Colorectal cancer
Conditions
Interventions
1)Single incision laparoscopic surgery: All trocars passes a special platform via a single wound. Addition of one trocar because of transection of colon or insertion of drainage tube is allowed. It is
Sponsors
Yokohama City University Medical Center
Yokohama Clinical Oncolgy Group (YCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adenocarcinoma in histology 2) Lymphadenectomy in radical cure is planned. 3) Tumor location is in either the cecum, ascending, sigmoid or rectosigmoid colon. 4) The minimum length of tumor is 4.0cm or less. 5) Patient is 20 years old or more to 80 years old or less. 6) Patient's performance status(ECOG) is 0-1. 7) There is not an advanced disturbance in the main internal organs function (Fill everything the following with the examination within 14 days before registration). 1. White blood cell count >=3,000/mm3 and <=12,000/ mm3 2. Platelet number >=100,000/ mm3 3. Hemoglobin >= 9.0 g/dl 4. AST(GOT) and ALT(GPT) <= standard value upper bound in institute x2.5 5.Serum total bilirubin <= 1.5 mg/dl 6.Serum creatinine <= 1.5 mg/dl 8) Informed consent with document
Exclusion criteria
Exclusion criteria: 1) Severe hypersensitivity 2) Multiple cancer (Simultaneous or metachronous multiple cancer which disease-free interval is five years or less. However, a lesion of carcinoma in situ and intramucosal carcinoma are allowed.) 3) Active infectious disease 4) The past history of the mental disease and/or the central nervous system damage that becomes a clinical problem 5) Pregnant woman, lactating woman and woman who has possibility of pregnancy (intention). 6) Severe concomitant disease (Cardiorespiratory dysfunction, renal failure, intestinal paralysis, intestinal obstruction, uncontrolled diabetes melitus, liver cirrhosis and chronic hepatitis A and C, etc) 7) The past history of the organ transplantation 8) Preoperative treatment (chemotherapy, radiation therapy, and hormonal therapy, etc.) for colorectal cancer 9) Patient who judged that examination responsibility doctor is improper as subject of clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence ratio of adverse event within postoperative one month | — |
Secondary
| Measure | Time frame |
|---|---|
| Health related QOL score and patient satisfaction related to incised wound at the time of postoperative one month Short-term outcomes including operative time, amount of blood loss, postoperative stay and amount of analgesic use Long-term outcomes including 5-year overall survival and relapse-free survival | — |
Countries
Japan
Contacts
Public ContactJun Watanabe
Yokohama City University Medical Center Gastroenterological Center
Outcome results
None listed