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

Primary Purpose

Lung Cancer, Postoperative Pain, Blood Loss

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Robot assited thoracic surgery
Video assited thoracic surgery
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lung Cancer focused on measuring thoracoscopic surgery, RATS, VATS, Robot

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitair Ziekenhuis BrusselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robot assisted thoracic surgery

Video assisted thoracic surgery

Arm Description

RATS

VATS

Outcomes

Primary Outcome Measures

Postoperative pain
0 = no pain 10 = unbearable pain: VASscore

Secondary Outcome Measures

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

Full Information

First Posted
May 9, 2017
Last Updated
October 6, 2017
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT03152071
Brief Title
Comparison of Robot Assisted Thoracic Surgery With Video Assisted Thoracic Surgery in Case of Lung Cancer
Official Title
Comparison of Robot Assisted Thoracic Surgery With Video Assisted Thoracic Surgery in Case of Lung Cancer: a Prospective Trial With Control Group
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Anticipated)
Study Completion Date
July 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Postoperative Pain, Blood Loss, Inflammatory Response
Keywords
thoracoscopic surgery, RATS, VATS, Robot

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robot assisted thoracic surgery
Arm Type
Experimental
Arm Description
RATS
Arm Title
Video assisted thoracic surgery
Arm Type
Active Comparator
Arm Description
VATS
Intervention Type
Procedure
Intervention Name(s)
Robot assited thoracic surgery
Other Intervention Name(s)
RATS
Intervention Description
The lobectomy will be preformed in case of an operable lung cancer. The thoracic surgery technique used is robot assisted thoracic surgery
Intervention Type
Procedure
Intervention Name(s)
Video assited thoracic surgery
Other Intervention Name(s)
VATS
Intervention Description
The lobectomy will be preformed in case of an operable lung cancer. The thoracic surgery technique used is video assisted thoracic surgery.
Primary Outcome Measure Information:
Title
Postoperative pain
Description
0 = no pain 10 = unbearable pain: VASscore
Time Frame
2 months
Secondary Outcome Measure Information:
Title
blood loss
Description
ml
Time Frame
up to 4 hours
Title
operative time
Description
duration of surgery
Time Frame
up to 4 hours
Title
conversion to spreading of the ribs/thoracotomy
Description
0 = no 1 = yes
Time Frame
up to 4 hours
Title
lymph node dissection
Description
number of lymph nodes
Time Frame
up to 4 hours
Title
prolonged air leak
Description
chest tube present longer than usual
Time Frame
up to 7 days
Title
chest tube drainage
Description
ml
Time Frame
up to 7 days
Title
length of stay
Description
duration of hospitalisation after surgery
Time Frame
up to 7 days
Title
pulmonary function
Description
recovery of function of the operated lung
Time Frame
2 months
Title
Inflammatory reaction
Description
these inflammatory parameters will be determined: C-reactive protein; IL-3; IL-6; TNF
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veerle Van Mossevelde, data nurse
Phone
+3224763134
Email
veerle.vanmossevelde@uzbrussel.be
First Name & Middle Initial & Last Name or Official Title & Degree
Dirk De Clippeleir, data nurse
Phone
+3224763580
Email
dirk.declippeleir@uzbrussel.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wietske Renckens, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dirk Smets, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eef Vanderhelst, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Study Director
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Jette
State/Province
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dirk Smets, MD
Email
dirk.smets@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Wietske Renckens, meMD
Email
wietske.renckens@vub.be

12. IPD Sharing Statement

Plan to Share IPD
No

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

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