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临床试验/NCT06934304
NCT06934304已完成不适用

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

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2022年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
Patient preparedness

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

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

干预措施: 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

干预措施: new preoperative handout (Other)

结局指标

主要结局

Patient preparedness

时间窗: 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.

次要结局

  • patient satisfaction(4 week postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christine Herforth

Urology Fellow

University of Texas Southwestern Medical Center

研究点 (1)

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