Ignite Creation Date:
2024-05-06 @ 10:57 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03396354
Status:
UNKNOWN
Last Update Posted:
2020-09-29
First Post:
2018-01-04
Brief Title:
Prospective Comparison of Surgical Outcomes With Using Integrated Robotic Technology Versus Conventional Laparoscopy for Gastric Cancer Surgery
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
Prospective Comparison of Surgical Outcomes With Using Integrated Robotic Technology Versus Conventional Laparoscopy for Gastric Cancer Surgery
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Despite the theoretical superiority of robotic technology surgical outcomes following robotic surgery have shown little benefit over conventional laparoscopic surgery At present studies have evaluated the value of robotic technology in clinical practice including EndoWrist TilePro Firefly and Single-Site and have demonstrated the possibility of added clinical value specifically in regards to decreased postoperative pancreatic fistula usefulness as a multi-display education system visualization of lymphatic channels and implementation of reduced-port robotic gastrectomy However these technologies have only been applied independently and not in a well-organized manner
Maximizing radicality and safety while minimizing invasiveness are critical to bettering cancer surgery We hypothesize that robot technology can affect these factors positively and that the use of appropriate parameters thereof could help shed more light on the benefits of a robotic system in gastric cancer surgery
1 Radicality added benefit of Firefly for lymph node visualization Number of retrieved lymph nodes can be considered a surrogate marker of long-term survival In our proposed study we will focus on the number of retrieved lymph nodes as the primary outcome Additionally bleeding which is known to be associated with poor overall survival will be measured as a secondary outcome Three-year recurrence free survival and 5-year overall survival will be followed up
2 Safety benefit of Firefly in differentiating lymph nodes from other organs and benefit of a magnified view and EndoWrist Although robotic surgery reportedly shows less in-hospital and outpatient complication rates a higher number of enrolled patients is needed to statistically validate these results In the currently proposed study these would be secondary outcomes We have experienced the benefit of using fluorescence imaging to differentiate lymph node from biliary trees and pancreas parenchyma As a reflection thereof bleeding would be measured as parameter of unintended injury to a normal organ To evaluate injury to pancreas parenchyma and postoperative pancreatic fistula amylaselipase levels in serum and drainage fluid will be measured
3 Invasiveness value of Single-Site Serum CRP C reactive protein levels day 0 day 3 day 5 and 4 weeks after surgery and pain scores at 6 hr 12 hr 24 hr 48 hr and 72 hr after surgery will be measured to evaluate surgical trauma to the patients Satisfaction on the wound will be evaluated using Korean version of the body image scale at one month after surgery
Maximizing radicality and safety while minimizing invasiveness are critical to bettering cancer surgery We hypothesize that robot technology can affect these factors positively and that the use of appropriate parameters thereof could help shed more light on the benefits of a robotic system in gastric cancer surgery
1 Radicality added benefit of Firefly for lymph node visualization Number of retrieved lymph nodes can be considered a surrogate marker of long-term survival In our proposed study we will focus on the number of retrieved lymph nodes as the primary outcome Additionally bleeding which is known to be associated with poor overall survival will be measured as a secondary outcome Three-year recurrence free survival and 5-year overall survival will be followed up
2 Safety benefit of Firefly in differentiating lymph nodes from other organs and benefit of a magnified view and EndoWrist Although robotic surgery reportedly shows less in-hospital and outpatient complication rates a higher number of enrolled patients is needed to statistically validate these results In the currently proposed study these would be secondary outcomes We have experienced the benefit of using fluorescence imaging to differentiate lymph node from biliary trees and pancreas parenchyma As a reflection thereof bleeding would be measured as parameter of unintended injury to a normal organ To evaluate injury to pancreas parenchyma and postoperative pancreatic fistula amylaselipase levels in serum and drainage fluid will be measured
3 Invasiveness value of Single-Site Serum CRP C reactive protein levels day 0 day 3 day 5 and 4 weeks after surgery and pain scores at 6 hr 12 hr 24 hr 48 hr and 72 hr after surgery will be measured to evaluate surgical trauma to the patients Satisfaction on the wound will be evaluated using Korean version of the body image scale at one month after surgery
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None