Unique ID issued by UMIN | UMIN000004030 |
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Receipt number | R000004846 |
Scientific Title | Randomized Trial between Buttressed Versus Nonbuttressed Stapling in Pulmonary Lobectomy |
Date of disclosure of the study information | 2010/08/11 |
Last modified on | 2012/02/13 10:20:16 |
Randomized Trial between Buttressed Versus Nonbuttressed Stapling in Pulmonary Lobectomy
Randomized Trial between Buttressed Versus Nonbuttressed Stapling in Pulmonary Lobectomy
Randomized Trial between Buttressed Versus Nonbuttressed Stapling in Pulmonary Lobectomy
Randomized Trial between Buttressed Versus Nonbuttressed Stapling in Pulmonary Lobectomy
Japan |
Scheduled to undergo pulmonary lobectomy
Chest surgery |
Malignancy
NO
The objective of this study was to confirm the superiority of a test treatment group using Endo GIA Duet TRS to a current international standard of care group using a conventional stapler in patients undergoing pulmonary lobectomy surgery, using a randomized comparative study of the frequency of intraoperative air leak.
Safety,Efficacy
Confirmatory
Phase III
Frequency of intraoperative air leak
Days of hospitalization, postoperative duration of air leak, duration of drain placement, frequency of intraoperative sealant use, percent occurrence of intraoperative adverse events, percent occurrence of postoperative adverse events
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Device,equipment | Maneuver |
A: Test treatment group using Endo GIA Duet TRS
B: Current international standard of care group using conventional stapler
20 | years-old | <= |
Not applicable |
Male and Female
1) Aged 20 years or older
2) Eligible for pulmonary lobectomy
3) Scheduled to undergo pulmonary lobectomy
4) Performance status 0-1 (ECOG classification)
5) No history of lung surgery
6) Healthy organ function
7) Scheduled for staple surgery
8) Wiiling and able to participate in the study procedures and able to understand and sign the informed consent
1) Has suffered thoracic trauma or has previously undergone lung surgery
2) Has an active bacterial infection or fungal infection
3) Undergoing continuing systemic administration (intravenous or oral) of steroids
4) Complicated by uncontrolled diabetes mellitus
5) Allergic to nickel chromium
6) Patient participation is judged difficult due to study complications related to a psychiatric disorder or psychological symptoms
7) Judged unsuitable for study participation by the investigator for any other reason
140
1st name | |
Middle name | |
Last name | Kenji Suzuki |
Juntendo University School of Medicine
General Thoracic Surgery
1-3, Hongo 3 chome, Bunkyo-ku, Tokyo 113-8431, Japan
03-3813-3111
1st name | |
Middle name | |
Last name | Kazuya Takamochi |
Juntendo University School of Medicine
General Thoracic Surgery
1-3, Hongo 3 chome, Bunkyo-ku, Tokyo 113-8431, Japan
03-3813-3111
Covidien Japan Inc.
Covidien Japan Inc.
Profit organization
YES
NCT01241617
ClinicalTrials.gov
順天堂大学医学部附属順天堂医院(東京)
2010 | Year | 08 | Month | 11 | Day |
Unpublished
Terminated
2010 | Year | 07 | Month | 01 | Day |
2010 | Year | 09 | Month | 01 | Day |
2012 | Year | 02 | Month | 01 | Day |
2012 | Year | 02 | Month | 01 | Day |
2012 | Year | 02 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2010 | Year | 08 | Month | 11 | Day |
2012 | Year | 02 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004846
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