An observational study in Early Stage Lung Cancer (I and II) and Non-Small Cell Lung Cancer, sponsored by Scientific Institute San Raffaele. Recruiting at 4 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-17.
Sponsored by Scientific Institute San Raffaele · Observational
The study is a retrospective, observational and multicentric study. The study describes robotic segmentectomies performed in four referred centers, with the aim to assess the perioperative compilications of robotic segmentectomies compared to video-assisted thoracoscopic surgery (VATS) and open approach.
Minimally invasive techniques have been gradually replacing open approach in the treatment of lung cancer. Video-assisted thoracoscopic surgery (VATS) was the first procedure to be developed in the thoracic field and is the most widespread. It has been associated with decreased postoperative pain, shorter recovery, decreased inflammatory response and improved tolerance to chemotherapy.
What is limiting video-assisted thoracoscopic surgery (VATS) spread is the steep learning curve, difficulties and discomfort to operate, suboptimal view and rigid instrumentation. These problems have been partially overcome by the Robotic technique (RATS).
This study aims to compare the perioperative complications of robotic segmentectomies to VATS and open approaches.
In addition, The secondary aim of the study is to analyze the duration of surgery, mediastinal and hilar lymph nodes dissection, rate of conversion of robotic approach compared to VATS, overall survival and disease free survival in the three different approaches.
The study is retrospective, observational and multicentric. The four centers involved are: IRCCS San Raffaele Hospital, IRCCS European Institute of Oncology - IEO, IRCCS Humanitas Research Hospital - ICH and the department of General Thoracic Surgery, Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
The population includes: all patients that underwent segmentectomies from the 1st January 2010 to the 31st of December 2023 treated with robotic segmentectomy and VATS or open segmentectomy, reaching a total of 472 cases of which 50 from our hospital.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 472 is above the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Scientific Institute San Raffaele is the lead sponsor of 29 studies on the registry; 12 are open to participants now.
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Patients that underwent segmentectomies from the 1st January 2010 to the 31st of December 2023 treated with robotic segmentectomy (case) and video-assisted thoracoscopic (VATS) or open segmentectomy (control)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with a pre or post-operative diagnosis of NSCLC surgically treated with robotic segmentectomy from 1st January 2010 to the 31st to December 2023
Patients with a pre or post-operative diagnosis of NSCLC surgically treated with video-assisted thoracoscopic surgery (VATS) and open segmentectomy from 1st January 2010 to the 31st to December 2023
The perioperative complications of robotic approach
The investigators will measure the perioperative complications of robotic lung resection in patients with a pre or post-operative diagnosis of non-small cell lung cancer (NSCLC). Complications will be categorized according to the Clavien-Dindo scale.
Time frame: from the surgery at 30-90 days after
The perioperative complication of video-assisted thoracoscopic surgery (VATS) approach
The investigators will measure the perioperative complications of video-assisted thoracoscopic surgery (VATS) appraoch in patients with a pre or post-operative diagnosis of non-small cell lung cancer (NSCLC). Complications will be categorized according to the Clavien-Dindo scale.
Time frame: 30-90 days after surgery
The perioperative complications of the open approach
The investigators will measure the perioperative complications of open approach in patients with a pre or post-operative diagnosis of non-small cell lung cancer (NSCLC). Complications will be categorized according to the Clavien-Dindo scale.
Time frame: 30-90 days after surgery
Duration of surgery
Duration of the surgery based on the approach measured in minutes
Time frame: up to 1 month
Quality of lymphadenectomy
Number of lymphonodes station resected
Time frame: up to 1 month
Conversion rate
Number of surgery procedures converted
Time frame: up to 1 month
Survival analysis
Presence or absence of local and distant relapse
Time frame: up to 5 years
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Scientific Institute San Raffaele