UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001390 |
|---|---|
| Receipt number | R000001690 |
| Scientific Title | Prospective randomized trial for determination of optimum size of side limb in low anterior resection with side-to-end anastomosis for rectal carcinoma |
| Date of disclosure of the study information | 2008/09/25 |
| Last modified on | 2008/09/24 14:11:28 |
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Basic information
Public title
Prospective randomized trial for determination of optimum size of side limb in low anterior resection with side-to-end anastomosis for rectal carcinoma
Acronym
Optimum size of side limb in low anterior resection with side-to-end anastomosis
Scientific Title
Prospective randomized trial for determination of optimum size of side limb in low anterior resection with side-to-end anastomosis for rectal carcinoma
Scientific Title:Acronym
Optimum size of side limb in low anterior resection with side-to-end anastomosis
Region
| Japan |
Condition
Condition
prospective randomized trial
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Functional outcome after low anterior resection with side-to-end anastomosis is comparable with colonic J-pouch. Optimum size of the side limb has yet to be determined. Therefore, we initiated a prospective randomized trial using 3 cm side limb (short limb) and 6 cm side limb (long limb) to determine this size.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional outcomes after 3 cm side limb (short limb) and 6 cm side limb (long limb)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
3 cm side limb
Interventions/Control_2
6 cm side limb
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with middle to low rectal carcinoma
Key exclusion criteria
unresectable tumor
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Tsunoda |
Organization
Showa University School of Medicine
Division name
Department of Gastroenterological and General Surgery
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8666 JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Showa University
Division name
School of Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Gastroenterological and General Surgery
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological and General Surgery
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 09 | Month | 25 | 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
Completed
Date of protocol fixation
| 2004 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 09 | Month | 24 | Day |
Last modified on
| 2008 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001690
