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

Sponsor
Shanghai Pulmonary Hospital, Shanghai, China (Other)
Overall Status
Recruiting
CT.gov ID
NCT05262582
Collaborator
(none)
60
1
2
31.8
1.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Sigle port RATS
  • Procedure: Two ports RATS
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 10, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Thymectomy performed with 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.

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.

Active Comparator: Thymectomy performed with 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.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Surgical bleeding [During operation]

    Surgical bleeding measured with milliliter

  2. Operation duration [During operation]

    Operation duration measured with minute

  3. 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.

  4. Curative effect [5 years]

    Disease free survival 5 years after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Pulmonary Hospital Shanghai Shanghai China 200433

Sponsors and Collaborators

  • Shanghai Pulmonary Hospital, Shanghai, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Lei Jiang, principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier:
NCT05262582
Other Study ID Numbers:
  • jianglei4
First Posted:
Mar 2, 2022
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lei Jiang, principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2022