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Clinical Trials/NCT06934304
NCT06934304CompletedNot Applicable

Randomized Controlled Study on Patient Preoperative Preparedness and Satisfaction Using a Redesigned Handout for Robotic Sacrocolpopexy

University of Texas Southwestern Medical Center1 site in 1 country51 target enrollmentStarted: August 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
51
Locations
1
Primary Endpoint
Patient preparedness

Study Overview

Brief Summary

The goal of this clinical trial is to learn if a new preoperative handout for patients undergoing robotic sacrocolpopexy will improve patient sense of preparedness and satisfaction in comparison to the previously used handout. The main questions it aims to answer are:

  • Does the new preoperative handout for patients undergoing robotic sacrocolpopexy improve patient preparedness and satisfaction?
  • Will the new preoperative handout for patients undergoing robotic sacrocolpopexy impact postoperative queries in the form of phone calls and messages to the clinic?

Participants will:

  • Receive routine counseling regarding robotic sacrocolpopexy from their surgeon
  • Be randomized to the new or old preoperative handout
  • Undergo robotic sacrocolpopexy
  • Complete a questionnaire at their 4 week postoperative follow up visit regarding their sense of preparedness for surgery and overall satisfaction

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •women who were to undergo robotic sacrocolpopexy with or without supracervical hysterectomy, rectopexy, salpingectomy, urinary incontinence procedures, or other minor procedures.

Exclusion Criteria

  • •patients unable to provide informed consent, those undergoing other concomitant major abdominal surgeries, patients less than 18 years old, pregnant patients, non-English speaking patients, and patients planning postoperative follow up at an outside facility.

Arms & Interventions

Old preoperative handout

Placebo Comparator

Standard or old preoperative handout for robotic sacrocolpopexy was based off of the handout for robotic sacrocolpopexy from the American Urogynecologic Society

Intervention: old preoperative handout (Other)

New preoperative handout

Experimental

A new preoperative handout for robotic sacrocolpopexy was designed by changing the old preoperative handout such that it was written at a lower grade reading level and provided more perioperative details

Intervention: new preoperative handout (Other)

Outcomes

Primary Outcomes

Patient preparedness

Time Frame: Assessed at the postoperative visit 4 to 6 weeks after srugery

Patients sense of preparedness for robotic sacrocolpopexy was measured with a series of 5 point Likert style questions (ranging strongly disagree to strongly agree). Specifically, patients were asked how satisfied the were with 1) information provided by their surgeon, 2) time spent with the patient preparing them for surgery, 3) overall sense of sense of preparedness.

Secondary Outcomes

  • patient satisfaction(4 week postoperatively)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christine Herforth

Urology Fellow

University of Texas Southwestern Medical Center

Study Sites (1)

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