Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05961423
Status:
RECRUITING
Last Update Posted:
2023-08-01
First Post:
2023-07-09
Brief Title:
Robotic vs Laparoscopic D3-D4 Lymphadenectomy for Colorectal Cancer
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Robotic Versus Laparoscopic D3-D4 Lymphadenectomy for Patients With Advanced Colorectal Cancer A Randomized Prospective Clinical Trial for the Comparison of Oncologic and Functional Outcomes
Status:
RECRUITING
Status Verified Date:
2023-04
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:
Approximately one third of patients with colorectal cancer are diagnosed as locally advanced stage with metastasis to N3 - N4 lymph nodes requiring a D3 - D4 lymphadenectomy Our previous study has indicated that by laparoscopic approach the extended abdomino-iliac lymphadenectomy the so-called D3-D4 lymph node dissection could be performed with quick convalescence and similar oncologic efficacy for the treatment of advanced recto-sigmoid cancer with metastatic lesions over N3-N4 lymph nodes as compared with traditional open surgery In the present study the investigators will further compare the oncologic and functional outcomes of robotic versus laparoscopic approach in performing such challenging surgical procedures for patients with advanced colorectal cancer requiring a D3-D4 lymphadenectomy through a randomized prospective clinical trial
Detailed Description:
Approximately one third of patients with colorectal cancer are diagnosed as locally advanced stage with metastasis to N3 - N4 lymph nodes requiring a D3 - D4 lymphadenectomy Our previous study has indicated that by laparoscopic approach the extended abdomino-iliac lymphadenectomy the so-called D3-D4 lymph node dissection could be performed with quick convalescence and similar oncologic efficacy for the treatment of advanced recto-sigmoid cancer with metastatic lesions over N3-N4 lymph nodes as compared with traditional open surgery In the present study the investigators will further compare the oncologic and functional outcomes of robotic versus laparoscopic approach in performing such challenging surgical procedures for patients with advanced colorectal cancer requiring a D3-D4 lymphadenectomy through a randomized prospective clinical trial
In the upcoming three years 202041-2023331consecutive recto-sigmoid cancer patients with metastasis to para- aortic lymph node will be screened and randomized to patient groups undergoing either robotic or laparoscopic D3-D4 lymph node dissection The extent of D4 lymph node dissection includes extirpation of the extra-mesenteric lymphatic basin along bilateral common iliac arteries and veins inferior vena cava and abdominal aorta upward to the level just below the duodenal third portion and left renal vein besides the traditional mesenteric dissection of paracolic N1 lymph nodes intermediate N2 mesenteric lymph nodes and lymph nodes around the root of inferior mesenteric artery N3 The harvested lymph nodes were mapped and managed according to the Japanese guidelines The metrics of surgical outcomes included the number of harvested lymph nodes time to recurrence of cancer after surgery the length of operation time blood loss intra-operative and post-operative complications and wound size Functional recovery was evaluated by length of post-operative flatus passage the restoration of urinary function hospitalization and degree of post-operative pain A subjective-response standardized questionnaire was given to patients to assess disability which included the number of days until return to partial activity full activity and work
Since the current randomized prospective study in this field is still lack of the investigators believe that this study will be of academic importance And clinically the presented study can to help set up the standard operation procedures for such patient and provide the level one evidence for National Health Insurance Administration in evaluating the reimbursement of HTA high technology assessment procedures
In the upcoming three years 202041-2023331consecutive recto-sigmoid cancer patients with metastasis to para- aortic lymph node will be screened and randomized to patient groups undergoing either robotic or laparoscopic D3-D4 lymph node dissection The extent of D4 lymph node dissection includes extirpation of the extra-mesenteric lymphatic basin along bilateral common iliac arteries and veins inferior vena cava and abdominal aorta upward to the level just below the duodenal third portion and left renal vein besides the traditional mesenteric dissection of paracolic N1 lymph nodes intermediate N2 mesenteric lymph nodes and lymph nodes around the root of inferior mesenteric artery N3 The harvested lymph nodes were mapped and managed according to the Japanese guidelines The metrics of surgical outcomes included the number of harvested lymph nodes time to recurrence of cancer after surgery the length of operation time blood loss intra-operative and post-operative complications and wound size Functional recovery was evaluated by length of post-operative flatus passage the restoration of urinary function hospitalization and degree of post-operative pain A subjective-response standardized questionnaire was given to patients to assess disability which included the number of days until return to partial activity full activity and work
Since the current randomized prospective study in this field is still lack of the investigators believe that this study will be of academic importance And clinically the presented study can to help set up the standard operation procedures for such patient and provide the level one evidence for National Health Insurance Administration in evaluating the reimbursement of HTA high technology assessment procedures
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