Unique ID issued by UMIN | UMIN000008302 |
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Receipt number | R000009655 |
Scientific Title | A single-arm prospective observational study of the Safety and Performance of the DST using Tri-Staple in Laparoscopic left colectomy and rectal resection |
Date of disclosure of the study information | 2012/06/29 |
Last modified on | 2017/01/05 08:40:17 |
A single-arm prospective observational study of the Safety and Performance of the DST using Tri-Staple in Laparoscopic left colectomy and rectal resection
A single-arm prospective observational study of the Safety and Performance of the DST using Tri-Staple in Laparoscopic left colectomy and rectal resection
A single-arm prospective observational study of the Safety and Performance of the DST using Tri-Staple in Laparoscopic left colectomy and rectal resection
A single-arm prospective observational study of the Safety and Performance of the DST using Tri-Staple in Laparoscopic left colectomy and rectal resection
Japan |
Colorectal cancer
Gastrointestinal surgery |
Malignancy
NO
To investigate the efficacy and safety of Endo GIA Tri-Staple in laparoscopic left colectomy and rectal resection with DST anastomosis.
Safety,Efficacy
Number of staples used and the condition on rectal stump
Interventional
Single arm
Non-randomized
Single blind -participants are blinded
Active
1
Treatment
Device,equipment |
Endo GIA Tri-Staple
20 | years-old | <= |
Not applicable |
Male and Female
1) 20 years old or older (no upper limit)
2) Patients scheduled for DST anastomosis after laparoscopic left colectomy or rectal resection.
3) No history of abdominal surgery(except appendectomy)
4) Eastern Cooperative Oncology Group Scale of Performance Status (ECOG PS) of either 0 or 1
5) Healthy organ function
6) Written informed consent is obtained from the patient him/herself
1) laparoscopic surgery under reduced port surgery
2) Patients having pregnant, nursing or probability of pregnancy
3) Patients receiving continued systemic (oral or intravenous) steroids
4) tients with uncontrolled diabetes mellitus (HbA1c >8.0%)
5) Patients having allergic reaction to nickel-chromium alloy
6) Judged difficulty due to study complications related to a psychiatric disorder or psychological symptoms
7) Judged unsuitable patient for study participation by the investigator for any other reason
50
1st name | |
Middle name | |
Last name | Hirotoshi Hasegawa, M.D. |
Keio University School of Medicine
Keio University School of Medicine
35 Shinanomachi, Shinjuku-ku, Tokyo Japan
1st name | |
Middle name | |
Last name | Koji Okabayashi |
Keio University School of Medicine
Department of Surgery
03-3353-1211
Keio University School of Medicine, Department of Surgery
Covidien Japan Inc.
Profit organization
NO
2012 | Year | 06 | Month | 29 | Day |
Unpublished
Completed
2011 | Year | 12 | Month | 21 | Day |
2012 | Year | 07 | Month | 01 | Day |
2012 | Year | 06 | Month | 29 | Day |
2017 | Year | 01 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009655
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