinic VisitsStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Douglass, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420114
- Sponsor's protocol ID
- IRB25-1847
- Acronym
- Telehealth RCT
- Status last verified
- Aug 2026
- First submitted
- 7 Jan 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No current plan to share data.