A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer

Phase 3

Completed

• Conditions: Colorectal Cancer
• Interventions: Procedure: laparoscopic colectomy; Procedure: open colectomy

• 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.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-05
• Study First Submitted QC: 2005-09-05
• Study First Posted: 2005-09-07
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-22

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

Arm && Interventions

Group	Intervention	Description
2	laparoscopic colectomy	Procedure/Surgery: laparoscopic colectomy
1	open colectomy	Procedure/Surgery: open colectomy

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
The proportion of completion of LAP	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

Trial Locations

Locations (26)

Jyuntendo Urayasu Hospital; 🇯🇵 Urayasu,Tomioka,2-1-1, Chiba, Japan

Kitasato University East Hospital; 🇯🇵 Sagamihara,Asamizodai,2-1-1, Kanagawa, Japan

Oita University Faculty of Medicine; 🇯🇵 Yufu city,Hasama-machi, 1-1, Oita, Japan

National Cancer Center Hospital; 🇯🇵 Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan

National Hospital Organization Shikoku Cancer Center; 🇯🇵 Matsuyama,Horinouchi,13, Ehime, Japan

Ishikawa Prefectual Central Hospital; 🇯🇵 Kanazawa,Kuratsuki-Higashi,2-1, Ishikawa, Japan

Toranomon Hospital; 🇯🇵 Minato-ku,Toranomon,2-2-2, Tokyo, Japan

Toho University Sakura Hospital; 🇯🇵 Sakura,Shimoshidu,564-1, Chiba, Japan

Kitasato University School of Medichine; 🇯🇵 Sagamihara,Kitasato,1-15-1, Kanagawa, Japan

Omiya Medical Center, Jichi Medical School; 🇯🇵 Saitama,Omiya-ku,Amanuma-cho,1-847, Saitama, Japan

Toho University Ohashi Hospital; 🇯🇵 Meguro-ku,Ohashi,2-17-6, Tokyo, Japan

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

Kurume University School of Medicine; 🇯🇵 Kurume,Asahi-machi,67, Fukuoka, Japan

National Cancer Center Hospital East; 🇯🇵 Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan

Hiroshima University, School of Medicine; 🇯🇵 Hiroshima,Minami-ku,Kasumi,1-2-3, Hiroshima, Japan

Teikyo University Hospital, Mizonokuchi; 🇯🇵 Kawasaki,Takatsu-ku,Mizonokuchi,3-8-3, Kanagawa, Japan

Showa University Northern Yokohama Hospital; 🇯🇵 Yokohama,Tsuzuki-ku,Chigasakichuo,35-1, Kanagawa, Japan

Osaka University Graduate School of Medicine; 🇯🇵 Suita,Yamada-oka,2-2, Osaka, Japan

Osaka Medical College; 🇯🇵 Takatsuki,Daigakucho,2-7, Osaka, Japan

Tokyo Medical and Dental University Hospital; 🇯🇵 Bunkyo-ku,Yushima,1-5-45, Tokyo, Japan

Osaka City General Hospital; 🇯🇵 Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, Japan

National Hospital Organization Kyoto Medical Center; 🇯🇵 Kyoto,Fushimi-ku,Fukakusa,Mukaihata-cho,1-1, Kyoto, Japan

Nagano Municipal Hospital; 🇯🇵 Nagano,Tomitake,1333-1, Nagano, Japan

Sizuoka Cancer Center; 🇯🇵 Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, Japan

Kyorin University School of Medicine; 🇯🇵 Mitaka,Shinkawa,6-20-2, Tokyo, Japan

Keio University Hospital; 🇯🇵 Shinjuku-ku,Shinanomachi,35, Tokyo, Japan