Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421974
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-03
Brief Title:
Effectiveness of Robotic Surgery for Right Colon Cancer
Sponsor:
Sir Run Run Shaw Hospital
Organization:
Sir Run Run Shaw Hospital
Study Overview
Official Title:
A Prospective Multicenter Randomized Controlled Trial of the Effectiveness of Robotic Versus Laparoscopic Surgery for Right Colon Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
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:
This study aims to explore through a multi-center randomized controlled clinical study whether robot-assisted radical resection of right colon cancer is superior to laparoscopic surgery in terms of surgical quality and oncological prognosis
Detailed Description:
The incidence rate of colorectal cancer has risen to the second place in my country highlighting its significant impact on public health It is a high-incidence malignant tumor that seriously threatens the health of our people Surgery is the core treatment method for curing colorectal cancer With the promotion of multidisciplinary comprehensive treatment models in-depth understanding of abdominal and pelvic anatomy and innovations in surgical instruments and techniques colorectal cancer surgery is gradually developing in the direction of minimally invasive and organ function preservation This advancement not only improves the safety and effectiveness of surgery but also improves patients postoperative quality of life Laparoscopic surgery has obvious minimally invasive advantages in the treatment of right colon cancer Compared with traditional laparotomy laparoscopic surgery has the advantages of less trauma less postoperative pain faster recovery and shorter hospital stay
Since Hohenberger proposed the concept of complete mesocolic excision CME the principle of CME has become a key technique in colon cancer surgery which emphasizes thorough lymph node dissection and precise tumor resection In radical resection of right colon cancer CME technology ensures complete resection of surrounding tissue by performing surgery along the natural anatomical plane of blood vessels and nerve plexuses thereby reducing the local recurrence rate of the tumor A retrospective cohort study of 1395 cases included in the Danish Colorectal Cancer Study Group showed that the 4-year disease-free survival rate of patients of all stages after CME surgery was 858 95 CI 814-901 and that after non-CME surgery the 4-year disease-free survival rate was 858 95 CI 814-901 The 4-year disease-free survival rate was 759 95 CI 722-797 log-rank p00010 which preliminarily proved that the CME principle can significantly improve the disease recurrence-free survival DFS rate This method aims to achieve better tumor cure results through more extensive and complete resection
However with the continuous innovation of surgical instruments and technologies laparoscopic surgery is also facing some challenges Laparoscopic surgery often provides a two-dimensional field of view which may limit the surgeons depth perception and accuracy when performing complex procedures In addition the operating rods of traditional laparoscopic tools are relatively long and the operating space is limited which may lead to difficulties in gesture amplification and fine motor control during surgery resulting in certain defects in surgical operation accuracy and visual field stability
The robot-assisted surgical system provides a new technical platform for improving the quality of surgical operations with its enhanced visual capabilities stable field of view and flexibility of surgical instruments The stability of the three-dimensional stereo vision system and camera platform can significantly improve the surgical field of view while the high flexibility of the robotic arm optimizes surgical operations Existing clinical studies show that compared with traditional laparoscopic surgery robot-assisted surgical systems have potential advantages in reducing the proportion of conversions to laparotomy reducing the occurrence of postoperative complications and shortening postoperative recovery time
When considering the economic burden of robotic-assisted surgical systems relative to conventional laparoscopic surgery more rigorous and quantitative evidence is necessary to assess their economic benefits in daily clinical practice Although robot-assisted surgical systems offer operational advantages their high equipment investment and maintenance costs remain a major obstacle to their adoption Therefore a comprehensive cost-effectiveness analysis combined with an assessment of surgical outcomes patient recovery and long-term health-related quality is critical to determine its suitability in the healthcare system The REAL randomized controlled study led by Professor Xu Jianmin compared the surgical quality and long-term tumor prognosis of robot-assisted surgery and conventional laparoscopic surgery in patients with middle and low rectal cancer The primary endpoint of the study was the 3-year local recurrence rate while the secondary endpoints focused on the positive circumferential margin rate and the 30-day postoperative complication rate The short-term secondary endpoint data that have been published so far are encouraging However there is still a lack of multicenter randomized controlled clinical studies on the long-term oncological outcomes of robotic surgery for right colon cancer
This study aims to compare the 3-year disease recurrence-free survival DFS between robot-assisted radical right hemicolectomy RA-LSRHC and conventional laparoscopic radical right hemicolectomy LSRHC through a multicenter randomized controlled study The non-inferiority in terms of surgery provides high-quality evidence-based medical evidence for robot-assisted right colon cancer surgery further optimizes treatment strategies and improves patients quality of life
Since Hohenberger proposed the concept of complete mesocolic excision CME the principle of CME has become a key technique in colon cancer surgery which emphasizes thorough lymph node dissection and precise tumor resection In radical resection of right colon cancer CME technology ensures complete resection of surrounding tissue by performing surgery along the natural anatomical plane of blood vessels and nerve plexuses thereby reducing the local recurrence rate of the tumor A retrospective cohort study of 1395 cases included in the Danish Colorectal Cancer Study Group showed that the 4-year disease-free survival rate of patients of all stages after CME surgery was 858 95 CI 814-901 and that after non-CME surgery the 4-year disease-free survival rate was 858 95 CI 814-901 The 4-year disease-free survival rate was 759 95 CI 722-797 log-rank p00010 which preliminarily proved that the CME principle can significantly improve the disease recurrence-free survival DFS rate This method aims to achieve better tumor cure results through more extensive and complete resection
However with the continuous innovation of surgical instruments and technologies laparoscopic surgery is also facing some challenges Laparoscopic surgery often provides a two-dimensional field of view which may limit the surgeons depth perception and accuracy when performing complex procedures In addition the operating rods of traditional laparoscopic tools are relatively long and the operating space is limited which may lead to difficulties in gesture amplification and fine motor control during surgery resulting in certain defects in surgical operation accuracy and visual field stability
The robot-assisted surgical system provides a new technical platform for improving the quality of surgical operations with its enhanced visual capabilities stable field of view and flexibility of surgical instruments The stability of the three-dimensional stereo vision system and camera platform can significantly improve the surgical field of view while the high flexibility of the robotic arm optimizes surgical operations Existing clinical studies show that compared with traditional laparoscopic surgery robot-assisted surgical systems have potential advantages in reducing the proportion of conversions to laparotomy reducing the occurrence of postoperative complications and shortening postoperative recovery time
When considering the economic burden of robotic-assisted surgical systems relative to conventional laparoscopic surgery more rigorous and quantitative evidence is necessary to assess their economic benefits in daily clinical practice Although robot-assisted surgical systems offer operational advantages their high equipment investment and maintenance costs remain a major obstacle to their adoption Therefore a comprehensive cost-effectiveness analysis combined with an assessment of surgical outcomes patient recovery and long-term health-related quality is critical to determine its suitability in the healthcare system The REAL randomized controlled study led by Professor Xu Jianmin compared the surgical quality and long-term tumor prognosis of robot-assisted surgery and conventional laparoscopic surgery in patients with middle and low rectal cancer The primary endpoint of the study was the 3-year local recurrence rate while the secondary endpoints focused on the positive circumferential margin rate and the 30-day postoperative complication rate The short-term secondary endpoint data that have been published so far are encouraging However there is still a lack of multicenter randomized controlled clinical studies on the long-term oncological outcomes of robotic surgery for right colon cancer
This study aims to compare the 3-year disease recurrence-free survival DFS between robot-assisted radical right hemicolectomy RA-LSRHC and conventional laparoscopic radical right hemicolectomy LSRHC through a multicenter randomized controlled study The non-inferiority in terms of surgery provides high-quality evidence-based medical evidence for robot-assisted right colon cancer surgery further optimizes treatment strategies and improves patients quality of life
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