Unique ID issued by UMIN | UMIN000006160 |
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Receipt number | R000007252 |
Scientific Title | The study to evaluate the efficacy of lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery for rectal cancer |
Date of disclosure of the study information | 2011/09/01 |
Last modified on | 2021/05/25 15:31:00 |
The study to evaluate the efficacy of lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery for rectal cancer
The efficacy of lymph node dissection with preservation of the left colic artery for rectal cancer
The study to evaluate the efficacy of lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery for rectal cancer
The efficacy of lymph node dissection with preservation of the left colic artery for rectal cancer
Japan |
Rectal Cancer
Surgery in general | Gastrointestinal surgery | Adult |
Malignancy
NO
To evaluate the efficacy of lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery for rectal cancer surgery in reducing incidence of anastomotic leakage
Efficacy
Incidence of anastomotic leakage
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
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
2
Treatment
Maneuver |
lymph node dissection around the inferior mesenteric artery without preservation of the left colic artery
lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery
20 | years-old | <= |
Not applicable |
Male and Female
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
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
1460
1st name | |
Middle name | |
Last name | Mitsugu Sekimoto |
Osaka University Hospital
Department of Surgery
2-2 Yamadaoka Suita City Osaka
06-6879-3251
1st name | |
Middle name | |
Last name | Masataka Ikeda Tsunekazu Mizushima |
Osaka University Graduate School of Medicine
Department of Surgery
2-2 Yamadaoka, Suita, Osaka 565-0871,Japan
06-6879-3251
tmizushima@gesurg.med.osaka-u.ac.jp
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
None
Self funding
NO
2011 | Year | 09 | Month | 01 | Day |
Unpublished
No longer recruiting
2011 | Year | 07 | Month | 22 | Day |
2011 | Year | 10 | Month | 01 | Day |
2011 | Year | 08 | Month | 12 | Day |
2021 | Year | 05 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007252
Research Plan | |
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Registered date | File name |
2016/07/06 | ★直腸癌手術における左結腸動脈温存の意義に関する検討 (2).zip |
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