NCT01040416|CompletedDMC
Endoscopic Therapy for Bleeding Marginal Ulcers After Gastric Bypass
BleedingMU
Endoscopic Therapy for Actively Bleeding Marginal Ulcers: Our Experience After 7,020 Roux-en-Y Gastric Bypass Surgeries
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BleedingMU
Endoscopic Therapy for Actively Bleeding Marginal Ulcers: Our Experience After 7,020 Roux-en-Y Gastric Bypass Surgeries
Sponsor study identifier
Secondary identifiers
OTHER · World Health Organization, Universal Trial Number
observational
45
1 country
1
Study Start
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)The objective of this study is to identify the incidence rate; describe the risk factors, clinical presentation, and endoscopic treatment; assess the morbidity, mortality, and overall performance of the management of patients with actively bleeding marginal ulcers after Roux-en-Y gastric bypass (RYGB) surgery.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
December 2009
Actual (reported)December 2009
Actual (reported)December 23, 2009
Actual (reported)December 29, 2009
Actual (reported)Morbidity and mortality, overall
throughout follow-up
re-bleeding, gastrointestinal hemorrhage secondary to marginal ulceration
throughout follow-up
marginal ulcer recurrence
at last follow-up
Symptom resolution, marginal ulcer
at last follow-up
consumption of blood products
during bleeding-related hospitalization
weight loss expressed as Body Mass Index and Percentage excess weight loss
at the lowest point and yearly intervals
Patients with actively bleeding marginal ulcers after Roux-en-Y gastric bypass (RYGB) surgery.
UCSF Fresno Center for Medical Education and Research
Fresno, California, 93701, United States
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. doi: 10.1001/archsurg.135.9.1029.
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. doi: 10.1001/jama.291.23.2847.
Francisco M Tercero, MD
Research Associate, University of California San Francisco
Kelvin D Higa, MD
Professor of Surgery, University of California San Francisco
45 participants (actual enrollment reported by the registry).
First Submitted
December 23, 2009
First Posted
December 29, 2009
Study Start
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
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. doi: 10.7326/0003-4819-139-11-200312020-00013.
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. doi: 10.1001/jama.292.14.1724.
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. doi: 10.1097/01.sla.0000137343.63376.19.
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. doi: 10.1056/NEJMoa066603.
Sjostrom L, Narbro K, Sjostrom 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, Lonroth H, Naslund I, Olbers T, Stenlof 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. doi: 10.1056/NEJMoa066254.
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.
Santry HP, Gillen DL, Lauderdale DS. Trends in bariatric surgical procedures. JAMA. 2005 Oct 19;294(15):1909-17. doi: 10.1001/jama.294.15.1909.
Flum DR, Khan TV, Dellinger EP. Toward the rational and equitable use of bariatric surgery. JAMA. 2007 Sep 26;298(12):1442-4. doi: 10.1001/jama.298.12.1442. No abstract available.
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.
Nguyen NT. Reoperations and revisions in bariatric surgery. Surg Endosc. 2007 Nov;21(11):1907-8. doi: 10.1007/s00464-007-9572-6. Epub 2007 Sep 8. No abstract available.
Sapala JA, Wood MH, Sapala MA, Flake TM Jr. Marginal ulcer after gastric bypass: a prospective 3-year study of 173 patients. Obes Surg. 1998 Oct;8(5):505-16. doi: 10.1381/096089298765554061.
Higa KD, Boone KB, Ho T. Complications of the laparoscopic Roux-en-Y gastric bypass: 1,040 patients--what have we learned? Obes Surg. 2000 Dec;10(6):509-13. doi: 10.1381/096089200321593706.
Sanyal AJ, Sugerman HJ, Kellum JM, Engle KM, Wolfe L. Stomal complications of gastric bypass: incidence and outcome of therapy. Am J Gastroenterol. 1992 Sep;87(9):1165-9.
Capella JF, Capella RF. Staple Disruption and Marginal Ulceration in Gastric Bypass Procedures for Weight Reduction. Obes Surg. 1996 Feb;6(1):44-49. doi: 10.1381/096089296765557259.
Capella JF, Capella RF. Gastro-gastric fistulas and marginal ulcers in gastric bypass procedures for weight reduction. Obes Surg. 1999 Feb;9(1):22-7; discussion 28. doi: 10.1381/096089299765553674.
Jordan JH, Hocking MP, Rout WR, Woodward ER. Marginal ulcer following gastric bypass for morbid obesity. Am Surg. 1991 May;57(5):286-8.
Sacks BC, Mattar SG, Qureshi FG, Eid GM, Collins JL, Barinas-Mitchell EJ, Schauer PR, Ramanathan RC. Incidence of marginal ulcers and the use of absorbable anastomotic sutures in laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2006 Jan-Feb;2(1):11-6. doi: 10.1016/j.soard.2005.10.013.
Lublin M, McCoy M, Waldrep DJ. Perforating marginal ulcers after laparoscopic gastric bypass. Surg Endosc. 2006 Jan;20(1):51-4. doi: 10.1007/s00464-005-0325-0. Epub 2005 Dec 7.
St Jean MR, Dunkle-Blatter SE, Petrick AT. Laparoscopic management of perforated marginal ulcer after laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2006 Nov-Dec;2(6):668. doi: 10.1016/j.soard.2006.09.011. No abstract available.
Chin EH, Hazzan D, Sarpel U, Herron DM. Multimedia article. Laparoscopic repair of a perforated marginal ulcer 2 years after gastric bypass. Surg Endosc. 2007 Nov;21(11):2110. doi: 10.1007/s00464-007-9486-3. Epub 2007 Aug 18.
Wheeler AA, de la Torre RA, Fearing NM. Laparoscopic repair of perforated marginal ulcer following Roux-en-Y gastric bypass: a case series. J Laparoendosc Adv Surg Tech A. 2011 Jan-Feb;21(1):57-60. doi: 10.1089/lap.2010.0402. Epub 2011 Jan 19.
Nguyen NT, Hinojosa MW, Gray J, Fayad C. Reoperation for marginal ulceration. Surg Endosc. 2007 Nov;21(11):1919-21. doi: 10.1007/s00464-007-9538-8. Epub 2007 Aug 19. No abstract available.
Patel RA, Brolin RE, Gandhi A. Revisional operations for marginal ulcer after Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2009 May-Jun;5(3):317-22. doi: 10.1016/j.soard.2008.10.011. Epub 2008 Nov 6.
Hata JA, DeMaria EJ, Portenier DD et al. Marginal ulcer after 1,792 laparoscopic Roux-en-Y gastric bypass (LRYGB) procedures: incidence, medical and surgical treatment and complications. Surg Obes Relat Dis 2008; 4(3):308-9 (Abstract).
Madan AK, DeArmond G, Ternovits CA, Beech DJ, Tichansky DS. Laparoscopic revision of the gastrojejunostomy for recurrent bleeding ulcers after past open revision gastric bypass. Obes Surg. 2006 Dec;16(12):1662-8. doi: 10.1381/096089206779319400.
Nguyen NT, Longoria M, Chalifoux S, Wilson SE. Gastrointestinal hemorrhage after laparoscopic gastric bypass. Obes Surg. 2004 Nov-Dec;14(10):1308-12. doi: 10.1381/0960892042583879.
Nguyen NT, Hinojosa MW, Gray J et al. (2008). Gastrointestinal bleeding after Roux-en-Y gastric bypass. In Weight loss surgery: A multidisciplinary approach (pp. 401-4). Edgemont, PA: Matrix Medical Communications.
Braley SC, Nguyen NT, Wolfe BM. Late gastrointestinal hemorrhage after gastric bypass. Obes Surg. 2002 Jun;12(3):404-7. doi: 10.1381/096089202321088255.
Gutthann SP, Garcia Rodriguez LA, Raiford DS. Individual nonsteroidal antiinflammatory drugs and other risk factors for upper gastrointestinal bleeding and perforation. Epidemiology. 1997 Jan;8(1):18-24. doi: 10.1097/00001648-199701000-00003.
Gralnek IM, Barkun AN, Bardou M. Management of acute bleeding from a peptic ulcer. N Engl J Med. 2008 Aug 28;359(9):928-37. doi: 10.1056/NEJMra0706113. No abstract available.
Barkun AN. Should every patient with suspected upper GI bleeding receive a proton pump inhibitor while awaiting endoscopy? Gastrointest Endosc. 2008 Jun;67(7):1064-6. doi: 10.1016/j.gie.2008.02.040. No abstract available.
Fernandez-Esparrach G, Bordas JM, Pellise M, Gimeno-Garcia AZ, Lacy A, Delgado S, Cardenas A, Gines A, Sendino O, Momblan D, Zabalza M, Llach J. Endoscopic management of early GI hemorrhage after laparoscopic gastric bypass. Gastrointest Endosc. 2008 Mar;67(3):552-5. doi: 10.1016/j.gie.2007.10.024.
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)Last Updated
December 29, 2009
Record last verified: 2009-12
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