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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03152071
• Other study ID #: RATS vs VATS
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2017
• Last updated: October 6, 2017
• Start date: August 15, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: October 2017
• Source: Universitair Ziekenhuis Brussel
• Contact: Veerle Van Mossevelde, data nurse
• Phone: +3224763134
• Email: veerle.vanmossevelde[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss
• Inflammatory Response
• Lung Cancer
• Lung Neoplasms
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Robot assited thoracic surgery
The lobectomy will be preformed in case of an operable lung cancer. The thoracic surgery technique used is robot assisted thoracic surgery
• Video assited thoracic surgery
The lobectomy will be preformed in case of an operable lung cancer. The thoracic surgery technique used is video assisted thoracic surgery.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	0 = no pain 10 = unbearable pain: VASscore	2 months
Secondary	blood loss	ml	up to 4 hours
Secondary	operative time	duration of surgery	up to 4 hours
Secondary	conversion to spreading of the ribs/thoracotomy	0 = no 1 = yes	up to 4 hours
Secondary	lymph node dissection	number of lymph nodes	up to 4 hours
Secondary	prolonged air leak	chest tube present longer than usual	up to 7 days
Secondary	chest tube drainage	ml	up to 7 days
Secondary	length of stay	duration of hospitalisation after surgery	up to 7 days
Secondary	pulmonary function	recovery of function of the operated lung	2 months
Secondary	Inflammatory reaction	these inflammatory parameters will be determined: C-reactive protein; IL-3; IL-6; TNF	48 hours