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

Shanghai Pulmonary Hospital, Shanghai, China

Status: Enrolling

Conditions: Thymoma; Thymectomy; Myasthenia Gravis Associated With Thymoma

Treatments: Procedure: Sigle port RATS; Procedure: Two ports RATS

Study type: Interventional

Funder types: Other

Identifiers

NCT05262582

jianglei4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Thymectomy performed with sigle port RATS

Experimental group

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.

Treatment:

Procedure: Sigle port RATS

Thymectomy performed with two ports RATS

Active Comparator group

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.

Treatment:

Procedure: Two ports RATS