Determining the effect of ursodeoxycholic acid drug on gallstones in patients undergoing bariatric surgery and with asymptomatic cholecystitis before surgery.
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase one on 60 patients, is prepared for randomization using the method of four random blocks. The randomization unit is individual and the randomization tool is PASS11 statistical software
Settings and conduct
This study is a randomized clinical trial including 60 patients with morbid obesity and asymptomatic gallstones, which was designed in a double-blind manner. Patients referred to the obesity research center of Hazrat Fatemeh Hospital are randomly divided into the following two groups (randomized block method): The first treatment group is the use of ursodeoxycholic acid 300 mg twice a day for six months. The second treatment group will be placebo for 6 months. Before and after the intervention, the number and size of gallstones are measured by ultrasound. All ultrasounds are performed by a single radiologist and a single ultrasound machine. will not be included in the study group.
Participants/Inclusion and exclusion criteria
Inclusion criteria include morbidly obese patients who are candidates for bariatric surgery (Sleeve, Classic Bypass or OAGB) and have asymptomatic gallstones.
Intervention groups
The group receiving the medicine will receive UDCA capsules (Ursobil) made by the AANIDARMAN company with a dose of 300 mg every 12 hours for 6 months for free. The control group also receives a placebo drug with the same appearance as the main drug for the same duration
Main outcome variables
number of gallstones; The size of gallstones; complications of gallstones
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190128042520N5
Registration date:2024-01-26, 1402/11/06
Registration timing:prospective
Last update:2024-01-26, 1402/11/06
Update count:0
Registration date
2024-01-26, 1402/11/06
Registrant information
Name
Mohammad Kermansaravi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8809 5451
Email address
kermansaravi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of effect of Ursodeoxycholic acid on gallstone in pateint undergoing bariatric surgery while having asymptomatic gallstone
Public title
Evaluation of Ursodeoxycholic acid effect on gallstone in pateint undergoing bariatric surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria include morbidly obese patients who are candidates for bariatric surgery (Sleeve, Classic Bypass or OAGB) and have asymptomatic gallstones.
Exclusion criteria:
Patients with symptomatic gallstones
Impaired liver tests
History of previous bariatric surgery
History of taking Ursodeoxycholic acid during the last month of pregnancy
history of taking Oral contraceptive pills (OCP)
Drug and alcohol abuse
Sensitivity to Ursodeoxycholic acid
Age
From 18 years old to 75 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization list including 60 patients is prepared using the four random blocks method. The randomization unit is individual and the randomization tool is PASS11 statistical software and is at the disposal of the statistical expert of the project (that is, the person who performs the patient allocation and in (patient assessment does not play a role). In addition to blinding, the preparation of the randomized list ensures concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study participant,radiologist(outcome evaluator) and principal researcher will be blind.Both intervention and control groups recieve completely identical tablets and they will not know about their groups.
A radiologist who measures the size and number of Gallstones and principal researcher enters the results do not know about participant Group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ehtics Committee of Iran University of Medical Sciences
Street address
Fifth floor, Headquarter., Iran university of Medical Sciences., between Chamran and Sheikh Fazlollah., Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2024-01-16, 1402/10/26
Ethics committee reference number
IR.IUMS.FMD.REC.1402.406
Health conditions studied
1
Description of health condition studied
Morbid Obesity
ICD-10 code
E66.01
ICD-10 code description
Morbid (severe) obesity due to excess calories
Primary outcomes
1
Description
Size of gallstones
Timepoint
Measuring the size of gallstones at the beginning of the study (before the start of the intervention) and after the completion of the ursodeoxycholic acid drug (6 months after surgery)
Method of measurement
With sonography to mm
2
Description
number of gallstones
Timepoint
Measuring the number of gallstones at the beginning of the study (before the start of the intervention) and after the completion of the ursodeoxycholic acid drug (6 months after surgery)
Method of measurement
With sonography to number
Secondary outcomes
1
Description
nausea
Timepoint
One, three and six months after surgery
Method of measurement
Examination by a doctor
2
Description
Vomitting
Timepoint
One, three and six months after surgery
Method of measurement
Examination by a doctor
3
Description
Upper abdominal pain
Timepoint
One, three and six months after surgery
Method of measurement
Examination by a doctor
4
Description
early satiety
Timepoint
One, three and six months after surgery
Method of measurement
Examination by a doctor
Intervention groups
1
Description
Intervention group: The group receiving the drug will receive UDCA capsules (Ursobil) made by the AANIDARMAN company with a dose of 300 mg every 12 hours for 6 months for free.
Category
Treatment - Drugs
2
Description
Control group: The control group also receives a placebo medicine with the same appearance as the original medicine every 12 hours for 6 months for free
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Fateme Hospital
Full name of responsible person
Mohammad Kerman Saravi
Street address
Youssef Abad - Seyed Jamaluddin Asadabadi Street - 21 Street
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
crtfatima@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Iran University of Medical Science., Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Kerman Saravi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Yousef Abad
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
mkermansaravi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Kerman Saravi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Yousef Abad
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
mkermansaravi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoumeh Shahsavan
Position
Education Expert
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Habib Zadegan
City
Tehran
Province
Tehran
Postal code
1458886944
Phone
+98 21 3689 1809
Email
mashahsavan@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD