UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045875 |
|---|---|
| Receipt number | R000052372 |
| Scientific Title | Evaluation of Four-hand Reduction for Obturator hernia with the Guidance of Sonography (FROGS) as a new treatment strategy for obturator hernia: a retrospective study |
| Date of disclosure of the study information | 2021/10/26 |
| Last modified on | 2023/12/30 22:06:26 |
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Basic information
Public title
Evaluation of Four-hand Reduction for Obturator hernia with the Guidance of Sonography (FROGS) as a new treatment strategy for obturator hernia: a retrospective study
Acronym
FROGS maneuver for obturator hernia
Scientific Title
Evaluation of Four-hand Reduction for Obturator hernia with the Guidance of Sonography (FROGS) as a new treatment strategy for obturator hernia: a retrospective study
Scientific Title:Acronym
FROGS maneuver for obturator hernia
Region
| Japan |
Condition
Condition
Obturator hernia
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the effectiveness of FROGS(Four-hand Reduction for Obturator hernia with the Guidance of Sonography)as a new treatment strategy for obturator hernia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of manual reduction
Key secondary outcomes
The bowel resection rate, postoperative complications and mortality within 30 days after hernia presentation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
A group of patients who underwent FROGS(after-FROGS group)
Interventions/Control_2
A group of patients who did not undergo FROGS(before-FROGS 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients with obturator hernia who were admitted to the Department of Surgery at Kurashiki Central Hospital between April 2016 and September 2020.
Key exclusion criteria
None
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Nagahisa |
Organization
Kurashiki Central Hospital
Division name
Department of Surgery
Zip code
7108602
Address
1-1-1, Miwa, Kurashiki, Okayama
TEL
086-422-0210
yn13967@kchnet.or.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Togawa |
Organization
Kurashiki Central Hospital
Division name
Department of Surgery
Zip code
7108602
Address
1-1-1, Miwa, Kurashiki, Okayama
TEL
086-422-0210
Homepage URL
yt16559@kchnet.or.jp
Sponsor or person
Institute
Kurshiki Central Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Kurashiki Central Hospital Review Board
Address
1-1-1, Miwa, Kurashiki, Okayama
Tel
086-422-0210
an16776@kchnet.or.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 | 10 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
43
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 10 | Month | 28 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 04 | 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
| 2021 | Year | 10 | Month | 26 | Day |
Last modified on
| 2023 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052372
