Robotic, Laparoscopic and Open Surgery for Gastric Cancer Compared on Surgical, Clinical and Oncological Outcomes
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|ClinicalTrials.gov Identifier: NCT02325453|
Recruitment Status : Recruiting
First Posted : December 25, 2014
Last Update Posted : April 22, 2019
Gastric cancer represents a great challenge for health care providers and requires a multidisciplinary context in which surgery plays a main role.
Minimally invasive surgery has been progressively developed, first with the advent of laparoscopy and more recently with the spread of robotic systems, but a number of issues are currently being debated, including the limitations in performing effective extended lymph node dissections and, in this context, the real advantages of using the robotic systems, the possible role for the Advanced Gastric Cancer, the reproducibility of completely intracorporeal techniques and the oncological results achievable during follow-up.
A multicenter study with a large number of patients is now needed to further investigate the safety and efficacy as well as long-term outcomes of robotic surgery, traditional laparoscopy and the open approach.
|Condition or disease||Intervention/treatment|
|Gastric Cancer||Procedure: Robotic Surgery Procedure: Laparoscopic Surgery Procedure: Open Surgery|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||7000 participants|
|Official Title:||A Multi-Institutional Chart Review to Compare the Outcomes of Robotic, Laparoscopic and Open Surgery for Gastric Cancer.|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Patients underwent gastric surgery through the use of a robotic system.
Procedure: Robotic Surgery
Surgical procedure performed with a robotic system.
Patients underwent gastric surgery with laparoscopic procedures.
Procedure: Laparoscopic Surgery
Surgical procedure performed with laparoscopic techniques.
Patients underwent gastric surgery with open approach.
Procedure: Open Surgery
Traditional approach for gastric cancer.
- Compare robotic and laparoscopic surgery with the open approach in terms of safety and feasibility. (Intraoperative complications.) [ Time Frame: Intraoperative. ]Intraoperative complications.
- Verify the respect of oncological principles through minimally invasive approaches in relation to the stage and location of the tumor by comparing results with open surgery. (Number of lymph nodes retrieved.) [ Time Frame: Intraoperative. ]Number of lymph nodes retrieved.
- Compare the three treatment arms in terms of recovery of gastrointestinal functions and physical status allowing the discharge of the patient. (Days of hospitalization after surgery until discharge.) [ Time Frame: Assessment during an average period of 10 days after surgery. ]Days of hospitalization after surgery until discharge.
- Compare the incidence, types and severity of early postoperative complications after gastrectomy by the three approaches. (Score based on the Clavien-Dindo classification system.) [ Time Frame: Assessment during an average period of 10 days after surgery. ]Score based on the Clavien-Dindo classification system.
- Verify whether minimally invasive approaches ensure the same effectiveness than open surgery. (Overall survival.) [ Time Frame: Assessment at 1, 3, 5 years from surgery. ]Overall survival.
- Compare the three treatment arms in terms of tumor recurrence after treatment. (Disease-free survival) [ Time Frame: Assessment at 1, 3, 5 years from surgery. ]Disease-free survival.
- Verify the safety of intracorporeal anastomosis in comparison with extracorporeal anastomosis. (Anastomotic leakage) [ Time Frame: Assessment during an average period of 10 days after surgery. ]Anastomotic leakage.
- Compare the intracorporeal anastomosis with the extracorporeal anastomosis to evaluate post-operative recovery. (Days of hospitalization after surgery until discharge.) [ Time Frame: Assessment during an average period of 10 days after surgery. ]Days of hospitalization after surgery until discharge.
- Verify whether robotic gastrectomy, compared with laparoscopic or open techniques, is capable of improving postoperative surgical stress. (Granulocyte-to-lymphocyte ratio.) [ Time Frame: Assessment during an average period of 10 days after surgery. ]Granulocyte-to-lymphocyte ratio.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02325453
|Contact: Jacopo Desiderio, MDfirstname.lastname@example.org|
|Contact: Amilcare Parisi, MDemail@example.com|
|Department of Digestive Surgery, St. Mary's Hospital, University of Perugia||Recruiting|
|Terni, Italy, 05100|
|Contact: Amilcare Parisi firstname.lastname@example.org|
|Contact: Jacopo Desiderio email@example.com|
|Principal Investigator:||Amilcare Parisi, MD||Azienda Ospedaliera S. Maria di Terni|