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

NCT ID: NCT03152071

Last Updated: 2017-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-15

Study Completion Date

2018-07-01

Brief Summary

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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

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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).

Conditions

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Lung Cancer Postoperative Pain Blood Loss Inflammatory Response

Keywords

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thoracoscopic surgery RATS VATS Robot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Robot assisted thoracic surgery

RATS

Group Type EXPERIMENTAL

Video assited thoracic surgery

Intervention Type PROCEDURE

The lobectomy will be preformed in case of an operable lung cancer. The thoracic surgery technique used is video assisted thoracic surgery.

Video assisted thoracic surgery

VATS

Group Type ACTIVE_COMPARATOR

Robot assited thoracic surgery

Intervention Type PROCEDURE

The lobectomy will be preformed in case of an operable lung cancer. The thoracic surgery technique used is robot assisted thoracic surgery

Interventions

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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

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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RATS VATS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Veerle Van Mossevelde

data nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wietske Renckens, MD

Role: STUDY_CHAIR

Universitair Ziekenhuis Brussel

Dirk Smets, MD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Eef Vanderhelst, MD

Role: STUDY_DIRECTOR

Universitair Ziekenhuis Brussel

Locations

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Universitair Ziekenhuis Brussel

Jette, Brussels Capital, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Veerle Van Mossevelde, data nurse

Role: CONTACT

Phone: +3224763134

Email: [email protected]

Dirk De Clippeleir, data nurse

Role: CONTACT

Phone: +3224763580

Email: [email protected]

Facility Contacts

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Dirk Smets, MD

Role: primary

Wietske Renckens, meMD

Role: backup

Other Identifiers

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RATS vs VATS

Identifier Type: -

Identifier Source: org_study_id