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Risk factor of cholelithiasis is rapid weight loss after bariatric surgery and change in the gallbladder function which is secondary to surgery. Many observational studies support this fact, and a high incidence of 28% -71% after gastric bypass surgery (RYGB) was reported in them. According to another publication, the incidence of gallbladder diseases is 5-36% after jejunoileal bypass surgery and 2.8-36% after gastric bypass surgery.
Study format: Prospective, randomized, blinded study. 266 candidates for sleeve gastrectomy or gastric bypass surgery due to morbid obesity with BMI range of 40-50 and aged 18-65 will be studied.
The patients will be randomly divided into two groups (according to the last digit of the identity card number):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| URSODIOL - URSODEOXYCHOLIC ACID | Experimental | 300 mg twice a day |
|
| placebo | Placebo Comparator | placebo twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| URSODIOL | Drug | preventive treatment with Ursolit to reduce the incidence of gallstones formation after bariatric surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of gallstones formation after bariatric surgery | - Six months after the surgery the subjects will be invited to re-evaluation of the presence of gallstones using:
| six month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nasser Sakran, MD | Contact | +97246494491 | sakran_as@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Nasser Sakran, MD | Technion - Israel Institute of Technology, Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| surgery department A | Recruiting | Afula | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32666477 | Derived | Sakran N, Dar R, Assalia A, Neeman Z, Farraj M, Sherf-Dagan S, Gralnek IM, Hazzan R, Mokary SE, Nevo-Aboody H, Dola T, Kaplan U, Hershko D. The use of Ursolit for gallstone prophylaxis following bariatric surgery: a randomized-controlled trial. Updates Surg. 2020 Dec;72(4):1125-1133. doi: 10.1007/s13304-020-00850-2. Epub 2020 Jul 14. |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D002769 | Cholelithiasis |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D014580 | Ursodeoxycholic Acid |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
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| Placebo | Drug |
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |