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

Thymoma Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05262582
• Other study ID #: jianglei4
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: May 2022
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: lei jiang, doctor
• Phone: +8613917912348
• Email: jiangleiem[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 1, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myasthenia Gravis
• Myasthenia Gravis Associated With Thymoma
• Thymectomy
• Thymoma
• Thymus Neoplasms

Intervention

Procedure:
• Sigle port RATS
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.
• Two ports RATS
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.

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

References & Publications (4)

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. Review. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Surgical bleeding	Surgical bleeding measured with milliliter	During operation
Secondary	Operation duration	Operation duration measured with minute	During operation
Secondary	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.	6 months
Secondary	Curative effect	Disease free survival 5 years after surgery	5 years