The Impact of a Redesigned Handout for Robotic Sacrocolpopexy on Patient Preoperative Preparedness and Satisfaction

NCT ID: NCT06934304

Last Updated: 2025-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Pelvic Organ Prolapse Patient Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Old preoperative handout

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

Group Type PLACEBO_COMPARATOR

old preoperative handout

Intervention Type OTHER

The old or standard preoperative handout for robotic sacrocolpopexy

New preoperative handout

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

Group Type EXPERIMENTAL

new preoperative handout

Intervention Type OTHER

A new preoperative handout for robotic sacrocolpopexy was designed at a lower reading level and providing more perioperative details

Interventions

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new preoperative handout

A new preoperative handout for robotic sacrocolpopexy was designed at a lower reading level and providing more perioperative details

Intervention Type OTHER

old preoperative handout

The old or standard preoperative handout for robotic sacrocolpopexy

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Texas, Southwestern Medical Center at Dallas

OTHER

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Christine Herforth

Urology Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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STU-2022-0305

Identifier Type: -

Identifier Source: org_study_id

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