Symptoms and General Pathology

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Behaviors and Mental Disorders

Pain, Postoperative

Lung Neoplasms

Pain

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Quality of Life

The aim of the study is to compare quality of life and early and late post-operative pain after anatomical lung resection (lobectomy or segmentectomy) performed by a robotic approach compared to the videothoracoscopic approach (VATS) and the thoracotomic approach antero-lateral in patients with early stage lung cancer.

Impact of Robotic Approach Compared to VATS and Open Approach on Quality of Life in Patients With Lung Cancer

Impact of Minimally Invasive Robotic Approach Compared to VATS and Open Approach on Quality of Life and Immune Response in Patients Candidated to Lobectomy or Anatomical Segmentectomy

The sample size is calculated on the primary end point which is the prospective evaluation of quality of life (QoL) evolution after robotic-assisted thoracoscopic resection versus videothoracoscopic resection versus

open thoracotomy, with the European Organisation for Research and Treatment of Cancer (EORTC) QoL Questionnaire-C30 and the lung cancer-specific module, LC-13.

51 patients operated in each group will provide 80% power to detect a 8-point difference in mean QLQ-C30 "Pain score" between any two study groups, at the 5% level of significance assuming a coefficient of variability of 0.5 and using a two-sided two-sample t-test. The scale parameters range are included from 1 (not at all) to 4 (very much).

Pain assessment will be recorded daily starting from the pre-operative day and post-operatively until discharge and subsequently at 2 weeks, 6 months and 12 months after surgery with numerical scale from 0 to 10 (ENV pain score); via questionnaire "Brief Pain Inventory".

A value of ENV ≤3 will be attributed to adequate analgesia; ENV a score of 4 to 6 will be considered inadequate analgesia with administration of analgesia as needed; ENV score ≥7 will be considered poor analgesia.

Conversion rate, defined as procedures that start with minimally invasive access and are converted to open surgery due to different reasons (bleeding, anatomical reasons, oncological reasons, technical reasons, other).

Surgical complications, higher or equal grade II assessed by Clavien-Dindo scale, within 90 days.

Disease free survival will be explored with survival analysis. The time will be calculated from the surgery data to the first recurrence date or to last contact date for all the patients free of disease at the end of surgery. Difference between groups will be explored with log-rank test.

Istituto Clinico Humanitas

for patients who received Da Vinci SP robotic surgery

To evaluate the performance and safety of the da Vinci SP® Surgical System in anatomical lung resection

Lung Anatomic Resection (Da Vinci SP)

Yin Kai Chao, MD,PHD

This is the first human clinical study for explore the feasibility of lung anatomic resection through Da Vinci SP surgical platform

During the past several years, minimally invasive thoracic surgery has evolved from thoracoscopic approaches using 3 -4 ports to a single incision video-assisted thoracoscopic surgery (VATS) techniques. Recently, the experience acquired with the uniportal VATS technique through the intercostal space has allowed the development of a uniportal VATS subxiphoid or subcostal approach for major pulmonary resections. The advantage of using a subxiphoid or subcostal entry is to reduce pain by avoiding possible trauma of intercostal nerves caused by thoracic incisions. However, the longer distance from the subxiphoid or subcostal incision to the hilum makes this approach more difficult to perform anatomical pulmonary resections.During this same period of evolution into uniportal VATS surgery, robotic thoracic surgery has gained popularity as an alternative to traditional VATS. The advantages of robotics are the ability to perform surgery more precisely with articulated or wristed instruments, motion scaling, and tremor filtration, as well as improved visualization thanks to 3D high-definition video. However, currently 4 -5 incisions are still necessary to perform anatomic robotic resections.Recently, there has been a convergence of these two trends-uniportal surgery and robotic-assisted surgery-and has resulted in a single port robotic system, the da Vinci SP by Intuitive Surgical Cooperation. For this new platform, investigators plan to practice in thoracic anatomic lung resection

clinical lung cancer who receive Da Vinci sp robotic surgery

Single Port Robotic Lung Anatomical Resection

Pilot Study of Single Port Robotic Surgery for Anatomical Lung Resection

Enrolled subjects would be assessed by pain scale score at baseline (preoperatively), during inpatient phase.

Neuropathic pain assessment (Assessment of post-VATS surgery neuralgia- pain DETECT Questionnaire), performed during inpatient phase (Post-operation 1 day, 2 days and day of discharge) and 1 week, 1,3,6,12 months after discharge.

Enrolled subjects would be assessed by numbness score at baseline (preoperatively), during inpatient phase.

Neuropathic pain assessment (Assessment of post-VATS surgery neuralgia- pain DETECT Questionnaire), performed during inpatient phase (Post-operation 1 day, 2 days and day of discharge) and 1 week, 1,3,6,12 months after discharge.

pathologic tumor staging, surgical margins

Unplanned procedure-related reoperations or readmissions, mortality

The primary performance endpoint will be assessed as the ability to successfully complete the planned anatomic resection procedure with the da Vinci SP System, with no conversion to thoracoscopic, multi-port robotic, or open surgery. Usage of additional assistant port(s) is not considered a conversion.

The primary safety endpoint will be assessed as the incidence of all intra-operative and post-operative adverse events that occur within the study follow-up period. Complications are assessed using the Common Terminology Criteria for Adverse Events, CTCAE.

Operation time (minute), docking time (minute), console time(minute), anesthesia time(minute), Time from recovery room to ward (minute)

which include bloods loss(ml) during operation, blood transfusion (ml) during surgery

which include, length of hospital stay (day)

which include in-hospital mortality and morbidity, reasons need for reoperation, unplanned procedure after surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of Robotic Approach Compared to VATS and Open Approach on Quality of Life in Patients With Lung Cancer	NCT04353349	Lung Cancer Robotic Thoraci... Video-assisted ... Open Thoracotom...		-	Istituto Clinico Humanitas
Impact of Robotic Approach Compared to VATS and Open Approach on Quality of Life in Patients With Lung Cancer	NCT04353349	Lung Cancer Robotic Thoraci... Video-assisted ... Open Thoracotom...		-	Istituto Clinico Humanitas
Single Port Robotic Lung Anatomical Resection	NCT05535712	Robotic Surgica...	Lung Anatomic R...	20 Years - 75 Years	Chang Gung Memorial Hospital

Spots Global Cancer Trial Database for robotic thoracic surgery