Comparison of Single Port and Two Ports Robotic Assisted Thoracic Surgery for Thymectomy
RATS
Randomized Open Label Two Arms Cohort Study to Evaluate Curative Effect and Quality of Life of Single Port and Two Ports Robotic Assisted Thoracic Surgery for Thymectomy
1 other identifier
interventional
60
1 country
1
Brief Summary
Recently, robotic-assisted thoracic surgery (RATS) has become into as an alternative approach to either, open surgery or video-assisted thoracoscopic surgery. The superiorities of RATS have been reported in series studies, such as intuitive movements, tremor filtration, more degrees of manipulative freedom, motion scaling, and high-definition stereoscopic vision. However, the currently reported robotic thymectomy used 3 ports. Theoretically, less incisions may bring faster postoperative recovery, lighter postoperative pain and higher postoperative quality of life. The investigators have successfully performed robotic thymectomy through 2 ports and even 1 port. However, the potential benefit of less ports robotic thymectomy has not been verified through well-designed cohort study, so this clinical trial has been designed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2022
CompletedFirst Posted
Study publicly available on registry
March 2, 2022
CompletedStudy Start
First participant enrolled
May 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedMay 24, 2022
May 1, 2022
2.1 years
January 16, 2022
May 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post operation pain
Measured with Visual Analogue Score (VAS-score)，the minimum value is 1, the maximum value is 10, higher scores mean a worse outcome.
1 month after surgery
Secondary Outcomes (4)
Surgical bleeding
During operation
Operation duration
During operation
Quality of life after surgery
6 months
Curative effect
5 years
Study Arms (2)
Thymectomy performed with sigle port RATS
EXPERIMENTALThe incision is performed in the 5-6th intercostal space under the breast folds without violating the mammalian tissue. This port is used for the camera and both arms simultaneously.
Thymectomy performed with two ports RATS
ACTIVE COMPARATORThe incision is performed in the 4th intercostal space along anterior axillary fossa, for the camera and left arm. The other incision is subxiphoid longitudinal incision about 4cm for the right arm.
Interventions
The incision is performed in the 5-6th intercostal space under the breast folds without violating the mammalian tissue. This port is used for the camera and both arms simultaneously.
The incision is performed in the 4th intercostal space along anterior axillary fossa, for the camera and left arm. The other incision is subxiphoid longitudinal incision about 4cm for the right arm.
Eligibility Criteria
You may qualify if:
- Patients with Myasthenia Gravis and(or) thymoma need to perform thymectomy.
- Agree to accept Robotic Assisted Thoracic Surgery and have signed informed consent.
You may not qualify if:
- Cardiopulmonary function cannot tolerate thoracoscopic surgery or exist other contraindication.
- Thymic carcinoma.
- Thoracic deformity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
Related Publications (4)
Peng M, Wang X, Chen C, Tan S, Liu W, Yu F. Report on 153 sequential three-incision robotic-assisted pulmonary resections by a single surgeon: technical details and learning curve. J Thorac Dis. 2020 Mar;12(3):741-748. doi: 10.21037/jtd.2019.12.116.
PMID: 32274140BACKGROUNDKaba E, Cosgun T, Ayalp K, Alomari MR, Toker A. Robotic thymectomy-a new approach for thymus. J Vis Surg. 2017 May 8;3:67. doi: 10.21037/jovs.2017.03.28. eCollection 2017.
PMID: 29078630BACKGROUNDCurcio C, Scaramuzzi R, Amore D. Robotic-assisted thoracoscopic surgery thymectomy. J Vis Surg. 2017 Nov 7;3:162. doi: 10.21037/jovs.2017.10.01. eCollection 2017.
PMID: 29302438BACKGROUNDLuzzi L, Corzani R, Ghisalberti M, Meniconi F, De Leonibus L, Molinaro F, Paladini P. Robotic surgery vs. open surgery for thymectomy, a retrospective case-match study. J Robot Surg. 2021 Jun;15(3):375-379. doi: 10.1007/s11701-020-01109-z. Epub 2020 Jul 6.
PMID: 32632562BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
January 16, 2022
First Posted
March 2, 2022
Study Start
May 10, 2022
Primary Completion
July 1, 2024
Study Completion
January 1, 2025
Last Updated
May 24, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share