Patients' Expectations About Effects of Robotic Surgery for Cancer

Cancer Clinical Trial

Official title:

Patients' Expectations About Effects of Robotic Surgery for Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04844671
• Other study ID #: XJTU1AF2021LSK-068
• Status: Recruiting
• Start date: April 20, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yong Zhang, DR
• Phone: 008685324610
• Email: yongzhang761[@]mail.xjtu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: June 30, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Patients' Expectations
• Robotic Surgery

Intervention

Device:
• da Vinci Surgical Systems
The da Vinci Surgical Systems enable surgeons to perform delicate and complex operations through a few small incisions with robotic assisted surgery.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xi'An Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Social demographic characteristics	Age, Sex, Education, Occupation	2021.4-2022.4
Secondary	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