Comparison of Laparoscopic Colectomy Versus Open Colectomy for Colorectal Cancer: … A Prospective Randomized Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00155727
First received: September 9, 2005
Last updated: December 19, 2005
Last verified: July 2005
  Purpose

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, i.e., 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 0.20 and a β error of 0.05. 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.


Condition Phase
Colorectal Cancer
Phase 3

Study Type: Observational
Study Design: Allocation: Random Sample
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Comparison of Treatment Outcome for Laparoscopic Colectomy Versus Traditional Open Colectomy for the Treatment of Colorectal Cancer: … A Prospective Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 600
Study Start Date: January 2000
Estimated Study Completion Date: July 2005
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, i.e., 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 0.20 and a β error of 0.05. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All consecutive patients admitted to our unit since January 2000 with adenocarcinoma of the colon and rectum will be assessed.

Exclusion Criteria:

  • Cancer with distant metastasis, adjacent organ invasion, intestinal obstruction, past colonic surgery, and no consent to participate in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00155727

Contacts
Contact: Jin-Tung Liang, M.D., Ph.D. 886-2-23562068 jintung@ha.mc.ntu.edu.tw

Locations
Taiwan
Department of Surgery, National Taiwan University Hospital, No.7, Chung-Shan South Road, Taipei, TAIWAN, R.O.C. Recruiting
Taipei, Taiwan, 100
Contact: Jin-Tung Liang, M.D., Ph.D.    886-2-23562068    jintung@ha.mc.ntu.edu.tw   
Principal Investigator: Jin-Tung Liang, M.D., Ph.D.         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jin-Tung Liang, M.D., Ph.D. Department of Surgery, National Taiwan University Hospital, No.7, Chung-Shan South Road, Taipei, TAIWAN, R.O.C.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00155727     History of Changes
Other Study ID Numbers: 9100017028
Study First Received: September 9, 2005
Last Updated: December 19, 2005
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
colorectal cancer, laparoscopic colectomy

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 22, 2014