Status:
COMPLETED
A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer
Lead Sponsor:
Haruhiko Fukuda
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Colorectal Cancer
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate oncological outcome of patients for T3 and T4 colorectal cancer undergoing laparoscopic versus open surgery.
Detailed Description
The benefits of laparoscopic surgery (LAP) in comparison to open surgery (OPEN) have been suggested with respect to decreased morbidity, decreased pain, faster recovery, and shorter hospital stay.1-4 ...
Eligibility Criteria
Inclusion
- Histologically proven colorectal carcinoma
- Tumor located in the cecum, ascending colon, sigmoid colon, or rectosigmoid colon
- T3 or deeper lesion without involvement of other organs
- Without multiple lesion other than carcinoma in situ
- Cancer classified as N0-2 and M0, according to the TNM classification system
- Tumor size \< 8 cm
- No bowel obstruction
- Age 20 \< and \> 75 years
- Sufficient organ function
- No history of gastrointestinal surgery
- No history of chemotherapy or radiotherapy
- Provided written informed consent
Exclusion
- Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
- Severe pulmonary emphysema, interstitial pneumonitis, or ischemic heart disease
- Pregnant or lactating women
- Severe mental disease
- Continuous systemic steroid therapy
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
1050 Patients enrolled
Trial Details
Trial ID
NCT00147134
Start Date
November 1 2004
End Date
March 1 2014
Last Update
September 22 2016
Active Locations (26)
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1
Fujita Health University
Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi-ken, Japan, 470-1192
2
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577
3
Toho University Sakura Hospital
Sakura,Shimoshidu,564-1, Chiba, Japan, 285-8741
4
Jyuntendo Urayasu Hospital
Urayasu,Tomioka,2-1-1, Chiba, Japan, 279-0021