UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014965 |
|---|---|
| Receipt number | R000017419 |
| Scientific Title | Randomized, Prospective Comparison of Ursodiol in the Prevention of Gallstones after Sleeve Gastrectomy |
| Date of disclosure of the study information | 2014/08/27 |
| Last modified on | 2014/08/27 11:37:08 |
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Basic information
Public title
Randomized, Prospective Comparison of Ursodiol in the Prevention of Gallstones after Sleeve Gastrectomy
Acronym
Gallstone Prevention after Sleeve Gastrectomy
Scientific Title
Randomized, Prospective Comparison of Ursodiol in the Prevention of Gallstones after Sleeve Gastrectomy
Scientific Title:Acronym
Gallstone Prevention after Sleeve Gastrectomy
Region
| North America |
Condition
Condition
Gallstones after Weight Loss surgery
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study were (1)to identify the incidence of cholecystopathy (gallstones or sludge) after sleeve gastrectomy; and (2) to determine the effectiveness of ursodiol administration on prevention of cholecystopathy after sleeve gastrectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gallstone development; cholecystopathy development (stones or sludge)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Ursodiol prescription
Interventions/Control_2
No Ursodiol
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
| 17 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria were that individuals qualified for bariatric surgery according to the National Institutes of Health (1991) criteria (BMI> 35 with two co-morbidities or BMI>40 with none) and presented with healthy gallbladders, with normal liver enzymes (bilirubin, alkaline phosphatase, aspartate aminotransferase, and alanine aminotransferase), and were free of inflammation, obstruction, stones, and sludge as identified by abdominal ultrasound prior to surgery.
Key exclusion criteria
Individuals were excluded due to presence of cholecystopathy prior to surgery, previous cholecystectomy, history of ileostomy or ileoectomy, and presence of contraindications for ursodiol administration.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Lindsay Adams |
Organization
Dr. Craig Chang Weight Loss Clinic
Division name
not applicable
Zip code
Address
6502 Nursery Drive Suite 300; Victoria, Texas
TEL
361-570-8585
cchang@victoriasurgeon.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Lindsay Adams |
Organization
Dr. Craig Chang Weight Loss Clinic
Division name
not applicable
Zip code
Address
724 Taos
TEL
979-450-4423
Homepage URL
lindsay.adams@detar.com
Sponsor or person
Institute
Louisiana Tech University
Institute
Department
Personal name
Funding Source
Organization
Individual
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
Address
Tel
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
| 2014 | Year | 08 | Month | 27 | 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
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
| 2011 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 27 | Day |
Last modified on
| 2014 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017419
