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

Not Applicable

• Conditions: Inflammatory Response; Postoperative Pain; Blood Loss; Lung Cancer
• Interventions: Procedure: Video assited thoracic surgery; Procedure: Robot assited thoracic surgery

• Registration Number: NCT03152071
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-05-11
• Study First Posted: 2017-05-12
• Study Start: 2017-08-15
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-06
• Last Update Posted: 2017-10-09
• Primary Completion: 2018-06-01
• Study Completion: 2018-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot assisted thoracic surgery	Video assited thoracic surgery	RATS
Video assisted thoracic surgery	Robot assited thoracic surgery	VATS

Primary Outcome Measures

Name	Time	Method
Postoperative pain	2 months	0 = no pain 10 = unbearable pain: VASscore

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Brussel, Belgium