UMIN ID: C000000105
Registered date:01/09/2005
Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Colorectal Cancer(JCOG 0404,CRC Surg-LAP/OPEN)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Colorectal cancer |
| Date of first enrollment | 2004/11/01 |
| Target sample size | 818 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Surgery:open colectomy Surgery:laparoscopic colectomy |
Outcome(s)
| Primary Outcome | overall survival |
|---|---|
| Secondary Outcome | relapse-free survival, short-term clinical outcomes, adverse events, the proportion of conversion from LAP to OPEN, the proportion of completion of LAP |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Exclusion criteria are as follows: (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 |
Related Information
| Primary Sponsor | Japan Clinical Oncology Group(JCOG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) | NCT00147134 |
Contact
| public contact | |
| Name | Masafumi Inomata, MD |
| Address | 1-1 Hasama-machi, Yufu city, Oita, 879-5593, Japan Japan |
| Telephone | |
| JCOG_sir@ml.jcog.jp | |
| Affiliation | JCOG0404 Coordinating Office Oita University Faculty of Medicine |
| scientific contact | |
| Name | Seigo Kitano, MD, PhD |
| Address | 1-1 Hasama-machi, Yufu city, Oita, 879-5593, Japan Japan |
| Telephone | |
| Affiliation | Oita University Faculty of Medicine Gastroenterological Surgery |