Colorectal cancer
Conditions
Interventions
Standard procedure with 4-5 access ports in laparoscopic colorectal cancer excision
Reduced-port surgery with 1-2 access ports in laparoscopic colorectal cancer excision
Sponsors
Koga Community Hospital Department of Surgery
Teikyo University, Department of Surgery International University of Health and Welfare, Ichikawa hospital, Department of Gastroenterological surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histological proven colorectal carcinoma, clinical stage 0-III 2) Radical cure resection with D2-D3 lymph node dissection is scheduled. 3) Tumor location; Cecum, Ascending colon, Transverse colon, Descending colon, Sigmoid colon and Rectosigmoid colon 4) Tumor diameter is 5.0cm or smaller 5) 20 years old or more 6) Performance Status (ECOG); 0-1 7) No severe dysfunction of internal organs (Fill everything the following with the inspection within 14 days before registration) White blood cell count > 2,000/mm3 and < 20,000/ mm3 Platelet number > 50,000/ mm3 Haemoglobin > 8.0 g/dl AST(GOT) ALT(GPT) < 5 times of facilities standard value upper bound Serum total bilirubin < 3.0 mg/dl Serum creatinine < 3.0 mg/dl 8) Patient who is obtaining agreement by explanation document
Exclusion criteria
Exclusion criteria: 1) Severe hypersensitivity 2) Synchronous or metachronous (within 5 years) malignancy other han carcinoma in situ 3) Active infectious disease 4) Severe mental disease 5) Pregnant or lactating women 6) Severe dysfunction of internal organs 7) History of the organ transplantation 8) Preoperative therapy (chemotherapy, radiotherapy and and hormonal therapy, etc.) 9) Improper patient for clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse event in postoperative 1 month or less | — |
Secondary
| Measure | Time frame |
|---|---|
| Short-term results (amount of blood loss, operative time, and duration of postoperative hospital stay) Health related QOL score Long-term results (5-year over-all survival rate and 5-year relapse-free survival rate) | — |
Countries
Japan
Contacts
Public ContactManabu Watanabe
Koga Community Hospital Division of medical technology
Outcome results
None listed