Unique ID issued by UMIN | UMIN000013489 |
---|---|
Receipt number | R000015756 |
Scientific Title | A Feasibility Study of Robot-Assisted Laparoscopic Surgery for the Treatment of Colorectal Cancers |
Date of disclosure of the study information | 2014/03/24 |
Last modified on | 2016/10/13 09:59:28 |
A Feasibility Study of Robot-Assisted Laparoscopic Surgery for the Treatment of Colorectal Cancers
A Feasibility Study of Robot-Assisted Laparoscopic Surgery for the Colorectal Cancers
A Feasibility Study of Robot-Assisted Laparoscopic Surgery for the Treatment of Colorectal Cancers
A Feasibility Study of Robot-Assisted Laparoscopic Surgery for the Colorectal Cancers
Japan |
Colorectal cancer
Gastrointestinal surgery |
Malignancy
NO
The purpose of this study is to examine the safety and efficacy of robot-assisted laparoscopic surgery for the colorectal cancers.
Safety,Efficacy
Intraoperative and postoperative morbidity rate, Ro resection rate
Treatment rate of robot-assisted laparoscopic surgery, Open conversion rate, Operative time, Blood loss, Number of lymph nodes harvested, Local recurrence rate, Overall survival, Relapse-free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
Robot-assisted laparoscopic operation using "da Vinci Surgical System" will be performed.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1. Colorectal cancer proven histologically.
2. Resectable stage I-III tumor.
3. No prior chemotherapy or radiotherapy for colorectal cancer.
4. ECOG PS 0-1.
5. Age 20-80.
6. Adequate organ function to perform the surgery.
7. Written informed consent.
1. Tumor with over 5cm in the maximum diameter.
2. Direct invasion into the surrounding organ.
3. Ileus.
4. Infectious disease in abdominal cavity.
5. Diffuse adhesion anticipated.
6. Serious co-morbidity, such as cardiopulmonary disease, bleeding tendency, uncontrollable diabetes mellitus or hypertension.
7. Pregnant or possibly pregnant women.
8. Other conditions judged ineligible by physician.
10
1st name | |
Middle name | |
Last name | Masafumi Nakamura,MD |
Graduate School of Medical Sciences, Kyushu University
Surgery and Oncology
Maidashi 3-1-1, Higashi-ku, Fukuoka, 812-8582, Japan
092-642-5437
mnaka@surg1.med.kyushu-u.ac.jp
1st name | |
Middle name | |
Last name | Tatsuya Manabe,MD |
Graduate School of Medical Sciences, Kyushu University
Surgery and Oncology
Maidashi 3-1-1, Higashi-ku, Fukuoka,
092-642-5440
manabe@surg1.med.kyushu-u.ac.jp
Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
None
Self funding
NO
九州大学病院(福岡県)
2014 | Year | 03 | Month | 24 | Day |
Unpublished
Open public recruiting
2013 | Year | 05 | Month | 03 | Day |
2014 | Year | 03 | Month | 25 | Day |
2014 | Year | 03 | Month | 23 | Day |
2016 | Year | 10 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015756