Comparison of Robot Assisted Thoracic Surgery With Video Assisted Thoracic Surgery in Case of Lung Cancer

Study Overview
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Brief Summary
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In this study the investigator will compare the effectiveness of robot assisted thoracic surgery (RATS) with video assisted thoracic surgery (VATS) in case of lung cancer. The perioperative circumstances and postoperative outcome will be compared.

Detailed Description
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Participants are randomly subdivided (1:1) to either undergo robot assisted lobectomy or video assisted thoracoscopic lobectomy in case of lung cancer. At the end of both surgical interventions the anaesthesiologist administers the same technique of pain relief: paravertebral blockage. The data that are going to be investigated are: operative time, conversion to spreading of the ribs/thoracotomy, blood loss, lymph node dissection, prolonged air leak, chest tube drainage, length of stay, inflammatory reaction (through inflammatory parameters CRP, IL-3, IL-6, TNF), lung recuperation (through a lung function test) and postoperative pain (VAS score questionnaire).

Official Title
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Comparison of Robot Assisted Thoracic Surgery With Video Assisted Thoracic Surgery in Case of Lung Cancer: a Prospective Trial With Control Group

Conditions
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Lung Cancer, Postoperative Pain, Blood Loss, Inflammatory Response

Intervention / Treatment
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* Procedure: Robot assited thoracic surgery
* Procedure: Video assited thoracic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be 18 years old or older Patients can be male or female Patients with a lung tumour which is treatable with surgery Exclusion Criteria: Pregnancy Inoperable lung tumour Patients which are at risk for general anaesthesia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot assisted thoracic surgery<br>RATS | Procedure: Video assited thoracic surgery<br>* The lobectomy will be preformed in case of an operable lung cancer. The thoracic surgery technique used is video assisted thoracic surgery.<br>* Other names: VATS;|
| Active Comparator: Video assisted thoracic surgery<br>VATS | Procedure: Robot assited thoracic surgery<br>* The lobectomy will be preformed in case of an operable lung cancer. The thoracic surgery technique used is robot assisted thoracic surgery<br>* Other names: RATS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | 0 = no pain 10 = unbearable pain: VASscore | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss | ml | up to 4 hours | 
| operative time | duration of surgery | up to 4 hours | 
| conversion to spreading of the ribs/thoracotomy | 0 = no 1 = yes | up to 4 hours | 
| lymph node dissection | number of lymph nodes | up to 4 hours | 
| prolonged air leak | chest tube present longer than usual | up to 7 days | 
| chest tube drainage | ml | up to 7 days | 
| length of stay | duration of hospitalisation after surgery | up to 7 days | 
| pulmonary function | recovery of function of the operated lung | 2 months | 
| Inflammatory reaction | these inflammatory parameters will be determined: C-reactive protein; IL-3; IL-6; TNF | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thoracoscopic surgery, RATS, VATS, Robot