UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011143 |
|---|---|
| Receipt number | R000012316 |
| Scientific Title | Comparison of the frequency of peristomal infection related to the extension of skin incision for Percutaneous Endoscopic Gastrostomy: a prospective randomized study. |
| Date of disclosure of the study information | 2013/07/08 |
| Last modified on | 2023/01/16 11:11:22 |
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Basic information
Public title
Comparison of the frequency of peristomal infection related to the extension of skin incision for Percutaneous Endoscopic Gastrostomy: a prospective randomized study.
Acronym
Comparison of the frequency of peristomal infection related to the extension of skin incision for PEG.
Scientific Title
Comparison of the frequency of peristomal infection related to the extension of skin incision for Percutaneous Endoscopic Gastrostomy: a prospective randomized study.
Scientific Title:Acronym
Comparison of the frequency of peristomal infection related to the extension of skin incision for PEG.
Region
| Japan |
Condition
Condition
PEG due to dysphagia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to Compare the frequency of peristomal infection related to the extension of skin incision for Percutaneous Endoscopic Gastrostomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
peristomal infection
Key secondary outcomes
Complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
15mm-skin incision
Interventions/Control_2
25mm-skin incision
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Inability to tolerate oral intake.
(2)Obtained informed consent.
Key exclusion criteria
(1)For the purpose of gastric decompression.
(2)Not obtained informed consent.
Target sample size
98
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Shigoka |
Organization
Toho University Ohashi Medical Center
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
1538515
Address
2-22-36 Ohashi Meguro-ku, Tokyo, Japan
TEL
0334681251
h-shigoka@oha.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Yoshida |
Organization
Toho University Ohashi Medical Center
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
1538515
Address
2-22-36Ohashi Meguro-ku, Tokyo, Japan
TEL
03-3468-1251
Homepage URL
yuuki.yoshida@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Ohashi Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Toho University Ohashi Medical Center
Address
2-22-36 Ohashi Meguro-ku, Tokyo, Japan
Tel
03-3468-1251
ohashi.rinri@ext.toho-u.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
| 2013 | Year | 07 | Month | 08 | 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
98
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
| 2013 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 08 | Day |
Last modified on
| 2023 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012316
