UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029543 |
|---|---|
| Receipt number | R000033729 |
| Scientific Title | A Prospective Study, Multi-center Investigation of Impact of the Reinforced Staple Technology during Anastomosis of Laparoscopic Rectal Surgery |
| Date of disclosure of the study information | 2017/10/15 |
| Last modified on | 2021/10/16 16:41:26 |
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Basic information
Public title
A Prospective Study, Multi-center Investigation of Impact of the Reinforced Staple Technology during Anastomosis of Laparoscopic Rectal Surgery
Acronym
A Prospective Study, Multi-center Investigation of Impact of the Reinforced Staple Technology during Anastomosis of Laparoscopic Rectal Surgery
Scientific Title
A Prospective Study, Multi-center Investigation of Impact of the Reinforced Staple Technology during Anastomosis of Laparoscopic Rectal Surgery
Scientific Title:Acronym
A Prospective Study, Multi-center Investigation of Impact of the Reinforced Staple Technology during Anastomosis of Laparoscopic Rectal Surgery
Region
| Japan |
Condition
Condition
Colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of
The Reinforced Stapler on laparoscopic rectal cancer surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of anastomotic leakage.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients undergoing laparoscopic rectal cancer resection and anastomosis (regardless of cancer stage);
2)Patients with an ECOG PS of 0 or 1;
3)Patients aged at least 20 years;
4)Patients who have given written consent to participate in the study; and
5)Patients with the distal margin of rectal cancer at 15 cm or less from the anal verge.
Key exclusion criteria
1)Patients with serious ischemic heart disease;
2)Patients with cirrhosis or active hepatitis;
3)Patients with dyspnea requiring oxygen administration;
4)Patients under dialysis due to chronic renal failure;
5)Patients requiring combined resection of any other organ; or
6)Patients ineligible for the study for any other reason, as judged by the investigator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Takemasa |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
060-8543
Address
Sapporo, Hokkaido 060-8543, Japan
TEL
011-611-2111
itakemasa@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Toshihiko |
| Middle name | |
| Last name | Nishidate |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
060-8543
Address
Sapporo, Hokkaido 060-8543, Japan
TEL
011-611-2111
Homepage URL
nisidate@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Covidien Japan Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University
Address
Minami1-Nishi16, cyuo-ku, Sapporo, Hokkaido
Tel
011-611-2111
rskk@sapmed.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
307
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
In the analysis
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
To assess the safety and efficacy of
The Reinforced Stapler in rectum resection on laparoscopic rectum cancer surgery.
Management information
Registered date
| 2017 | Year | 10 | Month | 13 | Day |
Last modified on
| 2021 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033729
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
