Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00155727
Status:
UNKNOWN
Last Update Posted:
2005-12-20
First Post:
2005-09-09
Brief Title:
Comparison of Laparoscopic Colectomy Versus Open Colectomy for Colorectal Cancer A Prospective Randomized Trial
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Comparison of Treatment Outcome for Laparoscopic Colectomy Versus Traditional Open Colectomy for the Treatment of Colorectal Cancer A Prospective Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2005-07
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:
The laparoscopic colectomy has been enthusiastically used by many colorectal surgeons in Taiwan Japan Europe and USA for around 10 years Further clarification of the controversies cited above will be based on the evidence-based medicine ie the randomized well-controlled prospective clinical trials Actually a handful of randomized prospective data regarding the laparoscopic colectomy has been appeared in USA and Europe However we still do not have this kind of data in Taiwan and therefore this study is important and mandatory
In this project we assumed that a difference in cancer-related survival of less then 15 between treatments indicates an equivalent efficacy Assuming a 70 5-year cancer-related survival of stage II and III colorectal cancer patients in the open colectomy group a minimum of 100 patients per group was required to showed that both surgical techniques were equivalent with an α-level of 020 and a β error of 005 Only patients with stage II and III disease undergoing curative resection will be enrolled onto this study The patients will be randomly allocated to either treatment group by block randomization method Postoperatively the patients will be prospectively evaluated regarding the following parameters including operative stress such as erythrocyte sedimentation rate serum interleukin-6 WBC counts and classification CD-4 to CD-8 ratio postoperative life quality such as wound size degree of pain time to have flatus passage and feeding time to resume daily activity and work and the oncological outcomes such as recurrence patterns of tumor and 5-year patient survival The evaluation of above-mentioned parameters will be single-blindly done by our research assistant who has no idea of both surgical techniques We hope this study will promote the level of surgical research in Taiwan
In this project we assumed that a difference in cancer-related survival of less then 15 between treatments indicates an equivalent efficacy Assuming a 70 5-year cancer-related survival of stage II and III colorectal cancer patients in the open colectomy group a minimum of 100 patients per group was required to showed that both surgical techniques were equivalent with an α-level of 020 and a β error of 005 Only patients with stage II and III disease undergoing curative resection will be enrolled onto this study The patients will be randomly allocated to either treatment group by block randomization method Postoperatively the patients will be prospectively evaluated regarding the following parameters including operative stress such as erythrocyte sedimentation rate serum interleukin-6 WBC counts and classification CD-4 to CD-8 ratio postoperative life quality such as wound size degree of pain time to have flatus passage and feeding time to resume daily activity and work and the oncological outcomes such as recurrence patterns of tumor and 5-year patient survival The evaluation of above-mentioned parameters will be single-blindly done by our research assistant who has no idea of both surgical techniques We hope this study will promote the level of surgical research in Taiwan
Detailed Description:
The appropriateness of laparoscopic surgery for the resection of colorectal cancer has been the focus of controversy The pros insist that besides the smaller wound size laparoscopic colectomy should induce lesser perioperative stress which was evidenced by the less pain quicker flatus passage early feeding and more rapid to resume daily activity and work Moreover since the laparoscopic colectomy induces lesser immunosuppression this may be potentially positive for the treatment of colorectal cancer patients However the cons insist that first of all when the summation of 4 or 5 ports and incisional wound to retrieve specimen in laparoscopic colectomy were considered the total wound size in laparoscopic colectomy is basically similar to that of the open colectomy Secondly since the laparoscopic surgeons advocated that the extent of intra-abdominal dissection was the same between laparoscopic and open colectomy it seems illogical to speculate that laparoscopic procedure is less invasive for the colorectal cancer patients than the open procedure Moreover in regard of the short-term improvement of life quality based on the evaluation of parameters including less painful quicker to have flatus passage feeding to resume daily activity to return to work etc there is no denying that these potential benefits are at the sacrifice of spending more money and therefore it is still unknown if laparoscopic colectomy is cost-effective Thirdly and most important of all laparoscopic colectomy is a more difficult for most surgeons and therefore the learning curve is more difficult to overcome Moreover many surgeons concerned if pneumoperitoneum during the laparoscopic procedure will reinforce the intraperitoneal spread of colorectal cancer Based on above-mentioned reasons many colorectal surgeons hesisted between the lines of safety and efficacy of laparoscopic colectomy
However apparently the laparoscopic colectomy has been enthusiastically used by many colorectal surgeons in Taiwan Japan Europe and USA for around 10 years Further clarification of the controversies cited above will be based on the evidence-based medicine ie the randomized well-controlled prospective clinical trials Actually a handful of randomized prospective data regarding the laparoscopic colectomy has been appeared in USA and Europe However we still do not have this kind of data in Taiwan and therefore this study is important and mandatory
In this project we assumed that a difference in cancer-related survival of less then 15 between treatments indicates an equivalent efficacy Assuming a 70 5-year cancer-related survival of stage II and III colorectal cancer patients in the open colectomy group a minimum of 100 patients per group was required to showed that both surgical techniques were equivalent with an α-level of 020 and a β error of 005 Only patients with stage II and III disease undergoing curative resection will be enrolled onto this study The patients will be randomly allocated to either treatment group by block randomization method Postoperatively the patients will be prospectively evaluated regarding the following parameters including operative stress such as erythrocyte sedimentation rate serum interleukin-6 WBC counts and classification CD-4 to CD-8 ratio postoperative life quality such as wound size degree of pain time to have flatus passage and feeding time to resume daily activity and work and the oncological outcomes such as recurrence patterns of tumor and 5-year patient survival The evaluation of above-mentioned parameters will be single-blindly done by our research assistant who has no idea of both surgical techniques We hope this study will promote the level of surgical research in Taiwan
However apparently the laparoscopic colectomy has been enthusiastically used by many colorectal surgeons in Taiwan Japan Europe and USA for around 10 years Further clarification of the controversies cited above will be based on the evidence-based medicine ie the randomized well-controlled prospective clinical trials Actually a handful of randomized prospective data regarding the laparoscopic colectomy has been appeared in USA and Europe However we still do not have this kind of data in Taiwan and therefore this study is important and mandatory
In this project we assumed that a difference in cancer-related survival of less then 15 between treatments indicates an equivalent efficacy Assuming a 70 5-year cancer-related survival of stage II and III colorectal cancer patients in the open colectomy group a minimum of 100 patients per group was required to showed that both surgical techniques were equivalent with an α-level of 020 and a β error of 005 Only patients with stage II and III disease undergoing curative resection will be enrolled onto this study The patients will be randomly allocated to either treatment group by block randomization method Postoperatively the patients will be prospectively evaluated regarding the following parameters including operative stress such as erythrocyte sedimentation rate serum interleukin-6 WBC counts and classification CD-4 to CD-8 ratio postoperative life quality such as wound size degree of pain time to have flatus passage and feeding time to resume daily activity and work and the oncological outcomes such as recurrence patterns of tumor and 5-year patient survival The evaluation of above-mentioned parameters will be single-blindly done by our research assistant who has no idea of both surgical techniques We hope this study will promote the level of surgical research in Taiwan
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None