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Comparison of Single Port and Two Ports Robotic Assisted Thoracic Surgery for Thymectomy (RATS)

Primary Purpose

Thymoma, Myasthenia Gravis Associated With Thymoma, Thymectomy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sigle port RATS
Two ports RATS
Sponsored by
Shanghai Pulmonary Hospital, Shanghai, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thymoma focused on measuring Thymoma, Myasthenia Gravis, Thymectomy, Robotic Assisted Thoracic Surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with Myasthenia Gravis and(or) thymoma need to perform thymectomy.
  2. Agree to accept Robotic Assisted Thoracic Surgery and have signed informed consent.

Exclusion Criteria:

  1. Cardiopulmonary function cannot tolerate thoracoscopic surgery or exist other contraindication.
  2. Thymic carcinoma.
  3. Thoracic deformity.

Sites / Locations

  • Shanghai Pulmonary HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Thymectomy performed with sigle port RATS

Thymectomy performed with two ports RATS

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Surgical bleeding
Surgical bleeding measured with milliliter
Operation duration
Operation duration measured with minute
Quality of life after surgery
Measured with European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core30 (EORTC QLQ-C30 questionnaire), the higher scores mean a better outcome.
Curative effect
Disease free survival 5 years after surgery

Full Information

First Posted
January 16, 2022
Last Updated
May 18, 2022
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
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1. Study Identification

Unique Protocol Identification Number
NCT05262582
Brief Title
Comparison of Single Port and Two Ports Robotic Assisted Thoracic Surgery for Thymectomy
Acronym
RATS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Pulmonary Hospital, Shanghai, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
The gold standard technique for thymectomy used to be transsternal approach. Advancements in modern technology bring many evolutions in minimally invasive surgery such as Video-assisted thoracic surgery (VATS) thymectomy gained popularity after 2000s. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thymoma, Myasthenia Gravis Associated With Thymoma, Thymectomy
Keywords
Thymoma, Myasthenia Gravis, Thymectomy, Robotic Assisted Thoracic Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thymectomy performed with sigle port RATS
Arm Type
Experimental
Arm Description
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.
Arm Title
Thymectomy performed with two ports RATS
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sigle port RATS
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Two ports RATS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post operation pain
Description
Measured with Visual Analogue Score (VAS-score),the minimum value is 1, the maximum value is 10, higher scores mean a worse outcome.
Time Frame
1 month after surgery
Secondary Outcome Measure Information:
Title
Surgical bleeding
Description
Surgical bleeding measured with milliliter
Time Frame
During operation
Title
Operation duration
Description
Operation duration measured with minute
Time Frame
During operation
Title
Quality of life after surgery
Description
Measured with European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core30 (EORTC QLQ-C30 questionnaire), the higher scores mean a better outcome.
Time Frame
6 months
Title
Curative effect
Description
Disease free survival 5 years after surgery
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with Myasthenia Gravis and(or) thymoma need to perform thymectomy. Agree to accept Robotic Assisted Thoracic Surgery and have signed informed consent. Exclusion Criteria: Cardiopulmonary function cannot tolerate thoracoscopic surgery or exist other contraindication. Thymic carcinoma. Thoracic deformity.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
lei jiang, doctor
Phone
+8613917912348
Email
jiangleiem@aliyun.com
Facility Information:
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lei jiang, doctor
Phone
13917912348
Email
jiangleiem@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32274140
Citation
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.
Results Reference
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PubMed Identifier
29078630
Citation
Kaba 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.
Results Reference
background
PubMed Identifier
29302438
Citation
Curcio 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.
Results Reference
background
PubMed Identifier
32632562
Citation
Luzzi 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.
Results Reference
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Comparison of Single Port and Two Ports Robotic Assisted Thoracic Surgery for Thymectomy

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