A multicenter, placebo-controlled, randomized, double-blind, prospective trial of prophylactic ursodiol for the prevention of gallstone formation following gastric-bypass-induced rapid weight loss
Previous studies have documented a high incidence of gallstone formation following gastric-bypass (GBP)-induced rapid weight loss in morbidly obese patients. This study was designed to determine if a 6-month regimen of prophylactic ursodiol might prevent the development of gallstones. A multicenter,...
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| Veröffentlicht in: | The American journal of surgery 1995, Vol.169 (1), p.91-97 |
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| creator | Sugerman, Harvey J. Brewer, William H. Shiffman, Mitchell L. Brolin, Robert E. Fobi, Mathias A.L. Linner, John H. MacDonald, Kenneth G. MacGregor, Alex M. Martin, Louis F. Oram-Smith, Jeffrey C. Popoola, Dapo Schirmer, Bruce D. Vickers, Florence F. |
| description | Previous studies have documented a high incidence of gallstone formation following gastric-bypass (GBP)-induced rapid weight loss in morbidly obese patients. This study was designed to determine if a 6-month regimen of prophylactic ursodiol might prevent the development of gallstones.
A multicenter, randomized, doubleblind, prospective trial evaluated 3 oral doses of ursodiol: 300, 600, and 1,200 mg versus placebo beginning within 10 days after surgery and continuing for 6 months or until gallstone development, for patients with a body mass index (BMI) ≥40 kg/m
2. All patients had normal intraoperative gallbladder sonography. Transabdominal sonography was obtained at 2, 4, and 6 months following surgery, or until gallstone formation.
Of 233 patients with at least one postoperative sonogram, 56 were randomized to placebo, 53 to 300 mg ursodiol, 61 to 600 mg ursodiol, and 63 to 1,200 mg ursodiol. Preoperative age, sex, race, weight, BMI, and postoperative weight loss were not significantly different between groups. Gallstone formation occurred at 6 months in 32%, 13%, 2%, and 6% of the patients on the respective doses. Gallstones were significantly (
P |
| doi_str_mv | 10.1016/S0002-9610(99)80115-9 |
| format | Article |
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A multicenter, randomized, doubleblind, prospective trial evaluated 3 oral doses of ursodiol: 300, 600, and 1,200 mg versus placebo beginning within 10 days after surgery and continuing for 6 months or until gallstone development, for patients with a body mass index (BMI) ≥40 kg/m
2. All patients had normal intraoperative gallbladder sonography. Transabdominal sonography was obtained at 2, 4, and 6 months following surgery, or until gallstone formation.
Of 233 patients with at least one postoperative sonogram, 56 were randomized to placebo, 53 to 300 mg ursodiol, 61 to 600 mg ursodiol, and 63 to 1,200 mg ursodiol. Preoperative age, sex, race, weight, BMI, and postoperative weight loss were not significantly different between groups. Gallstone formation occurred at 6 months in 32%, 13%, 2%, and 6% of the patients on the respective doses. Gallstones were significantly (
P <0.001) less frequent with ursodiol 600 and 1,200 mg than with placebo.
A daily dose of 600 mg ursodiol is effective prophylaxis for gallstone formation following GBP-induced rapid weight loss.</description><identifier>ISSN: 0002-9610</identifier><identifier>EISSN: 1879-1883</identifier><identifier>DOI: 10.1016/S0002-9610(99)80115-9</identifier><identifier>PMID: 7818005</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adolescent ; Adult ; Body mass ; Body mass index ; Body size ; Body weight ; Calculi ; Cholelithiasis - etiology ; Cholelithiasis - prevention & control ; Double-Blind Method ; Double-blind studies ; Female ; Gallbladder ; Gallstones ; Gastric bypass ; Gastric Bypass - adverse effects ; Humans ; Male ; Middle Aged ; Placebos ; Prophylaxis ; Prospective Studies ; Surgery ; Treatment Outcome ; Ultrasonic imaging ; Ursodeoxycholic acid ; Ursodeoxycholic Acid - administration & dosage ; Ursodeoxycholic Acid - therapeutic use ; Weight ; Weight Loss</subject><ispartof>The American journal of surgery, 1995, Vol.169 (1), p.91-97</ispartof><rights>1995</rights><rights>Copyright Elsevier Limited Jan 1995</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c440t-537cce9e757c692a43187b322c99fe90e890220fb4ca0fc01f9bfd5b8f7fcfac3</citedby><cites>FETCH-LOGICAL-c440t-537cce9e757c692a43187b322c99fe90e890220fb4ca0fc01f9bfd5b8f7fcfac3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0002961099801159$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,4010,27902,27903,27904,65309</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/7818005$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sugerman, Harvey J.</creatorcontrib><creatorcontrib>Brewer, William H.</creatorcontrib><creatorcontrib>Shiffman, Mitchell L.</creatorcontrib><creatorcontrib>Brolin, Robert E.</creatorcontrib><creatorcontrib>Fobi, Mathias A.L.</creatorcontrib><creatorcontrib>Linner, John H.</creatorcontrib><creatorcontrib>MacDonald, Kenneth G.</creatorcontrib><creatorcontrib>MacGregor, Alex M.</creatorcontrib><creatorcontrib>Martin, Louis F.</creatorcontrib><creatorcontrib>Oram-Smith, Jeffrey C.</creatorcontrib><creatorcontrib>Popoola, Dapo</creatorcontrib><creatorcontrib>Schirmer, Bruce D.</creatorcontrib><creatorcontrib>Vickers, Florence F.</creatorcontrib><title>A multicenter, placebo-controlled, randomized, double-blind, prospective trial of prophylactic ursodiol for the prevention of gallstone formation following gastric-bypass-induced rapid weight loss</title><title>The American journal of surgery</title><addtitle>Am J Surg</addtitle><description>Previous studies have documented a high incidence of gallstone formation following gastric-bypass (GBP)-induced rapid weight loss in morbidly obese patients. This study was designed to determine if a 6-month regimen of prophylactic ursodiol might prevent the development of gallstones.
A multicenter, randomized, doubleblind, prospective trial evaluated 3 oral doses of ursodiol: 300, 600, and 1,200 mg versus placebo beginning within 10 days after surgery and continuing for 6 months or until gallstone development, for patients with a body mass index (BMI) ≥40 kg/m
2. All patients had normal intraoperative gallbladder sonography. Transabdominal sonography was obtained at 2, 4, and 6 months following surgery, or until gallstone formation.
Of 233 patients with at least one postoperative sonogram, 56 were randomized to placebo, 53 to 300 mg ursodiol, 61 to 600 mg ursodiol, and 63 to 1,200 mg ursodiol. Preoperative age, sex, race, weight, BMI, and postoperative weight loss were not significantly different between groups. Gallstone formation occurred at 6 months in 32%, 13%, 2%, and 6% of the patients on the respective doses. Gallstones were significantly (
P <0.001) less frequent with ursodiol 600 and 1,200 mg than with placebo.
A daily dose of 600 mg ursodiol is effective prophylaxis for gallstone formation following GBP-induced rapid weight loss.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Body mass</subject><subject>Body mass index</subject><subject>Body size</subject><subject>Body weight</subject><subject>Calculi</subject><subject>Cholelithiasis - etiology</subject><subject>Cholelithiasis - prevention & control</subject><subject>Double-Blind Method</subject><subject>Double-blind studies</subject><subject>Female</subject><subject>Gallbladder</subject><subject>Gallstones</subject><subject>Gastric bypass</subject><subject>Gastric Bypass - adverse effects</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Placebos</subject><subject>Prophylaxis</subject><subject>Prospective Studies</subject><subject>Surgery</subject><subject>Treatment Outcome</subject><subject>Ultrasonic imaging</subject><subject>Ursodeoxycholic acid</subject><subject>Ursodeoxycholic Acid - 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etiology</topic><topic>Cholelithiasis - prevention & control</topic><topic>Double-Blind Method</topic><topic>Double-blind studies</topic><topic>Female</topic><topic>Gallbladder</topic><topic>Gallstones</topic><topic>Gastric bypass</topic><topic>Gastric Bypass - adverse effects</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Placebos</topic><topic>Prophylaxis</topic><topic>Prospective Studies</topic><topic>Surgery</topic><topic>Treatment Outcome</topic><topic>Ultrasonic imaging</topic><topic>Ursodeoxycholic acid</topic><topic>Ursodeoxycholic Acid - administration & dosage</topic><topic>Ursodeoxycholic Acid - therapeutic use</topic><topic>Weight</topic><topic>Weight Loss</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sugerman, Harvey J.</creatorcontrib><creatorcontrib>Brewer, William H.</creatorcontrib><creatorcontrib>Shiffman, Mitchell L.</creatorcontrib><creatorcontrib>Brolin, Robert E.</creatorcontrib><creatorcontrib>Fobi, Mathias A.L.</creatorcontrib><creatorcontrib>Linner, John H.</creatorcontrib><creatorcontrib>MacDonald, Kenneth G.</creatorcontrib><creatorcontrib>MacGregor, Alex M.</creatorcontrib><creatorcontrib>Martin, Louis F.</creatorcontrib><creatorcontrib>Oram-Smith, Jeffrey C.</creatorcontrib><creatorcontrib>Popoola, Dapo</creatorcontrib><creatorcontrib>Schirmer, Bruce D.</creatorcontrib><creatorcontrib>Vickers, Florence F.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Biotechnology Research Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>The American journal of surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sugerman, Harvey J.</au><au>Brewer, William H.</au><au>Shiffman, Mitchell L.</au><au>Brolin, Robert E.</au><au>Fobi, Mathias A.L.</au><au>Linner, John H.</au><au>MacDonald, Kenneth G.</au><au>MacGregor, Alex M.</au><au>Martin, Louis F.</au><au>Oram-Smith, Jeffrey C.</au><au>Popoola, Dapo</au><au>Schirmer, Bruce D.</au><au>Vickers, Florence F.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A multicenter, placebo-controlled, randomized, double-blind, prospective trial of prophylactic ursodiol for the prevention of gallstone formation following gastric-bypass-induced rapid weight loss</atitle><jtitle>The American journal of surgery</jtitle><addtitle>Am J Surg</addtitle><date>1995</date><risdate>1995</risdate><volume>169</volume><issue>1</issue><spage>91</spage><epage>97</epage><pages>91-97</pages><issn>0002-9610</issn><eissn>1879-1883</eissn><abstract>Previous studies have documented a high incidence of gallstone formation following gastric-bypass (GBP)-induced rapid weight loss in morbidly obese patients. This study was designed to determine if a 6-month regimen of prophylactic ursodiol might prevent the development of gallstones.
A multicenter, randomized, doubleblind, prospective trial evaluated 3 oral doses of ursodiol: 300, 600, and 1,200 mg versus placebo beginning within 10 days after surgery and continuing for 6 months or until gallstone development, for patients with a body mass index (BMI) ≥40 kg/m
2. All patients had normal intraoperative gallbladder sonography. Transabdominal sonography was obtained at 2, 4, and 6 months following surgery, or until gallstone formation.
Of 233 patients with at least one postoperative sonogram, 56 were randomized to placebo, 53 to 300 mg ursodiol, 61 to 600 mg ursodiol, and 63 to 1,200 mg ursodiol. Preoperative age, sex, race, weight, BMI, and postoperative weight loss were not significantly different between groups. Gallstone formation occurred at 6 months in 32%, 13%, 2%, and 6% of the patients on the respective doses. Gallstones were significantly (
P <0.001) less frequent with ursodiol 600 and 1,200 mg than with placebo.
A daily dose of 600 mg ursodiol is effective prophylaxis for gallstone formation following GBP-induced rapid weight loss.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>7818005</pmid><doi>10.1016/S0002-9610(99)80115-9</doi><tpages>7</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0002-9610 |
| ispartof | The American journal of surgery, 1995, Vol.169 (1), p.91-97 |
| issn | 0002-9610 1879-1883 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_77129193 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adolescent Adult Body mass Body mass index Body size Body weight Calculi Cholelithiasis - etiology Cholelithiasis - prevention & control Double-Blind Method Double-blind studies Female Gallbladder Gallstones Gastric bypass Gastric Bypass - adverse effects Humans Male Middle Aged Placebos Prophylaxis Prospective Studies Surgery Treatment Outcome Ultrasonic imaging Ursodeoxycholic acid Ursodeoxycholic Acid - administration & dosage Ursodeoxycholic Acid - therapeutic use Weight Weight Loss |
| title | A multicenter, placebo-controlled, randomized, double-blind, prospective trial of prophylactic ursodiol for the prevention of gallstone formation following gastric-bypass-induced rapid weight loss |
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