Rectal Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Histologically proven rectal adenocarcinoma 2) Distal extent of tumor must be in the rectum (within 15cm from the anal verge as determined via endoscopy or confirmed by barium enema or sagittal slice of MRI/CT) 3) Clinical Stage Tumor depth of invasion: T2, T3 or T4 Lymph node metastasis: N0, N1, N2 or N3 No distant metastasis: M0 4) Age more than 20years old 5) Elective (low) anterior resection with lymph node dissection around the inferior mesenteric artery 6) No previous surgery for middle colic artery or inferior mesenteric artery 7) Preserved organ function within 6 weeks before registraion White blood cell count>=3,000/ul Platelet cpunt>=100,000/ul GOT<=100 IU/L GPT<=100 IU/L Total bilirubin<=2.0 mg/dl Creatinine<=1.5 mg/dl 8) written informed consent
Exclusion criteria
Exclusion criteria: 1) Synchronous colorectal carcinoma 2) Pregnant women, possibly pregnant women, and nursing mothers 3) Complicated with psychosis 4) Myocardial infarction within six months or unstable angina 5) Severe pulmonary emphysema or pulmonary fibrosis 6) Uneder systemic steroid therapy 7) Required for a intersphincteric resection 8) Other conditions not suitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of anastomotic leakage | — |
Secondary
| Measure | Time frame |
|---|---|
| Conversion rate in lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery 3-year disease-free survival Exploratory study of the risk factor for anastomotic leakage | — |
Countries
Japan
Contacts
Osaka University Graduate School of Medicine Department of Surgery