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

Not Applicable

Recruiting

• Conditions: Thymectomy; Thymoma; Myasthenia Gravis Associated With Thymoma
• Interventions: Procedure: Sigle port RATS; Procedure: Two ports RATS

• Registration Number: NCT05262582
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

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.

Study Timeline

• Study First Submitted: 2022-01-16
• Study First Submitted QC: 2022-02-20
• Study First Posted: 2022-03-02
• Status Verified: 2022-05
• Study Start: 2022-05-10
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-24
• Primary Completion: 2024-07-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thymectomy performed with sigle port RATS	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.
Thymectomy performed with two ports RATS	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.

Primary Outcome Measures

Name	Time	Method
Post operation pain	1 month after surgery	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

Name	Time	Method
Operation duration	During operation	Operation duration measured with minute
Quality of life after surgery	6 months	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	5 years	Disease free survival 5 years after surgery
Surgical bleeding	During operation	Surgical bleeding measured with milliliter

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China