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

NCT03152071 — Not applicable, Unknown, 30 participants, Universitair Ziekenhuis Brussel

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

RegistryNCT03152071
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, other
Enrollment30 (Estimated)
SponsorUniversitair Ziekenhuis Brussel (Other)
ConditionsLung Cancer, Postoperative Pain, Blood Loss, Inflammatory Response
InterventionsRobot assited thoracic surgery, Video assited thoracic surgery (Procedure)
Datesstart 2017-08-15, primary completion 2018-06-01 (estimated), completion 2018-07-01 (estimated), first posted 2017-05-12, last updated 2017-10-09
Locations1 site in Belgium

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-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.

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+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).

+Arms and interventions

ArmTypeInterventionsDescription
Robot assisted thoracic surgeryExperimentalProcedure: Video assited thoracic surgeryRATS
Video assisted thoracic surgeryActive comparatorProcedure: Robot assited thoracic surgeryVATS
  • Robot assited thoracic surgery (Procedure), also known as RATS: 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 (Procedure), also known as VATS: The lobectomy will be preformed in case of an operable lung cancer. The thoracic surgery technique used is video assisted thoracic surgery.

+Outcome measures

Primary outcomes

  • Postoperative pain [2 months]: 0 = no pain 10 = unbearable pain: VASscore

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Universitair Ziekenhuis BrusselJette, Brussels CapitalBelgiumRecruiting

+Investigators

My Notes