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

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

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain; Inflammatory Response; Lung Cancer; Blood Loss
• Intervention / Treatment: Procedure: Video assited thoracic surgery; Procedure: Robot assited thoracic surgery

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Veerle Van Mossevelde, Data Nurse; Phone Number: +3224763134; Email: veerle.vanmossevelde@uzbrussel.be
• Study Contact Backup: Name: Dirk De Clippeleir, data nurse; Phone Number: +3224763580; Email: dirk.declippeleir@uzbrussel.be

Study Locations

• Belgium
  • Brussel
    • Jette, Brussel, Belgium, 1090
      • Recruiting
      • Universitair Ziekenhuis Brussel
      • Contact: Dirk Smets, MD; Email: dirk.smets@uzbrussel.be
      • Contact: Wietske Renckens, meMD; Email: wietske.renckens@vub.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot assisted thoracic surgery; RATS	Procedure: 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.; Other Names: VATS
Active Comparator: Video assisted thoracic surgery; VATS	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; Other Names: RATS

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Study Chair: Wietske Renckens, MD, Universitair Ziekenhuis Brussel; Principal Investigator: Dirk Smets, MD, Universitair Ziekenhuis Brussel; Study Director: Eef Vanderhelst, MD, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): October 9, 2017
• Last Update Submitted That Met QC Criteria: October 6, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: thoracoscopic surgery; RATS; VATS; Robot
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: RATS vs VATS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No