Effectiveness of Ursodeoxycholic Acid Use in the Prevention of Gallstone Formation After Sleeve Gastrectomy
Effectiveness of Ursodeoxycholic Acid Use in the Prevention of Gallstone Formation After Sleeve Gastrectomy
This is a randomized double-blind placebo-controlled trial with a total of 100 patients who
 are free of gallstones at baseline. The study involves taking an oral drug (Ursodeoxycholic
 Acid 250mg) or a placebo twice daily for a period of six months and undergoing a total of
 three abdominal ultrasounds (at 6 months, at 12 months, and at 18 months) to check for
 gallstones.
A significant proportion of patients are known to develop gallstones during the phase of
 rapid weight loss after bariatric surgery. A small percentage of these patients develop
 symptoms such as abdominal pain, nausea, vomiting, and occasionally more serious symptoms
 relating to gallbladder disease. Those patients may require surgery for the removal of their
 gallbladder even though the risks of gallbladder surgery are increased in this patient group.

 The investigators would like to provide patients who have undergone Laparoscopic Sleeve
 Gastrectomy a drug that will reduce the risk of developing gallstones during the phase of
 rapid weight loss after surgery. The drug, Ursodeoxycholic acid, is FDA approved for the
 reduction in gallstone formation in obese patients undergoing rapid weight loss but has never
 been proven effective, by randomized controlled studies, in the subgroup of obese patients
 undergoing Laparoscopic Sleeve Gastrectomy. If proven so, the investigators intend to
 influence the current practice such that all patients are offered Ursodeoxycholic Acid for
 the reduction of gallstone formation and their complications following Laparoscopic Sleeve
 Gastrectomy.

 In this randomized double-blind placebo-controlled trial, the subjects will be approached by
 the principal investigator in the clinic with information about taking part in this study,
 after the decision is made to undergo Laparoscopic Sleeve Gastrectomy for weight loss. The
 surgeon will answer any questions then and thereafter. The investigators will clarify that
 participation is voluntary and will not alter routine care whether the patient participates
 or not. The study involves taking an oral drug (Ursodeoxycholic Acid 250mg) twice daily for a
 period of six months and undergoing a total of three abdominal ultrasounds (at 6 months, at
 12 months, and at 18 months) to check for gallstones. Patients should be gallstone free on an
 initial ultrasound to satisfy the study inclusion criteria. Ultrasound testing is radiation
 free and does not pose any additional risk to the subjects.

 A total of 100 patients need to be recruited. The sample is comparable to current studies and
 is sufficient to prove or disprove the hypothesis with low risk of error (ref). The patients
 will either receive placebo or the drug under study, the placebo being dispensed from the
 pharmacy and having the same color as the ursodeoxycholic acid. The principal investigator
 and the radiologists measuring the result will be blinded to whether the subject receives the
 drug or placebo.

 The study needs to involve human subjects so that the results will be applicable to human
 subjects. The risk is small because the drug is FDA approved with 13 years post-marketing
 experience for related indications and is known to be well tolerated. All efforts will be
 made to protect the privacy and confidentiality of the subjects including protecting their
 personal information by removing identifiers from data records and storing the identifying
 codes in a separate location, with all study material under password protection or lock and
 key at all times.
Inclusion Criteria:

 -  Obese patients (body mass index > 35 kg/m2) undergoing laparoscopic sleeve gastrectomy
 as a primary treatment for their obesity.

 -  No gallstone disease on initial ultrasounds

 -  No previous cholecystectomy

 Exclusion Criteria:

 -  Bariatric patients with gallbladder stones on baseline ultrasound examination.

 -  Patients with a previous cholecystectomy