UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030772 |
|---|---|
| Receipt number | R000035138 |
| Scientific Title | Randomized clinical trial of temporary ostomy reversal comparing purse-string approximation and primary closure with a drain |
| Date of disclosure of the study information | 2018/01/15 |
| Last modified on | 2018/01/11 18:54:28 |
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Basic information
Public title
Randomized clinical trial of temporary ostomy reversal comparing purse-string approximation and primary closure with a drain
Acronym
Randomized clinical trial of temporary ostomy reversal comparing purse-string approximation and primary closure with a drain
Scientific Title
Randomized clinical trial of temporary ostomy reversal comparing purse-string approximation and primary closure with a drain
Scientific Title:Acronym
Randomized clinical trial of temporary ostomy reversal comparing purse-string approximation and primary closure with a drain
Region
| Japan |
Condition
Condition
Patients with colostomy or ileostomy
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Influence of skin closure techniques on their advantages, defects and complications after stoma reversal surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The healing rate of the wound
Key secondary outcomes
Infection rate of the wound
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Closed wound
Interventions/Control_2
Open wound
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with colostomy or ileostomy
Key exclusion criteria
None
Target sample size
126
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Ishida |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Digestive Tract and General Surgery
Zip code
Address
1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan
TEL
049-228-3619
05hishi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichiro Ishibashi |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Digestive Tract and General Surgery
Zip code
Address
1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan
TEL
049-228-3619
Homepage URL
k_ishi@saitama-med.ac.jp
Sponsor or person
Institute
Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
| 2018 | Year | 01 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2007 | Year | 03 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2018 | Year | 01 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 11 | Day |
Last modified on
| 2018 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035138
