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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot assisted thoracic surgery | Experimental | RATS |
|
| Video assisted thoracic surgery | Active Comparator | VATS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot assited thoracic surgery | Procedure | The lobectomy will be preformed in case of an operable lung cancer. The thoracic surgery technique used is robot assisted thoracic surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | 0 = no pain 10 = unbearable pain: VASscore | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| blood loss | ml | up to 4 hours |
| operative time | duration of surgery | up to 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Veerle Van Mossevelde, data nurse | Contact | +3224763134 | veerle.vanmossevelde@uzbrussel.be | |
| Dirk De Clippeleir, data nurse | Contact | +3224763580 | dirk.declippeleir@uzbrussel.be |
| Name | Affiliation | Role |
|---|---|---|
| Wietske Renckens, MD | Universitair Ziekenhuis Brussel | Study Chair |
| Dirk Smets, MD | Universitair Ziekenhuis Brussel | Principal Investigator |
| Eef Vanderhelst, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Recruiting | Jette | Brussels Capital | 1090 | Belgium |
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|
| Video assited thoracic surgery | Procedure | The lobectomy will be preformed in case of an operable lung cancer. The thoracic surgery technique used is video assisted thoracic surgery. |
|
|
| 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 |
| Universitair Ziekenhuis Brussel |
| Study Director |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D010149 | Pain, Postoperative |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D020775 | Thoracic Surgery, Video-Assisted |
| ID | Term |
|---|---|
| D013906 | Thoracoscopy |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D020535 | Video-Assisted Surgery |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |
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