Protein Malnutrition Clinical Trial
— BPD-to-RYGBOfficial title:
Another Revisional Strategy to Address Severe Late Complications After Previous Biliopancreatic Diversion for Obesity: Major Revision From Standard Biliopancreatic Diversion to Proximal Roux-en-Y Gastric Bypass
The aim of this study is to describe the clinical presentation, indications, and operative treatment as well as assess the morbidity, mortality, and overall performance of revisional GBP after either failed and/or complicated Biliopancreatic Diversion "BPD" for weight loss. With such information, we hope to determine what features might assist us in advancing our knowledge about mechanisms of failure after primary bariatric surgery, mechanism of action of revisional GBP, and performance of revisional GBP through traditional outcome measurements as well as identifying predictors of good or poor outcome after revisional GBP in this specific subpopulation.
Status | Completed |
Enrollment | 10 |
Est. completion date | October 2009 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients status post biliopancreatic diversion with any combination of the following severe late complications: - Metabolic and/or nutritional BPD-related complications. - Excessive weight loss - Poor weight loss, either Inadequate initial weight loss or Weight recidivism - Intolerable intestinal malabsorptive symptoms without severe malnutrition - Undergoing either open or laparoscopic conversion to Roux-en-Y gastric bypass (RYGB) surgery. Exclusion Criteria: - Any other type of revision or conversion surgery. - Adequate response to medical management of metabolic and nutritional complications after previous BPD - missing records and/or unreachable patients with scant information for analysis |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United States | UCSF Fresno Center for Medical Education and Research | Fresno | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Adams TD, Gress RE, Smith SC, Halverson RC, Simper SC, Rosamond WD, Lamonte MJ, Stroup AM, Hunt SC. Long-term mortality after gastric bypass surgery. N Engl J Med. 2007 Aug 23;357(8):753-61. — View Citation
Allied Health Sciences Section Ad Hoc Nutrition Committee, Aills L, Blankenship J, Buffington C, Furtado M, Parrott J. ASMBS Allied Health Nutritional Guidelines for the Surgical Weight Loss Patient. Surg Obes Relat Dis. 2008 Sep-Oct;4(5 Suppl):S73-108. doi: 10.1016/j.soard.2008.03.002. Epub 2008 May 19. — View Citation
Avinoah E, Ovnat A, Charuzi I. Nutritional status seven years after Roux-en-Y gastric bypass surgery. Surgery. 1992 Feb;111(2):137-42. — View Citation
Bell NH, Greene A, Epstein S, Oexmann MJ, Shaw S, Shary J. Evidence for alteration of the vitamin D-endocrine system in blacks. J Clin Invest. 1985 Aug;76(2):470-3. — View Citation
Boylan LM, Sugerman HJ, Driskell JA. Vitamin E, vitamin B-6, vitamin B-12, and folate status of gastric bypass surgery patients. J Am Diet Assoc. 1988 May;88(5):579-85. — View Citation
Brolin RE, Gorman JH, Gorman RC, Petschenik AJ, Bradley LB, Kenler HA, Cody RP. Prophylactic iron supplementation after Roux-en-Y gastric bypass: a prospective, double-blind, randomized study. Arch Surg. 1998 Jul;133(7):740-4. — View Citation
Brolin RE, Gorman JH, Gorman RC, Petschenik AJ, Bradley LJ, Kenler HA, Cody RP. Are vitamin B12 and folate deficiency clinically important after roux-en-Y gastric bypass? J Gastrointest Surg. 1998 Sep-Oct;2(5):436-42. — View Citation
Brolin RE, Gorman RC, Milgrim LM, Kenler HA. Multivitamin prophylaxis in prevention of post-gastric bypass vitamin and mineral deficiencies. Int J Obes. 1991 Oct;15(10):661-7. — View Citation
Brolin RE, LaMarca LB, Kenler HA, Cody RP. Malabsorptive gastric bypass in patients with superobesity. J Gastrointest Surg. 2002 Mar-Apr;6(2):195-203; discussion 204-5. — View Citation
Brolin RE, Leung M. Survey of vitamin and mineral supplementation after gastric bypass and biliopancreatic diversion for morbid obesity. Obes Surg. 1999 Apr;9(2):150-4. — View Citation
Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. Review. Erratum in: JAMA. 2005 Apr 13;293(14):1728. — View Citation
Buffington C, Walker B, Cowan GS Jr, Scruggs D. Vitamin D Deficiency in the Morbidly Obese. Obes Surg. 1993 Nov;3(4):421-424. — View Citation
Chapin BL, LeMar HJ Jr, Knodel DH, Carter PL. Secondary hyperparathyroidism following biliopancreatic diversion. Arch Surg. 1996 Oct;131(10):1048-52; discussion 1053. — View Citation
Christou NV, Sampalis JS, Liberman M, Look D, Auger S, McLean AP, MacLean LD. Surgery decreases long-term mortality, morbidity, and health care use in morbidly obese patients. Ann Surg. 2004 Sep;240(3):416-23; discussion 423-4. — View Citation
Coates PS, Fernstrom JD, Fernstrom MH, Schauer PR, Greenspan SL. Gastric bypass surgery for morbid obesity leads to an increase in bone turnover and a decrease in bone mass. J Clin Endocrinol Metab. 2004 Mar;89(3):1061-5. — View Citation
Compston JE, Vedi S, Ledger JE, Webb A, Gazet JC, Pilkington TR. Vitamin D status and bone histomorphometry in gross obesity. Am J Clin Nutr. 1981 Nov;34(11):2359-63. — View Citation
Cremieux PY, Buchwald H, Shikora SA, Ghosh A, Yang HE, Buessing M. A study on the economic impact of bariatric surgery. Am J Manag Care. 2008 Sep;14(9):589-96. — View Citation
Davies DJ, Baxter JM, Baxter JN. Nutritional deficiencies after bariatric surgery. Obes Surg. 2007 Sep;17(9):1150-8. Review. — View Citation
DeMaria EJ. Is gastric bypass superior for the surgical treatment of obesity compared with malabsorptive procedures? J Gastrointest Surg. 2004 May-Jun;8(4):401-3. — View Citation
Dolan K, Hatzifotis M, Newbury L, Fielding G. A comparison of laparoscopic adjustable gastric banding and biliopancreatic diversion in superobesity. Obes Surg. 2004 Feb;14(2):165-9. — View Citation
Dolan K, Hatzifotis M, Newbury L, Lowe N, Fielding G. A clinical and nutritional comparison of biliopancreatic diversion with and without duodenal switch. Ann Surg. 2004 Jul;240(1):51-6. — View Citation
Faintuch J, Matsuda M, Cruz ME, Silva MM, Teivelis MP, Garrido AB Jr, Gama-Rodrigues JJ. Severe protein-calorie malnutrition after bariatric procedures. Obes Surg. 2004 Feb;14(2):175-81. — View Citation
Flancbaum L, Belsley S, Drake V, Colarusso T, Tayler E. Preoperative nutritional status of patients undergoing Roux-en-Y gastric bypass for morbid obesity. J Gastrointest Surg. 2006 Jul-Aug;10(7):1033-7. — View Citation
Flum DR, Khan TV, Dellinger EP. Toward the rational and equitable use of bariatric surgery. JAMA. 2007 Sep 26;298(12):1442-4. — View Citation
Fobi MA, Lee H, Igwe D Jr, Felahy B, James E, Stanczyk M, Tambi J, Eyong P. Revision of failed gastric bypass to distal Roux-en-Y gastric bypass: a review of 65 cases. Obes Surg. 2001 Apr;11(2):190-5. — View Citation
Gianetta E, Friedman D, Adami GF, Vitale B, Traverso E, Castagnola M, Semino G, Scopinaro N. Etiological factors of protein malnutrition after biliopancreatic diversion. Gastroenterol Clin North Am. 1987 Sep;16(3):503-4. — View Citation
Goode LR, Brolin RE, Chowdhury HA, Shapses SA. Bone and gastric bypass surgery: effects of dietary calcium and vitamin D. Obes Res. 2004 Jan;12(1):40-7. — View Citation
Halverson JD. Micronutrient deficiencies after gastric bypass for morbid obesity. Am Surg. 1986 Nov;52(11):594-8. — View Citation
Hamoui N, Anthone G, Crookes PF. Calcium metabolism in the morbidly obese. Obes Surg. 2004 Jan;14(1):9-12. — View Citation
Hamoui N, Kim K, Anthone G, Crookes PF. The significance of elevated levels of parathyroid hormone in patients with morbid obesity before and after bariatric surgery. Arch Surg. 2003 Aug;138(8):891-7. — View Citation
Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA. 2004 Jun 16;291(23):2847-50. — View Citation
Hey H, Stokholm KH, Lund B, Lund B, Sørensen OH. Vitamin D deficiency in obese patients and changes in circulating vitamin D metabolites following jejunoileal bypass. Int J Obes. 1982;6(5):473-9. — View Citation
Higa KD, Boone KB, Ho T, Davies OG. Laparoscopic Roux-en-Y gastric bypass for morbid obesity: technique and preliminary results of our first 400 patients. Arch Surg. 2000 Sep;135(9):1029-33; discussion 1033-4. — View Citation
http://www.asbs.org/htm/Private/resolution.html. American Society of Metabolic and Bariatric Surgeons.
Johnson JM, Maher JW, DeMaria EJ, Downs RW, Wolfe LG, Kellum JM. The long-term effects of gastric bypass on vitamin D metabolism. Ann Surg. 2006 May;243(5):701-4; discussion 704-5. — View Citation
Johnson JM, Maher JW, Samuel I, Heitshusen D, Doherty C, Downs RW. Effects of gastric bypass procedures on bone mineral density, calcium, parathyroid hormone, and vitamin D. J Gastrointest Surg. 2005 Nov;9(8):1106-10; discussion 1110-1. — View Citation
Kushner R. Managing the obese patient after bariatric surgery: a case report of severe malnutrition and review of the literature. JPEN J Parenter Enteral Nutr. 2000 Mar-Apr;24(2):126-32. Review. — View Citation
Liel Y, Ulmer E, Shary J, Hollis BW, Bell NH. Low circulating vitamin D in obesity. Calcif Tissue Int. 1988 Oct;43(4):199-201. — View Citation
Marceau P, Biron S, Lebel S, Marceau S, Hould FS, Simard S, Dumont M, Fitzpatrick LA. Does bone change after biliopancreatic diversion? J Gastrointest Surg. 2002 Sep-Oct;6(5):690-8. — View Citation
Marceau P, Hould FS, Lebel S, Marceau S, Biron S. Malabsorptive obesity surgery. Surg Clin North Am. 2001 Oct;81(5):1113-27. Review. — View Citation
Marcuard SP, Sinar DR, Swanson MS, Silverman JF, Levine JS. Absence of luminal intrinsic factor after gastric bypass surgery for morbid obesity. Dig Dis Sci. 1989 Aug;34(8):1238-42. — View Citation
Mazess RB, Barden HS, Drinka PJ, Bauwens SF, Orwoll ES, Bell NH. Influence of age and body weight on spine and femur bone mineral density in U.S. white men. J Bone Miner Res. 1990 Jun;5(6):645-52. — View Citation
McTigue KM, Harris R, Hemphill B, Lux L, Sutton S, Bunton AJ, Lohr KN. Screening and interventions for obesity in adults: summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2003 Dec 2;139(11):933-49. — View Citation
Mechanick JI, Kushner RF, Sugerman HJ, Gonzalez-Campoy JM, Collazo-Clavell ML, Guven S, Spitz AF, Apovian CM, Livingston EH, Brolin R, Sarwer DB, Anderson WA, Dixon J. American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery Medical Guidelines for Clinical Practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient. Surg Obes Relat Dis. 2008 Sep-Oct;4(5 Suppl):S109-84. doi: 10.1016/j.soard.2008.08.009. Epub 2008 Aug 19. Erratum in: Surg Obes Relat Dis. 2010 Jan-Feb;6(1):112. — View Citation
Meguid MM, Glade MJ, Middleton FA. Weight regain after Roux-en-Y: a significant 20% complication related to PYY. Nutrition. 2008 Sep;24(9):832-42. doi: 10.1016/j.nut.2008.06.027. Review. — View Citation
Moize V, Geliebter A, Gluck ME, Yahav E, Lorence M, Colarusso T, Drake V, Flancbaum L. Obese patients have inadequate protein intake related to protein intolerance up to 1 year following Roux-en-Y gastric bypass. Obes Surg. 2003 Feb;13(1):23-8. — View Citation
Newbury L, Dolan K, Hatzifotis M, Low N, Fielding G. Calcium and vitamin D depletion and elevated parathyroid hormone following biliopancreatic diversion. Obes Surg. 2003 Dec;13(6):893-5. — View Citation
Nguyen NT. Reoperations and revisions in bariatric surgery. Surg Endosc. 2007 Nov;21(11):1907-8. Epub 2007 Sep 8. — View Citation
Ocón Bretón J, Pérez Naranjo S, Gimeno Laborda S, Benito Ruesca P, García Hernández R. [Effectiveness and complications of bariatric surgery in the treatment of morbid obesity]. Nutr Hosp. 2005 Nov-Dec;20(6):409-14. Spanish. — View Citation
Parfitt AM, Pødenphant J, Villanueva AR, Frame B. Metabolic bone disease with and without osteomalacia after intestinal bypass surgery: a bone histomorphometric study. Bone. 1985;6(4):211-20. — View Citation
Ponsky TA, Brody F, Pucci E. Alterations in gastrointestinal physiology after Roux-en-Y gastric bypass. J Am Coll Surg. 2005 Jul;201(1):125-31. Review. — View Citation
Ren CJ. (2004). Laparoscopic malabsorption procedures: Complications. In Laparoscopic Bariatric Surgery (pp. 343-53). Philadelphia: Lippincott Williams & Wilkins.
Rhode BM, Tamin H, Gilfix BM, Sampalis JS, Nohr C, MacLean LD. Treatment of Vitamin B12 Deficiency after Gastric Surgery for Severe Obesity. Obes Surg. 1995 May;5(2):154-158. — View Citation
Riedt CS, Brolin RE, Sherrell RM, Field MP, Shapses SA. True fractional calcium absorption is decreased after Roux-en-Y gastric bypass surgery. Obesity (Silver Spring). 2006 Nov;14(11):1940-8. — View Citation
Santry HP, Gillen DL, Lauderdale DS. Trends in bariatric surgical procedures. JAMA. 2005 Oct 19;294(15):1909-17. — View Citation
Scopinaro N, Gianetta E, Civalleri D, Bonalumi U, Bachi V. Bilio-pancreatic bypass for obesity: 1. An experimental study in dogs. Br J Surg. 1979 Sep;66(9):613-7. — View Citation
Scopinaro N, Gianetta E, Civalleri D, Bonalumi U, Bachi V. Bilio-pancreatic bypass for obesity: II. Initial experience in man. Br J Surg. 1979 Sep;66(9):618-20. — View Citation
Scopinaro N, Gianetta E, Friedman D, Adami GF, Traverso E, Vitale B, Castagnola M, Semino G, Summa M, Bachi V. Surgical revision of biliopancreatic diversion. Gastroenterol Clin North Am. 1987 Sep;16(3):529-31. — View Citation
Scopinaro N, Marinari G, Camerini G, Papadia F; 2004 ABS Consensus Conference. Biliopancreatic diversion for obesity: state of the art. Surg Obes Relat Dis. 2005 May-Jun;1(3):317-28. — View Citation
Scopinaro N, Marinari GM, Pretolesi F, Papadia F, Murelli F, Marini P, Adami GF. Energy and nitrogen absorption after biliopancreatic diversion. Obes Surg. 2000 Oct;10(5):436-41. — View Citation
Scopinaro N, Papadia F, Marinari G, et al. (2007). Biliopancreatic diversion. In Surgical Management of Obesity (pp.239-51). Philadelphia: Saunders.
Scopinaro N. (2008). Biliopancreatic diversion: Revisional surgery. In obesity Surgery Principles and Practice (pp.277-83). New York: McGraw Hill.
Scopinaro N. Biliopancreatic diversion: mechanisms of action and long-term results. Obes Surg. 2006 Jun;16(6):683-9. — View Citation
Sjöström L, Narbro K, Sjöström CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lönroth H, Näslund I, Olbers T, Stenlöf K, Torgerson J, Agren G, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007 Aug 23;357(8):741-52. — View Citation
Skroubis G, Sakellaropoulos G, Pouggouras K, Mead N, Nikiforidis G, Kalfarentzos F. Comparison of nutritional deficiencies after Roux-en-Y gastric bypass and after biliopancreatic diversion with Roux-en-Y gastric bypass. Obes Surg. 2002 Aug;12(4):551-8. — View Citation
Slater GH, Ren CJ, Siegel N, Williams T, Barr D, Wolfe B, Dolan K, Fielding GA. Serum fat-soluble vitamin deficiency and abnormal calcium metabolism after malabsorptive bariatric surgery. J Gastrointest Surg. 2004 Jan;8(1):48-55; discussion 54-5. — View Citation
Sugerman HJ, Kellum JM, DeMaria EJ. Conversion of proximal to distal gastric bypass for failed gastric bypass for superobesity. J Gastrointest Surg. 1997 Nov-Dec;1(6):517-24; discussion 524-6. — View Citation
Van Loan MD, Johnson HL, Barbieri TF. Effect of weight loss on bone mineral content and bone mineral density in obese women. Am J Clin Nutr. 1998 Apr;67(4):734-8. — View Citation
White S, Brooks E, Jurikova L, Stubbs RS. Long-term outcomes after gastric bypass. Obes Surg. 2005 Feb;15(2):155-63. — View Citation
Ybarra J, Sánchez-Hernández J, Gich I, De Leiva A, Rius X, Rodríguez-Espinosa J, Pérez A. Unchanged hypovitaminosis D and secondary hyperparathyroidism in morbid obesity after bariatric surgery. Obes Surg. 2005 Mar;15(3):330-5. — View Citation
Youssef Y, Richards WO, Sekhar N, Kaiser J, Spagnoli A, Abumrad N, Torquati A. Risk of secondary hyperparathyroidism after laparoscopic gastric bypass surgery in obese women. Surg Endosc. 2007 Aug;21(8):1393-6. Epub 2007 Feb 21. — View Citation
* Note: There are 71 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Morbidity and mortality | at discharge, 1 week, 3 weeks, 8 weeks, 3 months, 6 months, 1 year and annually thereafter for up to 8 years | Yes | |
Primary | Weight loss expressed as Body Mass Index and Percentage of excess weight loss | at 6 months, 1 year and annually thereafter for up to 8 years | No | |
Secondary | Trend in comorbidities | at 6 months, 1 year, and annually thereafter for up to 8 years | No | |
Secondary | Symptom resolution | at 6 months, 1 year, and annually thereafter for up to 8 years | No | |
Secondary | Length of operative time which is defined as the time duration of operation measured in minutes from the first skin incision to the final closure of the skin incision | It is measured in minutes from the first skin incision to the final closure of the skin incision at the time of revisional surgery under study. It is a transoperative measure of outcome of the surgery under study | Yes | |
Secondary | Length of Hospital Stay which is a measured of surgical recovery quantified and reported in days. It is a hospital pre-discharge traditional measure of outcome | It is measured in days from the admission date to the discharge date for the hospitalization pertaining to revisional surgery under study | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05502445 -
The Nutritionist's Educational Intervention on the Protein Intake in Hospitalized Elderly People
|
N/A | |
Completed |
NCT02001636 -
Effect of Protein Supplementation After Bariatric Surgery
|
N/A | |
Active, not recruiting |
NCT04565314 -
ELICIT 2.0: Pilot Study of the Effect of Maternal Protein Supplementation During Lactation on Childhood Growth
|
N/A | |
Completed |
NCT03140696 -
Formative Research Study to Address Protein Intake in Children and Analysis of Breast Milk Nutrient Content in Mothers
|
N/A | |
Completed |
NCT04791774 -
Protein-bound Versus Free Amino Acid Nutrition During INtestinal Malabsorption in Critical Illness
|
N/A | |
Recruiting |
NCT06403137 -
Plant Protein Blend and Milk Protein Supplements in Older Individuals
|
N/A | |
Completed |
NCT04587076 -
Evaluation of Protein Intake and Micronutrient Supplementation After Bariatric Surgery
|
||
Not yet recruiting |
NCT06458387 -
Comparison of Clinical Outcomes According to High-protein Provision in Critically Ill Patients After Abdominal Surgery
|
N/A | |
Completed |
NCT03181178 -
Effect of a Complementary Food Supplement on Growth and Morbidity of Ghanaian Infants
|
N/A | |
Completed |
NCT01040533 -
Laparoscopic Revision of Jejunoileal Bypass to Gastric Bypass
|
N/A | |
Not yet recruiting |
NCT05647135 -
ImpACt of Very High Protein Content Enteral nUtrition Formulas on Critically Ill MUltipLe trAuma paTiEnts
|
||
Recruiting |
NCT03947710 -
Effect of Protein Intake During Hemodialysis on Blood Pressure and Arterial Stiffness Indices
|
N/A | |
Completed |
NCT03032237 -
Increase Protein Intake of Older Meal Service Clients With Readymade Protein-rich Meals and Foods
|
N/A |