Patients' Expectations About Effects of Robotic Surgery for Cancer

Sponsor
First Affiliated Hospital Xi'an Jiaotong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04844671
Collaborator
(none)
3,000
1
14.3
209.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
3000 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Patients' Expectations About Effects of Robotic Surgery for Cancer
Actual Study Start Date :
Apr 20, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Outcome Measures

Primary Outcome Measures

  1. Factors Associated With Patients' Decisions Factors Associated With Patients'Decisions to Choose Robotic Surgery [2021.4-2022.4]

    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.

Secondary Outcome Measures

  1. Social demographic characteristics [2021.4-2022.4]

    Age, Sex, Education, Occupation

  2. Economic status [2021.4-2022.4]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Xi'An Jiaotong University Xi'an Shaanxi China 70061

Sponsors and Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier:
NCT04844671
Other Study ID Numbers:
  • XJTU1AF2021LSK-068
First Posted:
Apr 14, 2021
Last Update Posted:
Apr 28, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by First Affiliated Hospital Xi'an Jiaotong University

Study Results

No Results Posted as of Apr 28, 2022