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A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer

Phase 3
Completed
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
Inclusion Criteria
  1. Histologically proven colorectal carcinoma
  2. Tumor located in the cecum, ascending colon, sigmoid colon, or rectosigmoid colon
  3. T3 or deeper lesion without involvement of other organs
  4. Without multiple lesion other than carcinoma in situ
  5. Cancer classified as N0-2 and M0, according to the TNM classification system
  6. Tumor size < 8 cm
  7. No bowel obstruction
  8. Age 20 < and > 75 years
  9. Sufficient organ function
  10. No history of gastrointestinal surgery
  11. No history of chemotherapy or radiotherapy
  12. Provided written informed consent
Exclusion Criteria
  1. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
  2. Severe pulmonary emphysema, interstitial pneumonitis, or ischemic heart disease
  3. Pregnant or lactating women
  4. Severe mental disease
  5. Continuous systemic steroid therapy

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Overall survivalDuring the study conduct
Secondary Outcome Measures
NameTimeMethod
The proportion of conversion from LAP to OPENoperation day
Short-term clinical outcomestime to 1st discharge after operation
Relapse-free survivalDuring the study conduct
Adverse eventsDuring the study conduct
The proportion of completion of LAPoperation 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

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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

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Fujita Health University
🇯🇵Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi, Japan

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