UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006216 |
|---|---|
| Receipt number | R000007356 |
| Scientific Title | Periperative physiotherapy with the patients of esophageal cancer; Aiming to decrease the rate of pulmonary complication |
| Date of disclosure of the study information | 2011/08/25 |
| Last modified on | 2015/02/23 12:56:39 |
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Basic information
Public title
Periperative physiotherapy with the patients of esophageal cancer; Aiming to decrease the rate of pulmonary complication
Acronym
Perioperative physiotherapy with the patients of esophageal cancer
Scientific Title
Periperative physiotherapy with the patients of esophageal cancer; Aiming to decrease the rate of pulmonary complication
Scientific Title:Acronym
Perioperative physiotherapy with the patients of esophageal cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prove whether perioperative physiotherapy with the patients of esophageal cancer is involved in decreasing pulmonary complication, or not.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pulmonary complication, after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Period April,2011-Dec,2015
30 cases; preoperative physiotherapy group.
Interventions/Control_2
Period April,2011-Dec,2015
30 cases; no preoperative physiotherapy group.
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
The patients with esophageal cancer who is sheduled to underwent esophagectomy with gastric tube reconstruction in Fukuoka University School of Medicine.
Key exclusion criteria
Registrant of another clinical study.
Reconstruction of non gastric tube.
The case that we judge inappropriate.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ippei Yamana |
Organization
Department of Gastroenterological Surgery, Fukuoka University School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
Nanakuma 7-45-1, Jonan-ku, Fukuoka
TEL
092-801-1011
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ippei Yamana |
Organization
Department of Gastroenterological Surgery, Fukuoka University School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
TEL
09095053650
Homepage URL
Sponsor or person
Institute
Department of Gastroenterological Surgery, Fukuoka University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University School
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 08 | 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
| 2011 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 23 | Day |
Last modified on
| 2015 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007356
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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