UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008458 |
|---|---|
| Receipt number | R000009945 |
| Scientific Title | The Effect of Sliding Functional End-to-End Anastomosis in Colon Cancer Surgery: Randomized Controlled Trial |
| Date of disclosure of the study information | 2012/07/18 |
| Last modified on | 2012/07/17 17:50:57 |
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Basic information
Public title
The Effect of Sliding Functional End-to-End Anastomosis in Colon Cancer Surgery: Randomized Controlled Trial
Acronym
Sliding Functional End-to-End Anastomosis in Colon Cancer Surgery
Scientific Title
The Effect of Sliding Functional End-to-End Anastomosis in Colon Cancer Surgery: Randomized Controlled Trial
Scientific Title:Acronym
Sliding Functional End-to-End Anastomosis in Colon Cancer Surgery
Region
| Japan |
Condition
Condition
Colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effect of sliding functional end-to-end anastomosis in colon cancer surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The frequency of anastomotic complications including leakage, hemorrhage, and stenosis.
Key secondary outcomes
Time for anastomosis, the length of hospital stay, time for the recovery of bowel movement, the frequency of surgical site infection (SSI)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
During colon cancer surgery, sliding functional end-to-end anastomosis is applied for intestinal anastomosis.
Interventions/Control_2
During colon cancer surgery, conventional functional end-to-end anastomosis is applied for intestinal anastomosis.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Histologically proven colon cancer
2.Bowel resection and anastomosis
3.Written informed consent
4.Age ranging between 20 and 89 years old
5.Function of main organs is well preserved
Key exclusion criteria
1.Rejected to be included
2.Intestinal obstruction
3.Stoma creation
4.Considered inadequate for the inclusion
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihisa Matsuda |
Organization
Nippon Medical School, Chiba-Hokuso Hospital
Division name
Department of Surgery
Zip code
Address
Kamagari 1715, Inzai, Chiba, Japan 270-1694
TEL
0476-99-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihisa Matsuda |
Organization
Nippon Medical School, Chiba-Hokuso Hospital
Division name
Department of Surgery
Zip code
Address
Kamagari 1715, Inzai, Chiba, Japan 270-1694
TEL
0476-99-1111
Homepage URL
a-matsu@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School, Chiba-Hokuso Hospital
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School, Chiba-Hokuso Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
日本医科大学千葉北総病院(千葉県)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 18 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2013 | Year | 08 | Month | 18 | Day |
Date of closure to data entry
| 2013 | Year | 08 | Month | 18 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 17 | Day |
Last modified on
| 2012 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009945
