Symptoms and General Pathology

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Hemorrhage

Pain, Postoperative

Lung Neoplasms

Pain

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

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

Robot 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.

Video assited thoracic surgery

Veerle Van Mossevelde, data nurse

Dirk De Clippeleir, data nurse

Dirk Smets, MD

Wietske Renckens, meMD

Wietske Renckens, MD

Eef Vanderhelst, MD

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.

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).

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

0 = no pain 10 = unbearable pain: VASscore

duration of hospitalisation after surgery

recovery of function of the operated lung

these inflammatory parameters will be determined: C-reactive protein; IL-3; IL-6; TNF

Universitair Ziekenhuis Brussel

data nurse

VATS

RATS

Giulia Veronesi, MD

Elisa Dieci, PhD

Marco Alloisio, MD

Alberto Testori, MD

This is a prospective, randomized, multicenter study on 300 patients (150 VATS lobectomies and 150 robotic lobectomies) affected by early stage (I-II) lung cancer. The expected recruitment is one year and two year follow up. Surgeons should have a minimum of 30 major lung resections performed using one of the two techniques for participation in the study. Each participating centers should have the possibility to offer both techniques (Robotics and Vats). The primary end point is a combination of conversion and complication rate. The presence of at least one of the two events is considered a failure. Considering the rate of failure of 35% in the VATS arm, we want to see a failure rate not over 20% in the robot arm, so with a power of 80% and an alpha error of 5%, we need a total of 300 patients.

Videothoracoscopic (VATS) vs. Robotic Approach for Lobectomy or Anatomical Segmentectomy

Prospective, Randomized, Multicentric Study On Videothoracoscopic (Vats) Vs Robotic Approach For Lobectomy Or Anatomical Segmentectomy In Patients Affected By Early Lung Cancer (ROMAN)

Fondazione Umberto Veronesi

Istituto Clinico Humanitas

Before minimally invasive lung segmentectomy, preoperative chest CT scans are processed and evaluated with multi-plane (2D) reconstructions, according to the usual center protocol.

Before minimally invasive lung segmentectomy, preoperative chest CT scans are processed and evaluated with volume rendering (3D) reconstructions.

Before performing the surgery, patient performs a chest CT scan with contrast medium and standard two-dimensional (2D) reconstructions are performed to study the lesion, the anatomy of the bronchi and the pulmonary venous and arterial vessels.

CT scans 2D Reconstruction

Before performing the surgery, patient performs a chest CT scan with contrast medium and standard two-dimensional (2D) reconstructions plus a 3D reconstruction are performed to study the lesion, the anatomy of the bronchi and the pulmonary venous and arterial vessels.

CT scans 2D plus 3D Reconstruction

ZARACA Zaraca

Marco Damiano Pipitone

ZARACA FRANCESCO

With this project we want to study the effectiveness of 3D reconstruction of preoperative CT to reduce operating times, blood loss and conversions after segmentectomy performed in thoracoscopy / robotics.

Pulmonary segmentectomy is the surgery of first choice in malignant lung tumors with a diameter \<2 cm in diameter. Patients who are candidates for this type of treatment perform usually a preoperative CT scan with two-dimensional reconstructions (2D: axial, coronary and sagittal). Today it is possible to perform a preoperative three-dimensional reconstruction (3D: volume rendering) of the vessels and bronchi using special software.

Objectives of the study is to analyze, in these patients, the benefits of 3D reconstruction of vessels and bronchi compared to 2D reconstruction, analyzing intra- and post-operative data.The study aims to randomize 288 patients over 36 months.

Study design: Prospective, randomized, controlled study. In 50% of patients the preoperative study of anatomical structures will be performed with the standard 2D method, in the remaining 50% with a 2D and 3D reconstruction. The assignment will take place through access to an online feature on the study website.

Evaluations and statistical methods The statistical analysis will be carried out using parametric and nonparametric descriptive, inferential statistical methods, while the main outcome will be carried out using the analysis of variance (ANOVA) and covariance (ANCOVA) techniques.

Ethical aspects. The study will be conducted in accordance with applicable current legislation. Approval by all relevant ethics committees will be required. Each patient will provide a written consent to participate in the study, after being properly informed.

A prospective multicenter randomized study

Prospective rAndomized sTudy efficaCy tHree-dimensional rEconstructions Segmentectomy

Prospective Randomized Study on the Efficacy of Three-dimensional Reconstructions of Bronchial and Vascular Structures on Preoperative Chest CT Scan in Patients Who Are Candidates for Pulmonary Segmentectomy Surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Robot Assisted Thoracic Surgery With Video Assisted Thoracic Surgery in Case of Lung Cancer	NCT03152071	Lung Cancer Postoperative P... Blood Loss Inflammatory Re...	Robot assited t... Video assited t...	18 Years -	Universitair Ziekenhuis Brussel
Comparison of Robot Assisted Thoracic Surgery With Video Assisted Thoracic Surgery in Case of Lung Cancer	NCT03152071	Lung Cancer Postoperative P... Blood Loss Inflammatory Re...	Robot assited t... Video assited t...	18 Years -	Universitair Ziekenhuis Brussel
Videothoracoscopic (VATS) vs. Robotic Approach for Lobectomy or Anatomical Segmentectomy	NCT02804893	Lung Cancer	VATS RATS	18 Years -	Istituto Clinico Humanitas
Prospective rAndomized sTudy efficaCy tHree-dimensional rEconstructions Segmentectomy	NCT05716815	Lung Cancer Lung; Node	CT scans 2D Rec... CT scans 2D plu...	18 Years -	Ospedale Centrale Bolzano

Spots Global Cancer Trial Database for rats

Every month we try and update this database with for rats cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rats

Every month we try and update this database with for rats cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rats cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.