CancerNCT04844671
Patients' Expectations About Effects of Robotic Surgery for Cancer
An observational study of Cancer and Robotic Surgery, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer, Robotic Surgery, Patients' Expectations
- What is being tested?
- da Vinci Surgical Systems
- Type of treatment
- Medical device
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2021to 30 Jun 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Clinical diagnosis of Cancer
- Have undergone tumor resection with Da Vinci Robotic Surgery System
- Volunteer to participate in the study
Who cannot join
- Patients with mental illness
- Cognitive dysfunction
- Cannot complete the questionnaire independently
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xi'An Jiaotong University
Xi'an, Shaanxi, 70061
YONG ZHNAG, DR, 008613709110938, yongzhang761@mail.xjtu.edu.cn
Rui Jia, 008613576945538, jrdoc123@163.com
About this study
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.
Read the 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.
- Conditions
- Cancer, Robotic Surgery, Patients' Expectations
- Being tested
- da Vinci Surgical Systems
- Keywords
- Patients' Expectations, Robotic surgery, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
da Vinci Surgical SystemsDevice
The da Vinci Surgical Systems enable surgeons to perform delicate and complex operations through a few small incisions with robotic assisted surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2021.4-2022.4
Secondary outcomes (2)
Social demographic characteristics
Age, Sex, Education, Occupation
Measured: 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.
Measured: 2021.4-2022.4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start20 Apr 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yong Zhang, Study director, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844671
- Sponsor's protocol ID
- XJTU1AF2021LSK-068
- Status last verified
- Apr 2022
- First submitted
- 4 Apr 2021
- Last updated
- 28 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Study Protocol
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Expectations About Effects of Robotic Surgery for Cancer
- ClinicalTrials.gov ID
- NCT04844671
- Acronym / sponsor ID
- XJTU1AF2021LSK-068
- Conditions
- Cancer, Robotic Surgery, Patients' Expectations
- Keywords
- Patients' Expectations, Robotic surgery, Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Clinical diagnosis of Cancer
- Have undergone tumor resection with Da Vinci Robotic Surgery System
- Volunteer to participate in the study
Key exclusion criteria (3 listed)
- Patients with mental illness
- Cognitive dysfunction
- Cannot complete the questionnaire independently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| da Vinci Surgical SystemsThe da Vinci Surgical Systems enable surgeons to perform delicate and complex operations through a few small incisions with robotic assisted surgery. | Device | – |
Primary outcome
Factors Associated With Patients' Decisions Factors Associated With Patients'Decisions to Choose Robotic Surgery
Time frame: 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.
2 secondary outcomes
Social demographic characteristics
Time frame: 2021.4-2022.4
Economic status
Time frame: 2021.4-2022.4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: No. Study Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Zhang study director
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Robotic Surgery, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Zhang, DR (008685324610, yongzhang761@mail.xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors Associated With Patients' Decisions Factors Associated With Patients'Decisions to Choose Robotic Surgery (time frame: 2021.4-2022.4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.