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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03152071
Other study ID # RATS vs VATS
Secondary ID
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
Health authority
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

Study Design


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
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