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

NCT00155727 | Unknown

• 1 other identifier: 9100017028
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Colorectal Cancer

Keywords

colorectal cancer, laparoscopic colectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cancer with distant metastasis, adjacent organ invasion, intestinal obstruction, past colonic surgery, and no consent to participate in the study.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Surgery, National Taiwan University Hospital, No.7, Chung-Shan South Road, Taipei, TAIWAN, R.O.C.

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• 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.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin-Tung Liang, M.D., Ph.D.

CONTACT

886-2-23562068; jintung@ha.mc.ntu.edu.tw

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 12, 2005
• Study Start: January 1, 2000
• Study Completion: July 1, 2005
• Last Updated: December 20, 2005

Record last verified: 2005-07

Locations

TW (1)