UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043104 |
|---|---|
| Receipt number | R000049203 |
| Scientific Title | Current status of postoperative anastomotic leakage and treatment outcomes of endoscopic intervention in Kagawa prefecture |
| Date of disclosure of the study information | 2021/01/22 |
| Last modified on | 2023/01/25 20:25:21 |
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Basic information
Public title
Current status of postoperative anastomotic leakage and treatment outcomes of endoscopic intervention in Kagawa prefecture
Acronym
Current status of postoperative anastomotic leakage and treatment outcomes of endoscopic intervention in Kagawa prefecture
Scientific Title
Current status of postoperative anastomotic leakage and treatment outcomes of endoscopic intervention in Kagawa prefecture
Scientific Title:Acronym
Current status of postoperative anastomotic leakage and treatment outcomes of endoscopic intervention in Kagawa prefecture
Region
| Japan |
Condition
Condition
Anastomotic leakage after gastrointestinal surgery
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigating the current status of anastomotic leakage after gastrointestinal surgery and the outcome of endoscopic intervention to determine whether endoscopic intervention in refractory fistulas due to anastomotic leakages after gastrointestinal surgery can shorten the duration of illness
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical improvement rate by endoscopic intervention (%)
Key secondary outcomes
Occurrence of anastomotic leakage
Occurrence of anastomotic leakage for each organ
Refractory fistula transition rate
From surgery date to discovery date of anastomotic leakage
From discovery date of anastomotic leakage to fistula closure confirmation date
From discovery date of anastomotic leakage to endoscopic intervention date
From endoscopic intervention date to fistula closure confirmation date
Method of endoscopic intervention
Duration of hospitalization related to anastomotic leakage
Outcome
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Patients who underwent gastrointestinal resection due to gastrointestinal disease
The patient
Patients with all necessary data collection items recorded on electronic medical records
Key exclusion criteria
Patients who do not meet the selection criteria
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Tada |
Organization
Faculty of Medicine, Kagawa University
Division name
Department of Gastroenterology and Neurology
Zip code
7610793
Address
1750-1 Ikenobe, Miki, Kita, Kagawa, Japan
TEL
087-891-2156
n-tada@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Tada |
Organization
Faculty of Medicine, Kagawa University
Division name
Department of Gastroenterology and Neurology
Zip code
7610793
Address
1750-1 Ikenobe, Miki, Kita, Kagawa, Japan
TEL
087-891-2156
Homepage URL
n-tada@med.kagawa-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Kagawa University
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Faculty of Medicine, Kagawa University
Address
1750-1 Ikenobe, Miki, Kita, Kagawa, Japan
Tel
087-891-2156
n-tada@med.kagawa-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
| 2021 | Year | 01 | Month | 22 | 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
236
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
| 2020 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
N/A
Management information
Registered date
| 2021 | Year | 01 | Month | 22 | Day |
Last modified on
| 2023 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049203
