A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00147134
- Lead Sponsor
- Haruhiko Fukuda
- 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 However, the long-term survival of LAP for colorectal cancer is still unclear, especially for advanced colorectal cancer requiring extended lymphadenectomy. Thus, the investigators designed a study which investigates whether LAP is suitable for advanced colorectal cancer with respect to survival and post-operative morbidity.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1050
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Overall survival During the study conduct
- Secondary Outcome Measures
Name Time Method The proportion of conversion from LAP to OPEN operation day Short-term clinical outcomes time to 1st discharge after operation Relapse-free survival During the study conduct Adverse events During the study conduct The proportion of completion of LAP operation day
Trial Locations
- Locations (26)
Fujita Health University
🇯🇵Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan
Toho University Sakura Hospital
🇯🇵Sakura,Shimoshidu,564-1, Chiba, Japan
Jyuntendo Urayasu Hospital
🇯🇵Urayasu,Tomioka,2-1-1, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
🇯🇵Matsuyama,Horinouchi,13, Ehime, Japan
Kurume University School of Medicine
🇯🇵Kurume,Asahi-machi,67, Fukuoka, Japan
Hiroshima University, School of Medicine
🇯🇵Hiroshima,Minami-ku,Kasumi,1-2-3, Hiroshima, Japan
Ishikawa Prefectual Central Hospital
🇯🇵Kanazawa,Kuratsuki-Higashi,2-1, Ishikawa, Japan
Teikyo University Hospital, Mizonokuchi
🇯🇵Kawasaki,Takatsu-ku,Mizonokuchi,3-8-3, Kanagawa, Japan
Kitasato University East Hospital
🇯🇵Sagamihara,Asamizodai,2-1-1, Kanagawa, Japan
Scroll for more (16 remaining)Fujita Health University🇯🇵Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi, Japan