Patients' Expectations About Effects of Robotic Surgery for Cancer

Robotic surgery for common surgical procedures is on the rise despite limited evidence to support its clinical benefit. We intend to to map and characterize the prevalence of the patients'expectation that robotic surgery might be superior to open or laparoscopic procedures and to identify the sociodemographic, clinical and organisational factors associated with this expectation.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Robotic Surgery; Patients' Expectations
• Intervention / Treatment: Device: da Vinci Surgical Systems

Detailed Description

With the progress of modern medicine, minimally invasive surgical technology has become the main theme in the field of contemporary surgery. As a rising star, the Da Vinci robotic surgery system provides surgeons with a more comprehensive surgical vision, more flexible instrument control, finer anatomy, and more natural comfort compared to open surgery and laparoscopic surgery. However, due to the lack of long-term theoretical basis, the evidence to support its clinical benefits is limited, and its application is limited by related postoperative complications and high operation-related costs. At present, the number of Da Vinci robotic surgery is steadily increasing around the world, but what are the expectations of patients that robotic surgery may be better than open or laparoscopic surgery? It is also unclear what reasons are related to this established expectation. Therefore, we intend to map and characterize the prevalence of the patients' expectation that robotic surgery might be superior to open or laparoscopic procedures and to identify the sociodemographic, clinical and organisational factors associated with this expectation.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Yong Zhang, DR; Phone Number: 008685324610; Email: yongzhang761@mail.xjtu.edu.cn
• Study Contact Backup: Name: Rui Jia; Phone Number: 008613576945538; Email: jrdoc123@163.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 70061
      • Recruiting
      • The First Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Rui Jia; Phone Number: 008613576945538; Email: jrdoc123@163.com
      • Contact: YONG ZHNAG, DR; Phone Number: 008613709110938; Email: yongzhang761@mail.xjtu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients who have undergone Da Vinci robotic surgery in the first affiliated hospital of Xi'an Jiaotong University in the past five years

Description

Inclusion Criteria:

• Clinical diagnosis of Cancer
• Have undergone tumor resection with Da Vinci Robotic Surgery System
• Volunteer to participate in the study

Exclusion Criteria:

• Patients with mental illness
• Cognitive dysfunction
• Cannot complete the questionnaire independently

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors Associated With Patients' Decisions Factors Associated With Patients'Decisions to Choose Robotic Surgery	Factors Associated With Patients'Trends in the Adoption of Robotic Surgery for Common Surgical Procedures。According to the relevant regulations of the hospital inpatient satisfaction survey, we have developed a satisfaction rating scale, the evaluation is divided into five grades: "very satisfied" = 5, "relatively satisfied" = 4, "general" = 3, "not very satisfied" = 2, "very dissatisfied" = 1, the total score is 1-5.	2021.4-2022.4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social demographic characteristics	Age, Sex, Education, Occupation	2021.4-2022.4
Economic status	The ability to pay for medical expenses and the type of medical insurance.Based on the types of medical insurance in China, our survey design is divided into four categories: 1. China new rural cooperative medical system; 2. The medical insurance for urban residents; 3. The medical insurance for urban workers; 4. Commercial insurance. According to China's national income level, our survey design is divided into three stages: personal annual income below 50,000 RMB, 50,000-100,000 RMB, and more than 100,000 RMB.	2021.4-2022.4

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Study Director: Yong Zhang, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: April 4, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Patients' Expectations; Robotic surgery
• Other Study ID Numbers: XJTU1AF2021LSK-068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes