UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051421 |
|---|---|
| Receipt number | R000058657 |
| Scientific Title | A prospective single-arm study to verify the preventative effect of Seprafilm for port-site adhesion in laparoscopic surgery |
| Date of disclosure of the study information | 2023/06/23 |
| Last modified on | 2023/06/23 08:56:16 |
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Basic information
Public title
A prospective single-arm study to verify the preventative effect of Seprafilm for port-site adhesion in laparoscopic surgery
Acronym
A second lool valideation study of Seprafilm for lap-TAMKO surgery
Scientific Title
A prospective single-arm study to verify the preventative effect of Seprafilm for port-site adhesion in laparoscopic surgery
Scientific Title:Acronym
A second lool valideation study of Seprafilm for lap-TAMKO surgery
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
validation study of seprafilm for prevention of adhesion in laparoscopic surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of adhesion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
use of Seprafilm
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
gastric cancer patients who undergo staging laparoscopy followed by radical surgery
Key exclusion criteria
frail patients
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Dai |
| Middle name | |
| Last name | Manaka |
Organization
Kyoto Katsura Hospital
Division name
Department of Surgery
Zip code
615-8256
Address
17 Hirao-cho Yamada Nisikyo-ku Kyoto Japan
TEL
075-391-5811
yasuhiro.saito812@gmail.com
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Saito |
Organization
Kyoto Katsura Hospital
Division name
Department of Surgery
Zip code
615-8256
Address
17 Hirao-cho Yamada Nisikyo-ku Kyoto Japan
TEL
075-391-5811
Homepage URL
yasuhiro.saito812@gmail.com
Sponsor or person
Institute
Kyoto Katsura Hospital
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
Kyoto Katsura Hospital
Address
17 Hirao-cho Yamada Nisikyo-ku Kyoto Japan
Tel
0753915811
yasuhiro.saito812@gmail.com
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
| 2023 | Year | 06 | Month | 23 | 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
55
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 23 | Day |
Last modified on
| 2023 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058657
