UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056782 |
|---|---|
| Receipt number | R000060074 |
| Scientific Title | Effect of laparoscopic sleeve gastrectomy on obstructive sleep apnea syndrome in patient with morbid obesity. |
| Date of disclosure of the study information | 2025/01/23 |
| Last modified on | 2025/01/22 13:10:07 |
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Basic information
Public title
Effect of laparoscopic sleeve gastrectomy on obstructive sleep apnea syndrome
Acronym
Effect of LSG on OSAS
Scientific Title
Effect of laparoscopic sleeve gastrectomy on obstructive sleep apnea syndrome in patient with morbid obesity.
Scientific Title:Acronym
Effect of LSG on OSAS in morbidly obese patient
Region
| Japan |
Condition
Condition
morbidly obese patients with obstructive sleep apnea syndrome
Classification by specialty
| Endocrinology and Metabolism | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of Laparoscopic sleeve gastrectomy on obstructive sleep apnea syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
CPAP withdrawal rate 1 year after surgery
Key secondary outcomes
AHI of 3 points at the start of weight loss treatment, before surgery (after medical weight loss) and 1 year after surgery
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing LSG with morbid obesity who have OSAS and who are using CPAP
Key exclusion criteria
Secondary obesity patients.
Pregnant women or patients who may be pregnancy.
Patients who cannot provide written informed consent.
Other patients deemed unsuitable as research subjects by the research director.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yamamoto |
Organization
JCHO Shiga Hospital
Division name
Medical Safety Management Department
Zip code
520-0846
Address
Fujimidai 16-1, Otsu, Shiga
TEL
077-537-3101
yhiroshi@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yamamoto |
Organization
JCHO Shiga Hospital
Division name
Medical Safety Management Department
Zip code
520-0846
Address
Fujimidai 16-1, Otsu, Shiga
TEL
077-537-3101
Homepage URL
yhiroshi@belle.shiga-med.ac.jp
Sponsor or person
Institute
Japan Community Health care Organization
Institute
Department
Personal name
Hiroshi Yamamoto
Funding Source
Organization
Japan Community Heal care Organization
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
JCHO Shiga Hostipat
Address
Fujimidai 16-1, Otsu, Shiga
Tel
077-537-3101
yhiroshi@belkle.shiga-med.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
JCHO滋賀病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 23 | 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
40
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
| 2023 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2028 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Dada including PSG, cephalometry, respiratory function test, BGA, ESS, will be collected when diagnosed,PSG before and 1 year after surgery.
Management information
Registered date
| 2025 | Year | 01 | Month | 22 | Day |
Last modified on
| 2025 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060074
