Clinically Severe Obesity Clinical Trial
— VBGOfficial title:
Laparoscopic Revisional Gastric Bypass Surgery for Failed and/or Complicated Open Vertical Banded Gastroplasty: Our Experience With 70 Patients
The main aim of this study is to analyze and report the intermediate term outcomes after
laparoscopic revision Roux-en-Y gastric bypass (RYGB) surgery for failed and/or complicated
Vertical Banded Gastroplasty (VBG). The foremost outcome measurements are 1) Fat loss mainly
measured as weight loss and expressed as trends in BMI, %EWL, and/or %EBL. 2) Trend in
Comorbidity status. 3) Subjective Satisfaction and Health-Related Quality of Life "HR-QoL"
are measured by a standardized, non-validated satisfaction questionnaire and by a validated,
disease-specific worldwide used HR-QoL questionnaire. 4) Morbidity & Mortality include
nutritional status and metabolic complications.
Consequently, secondary objectives of this study are the following. 1) To assess failure
rate defined as percentage of excess weight loss < 50%, lowest BMI >35 for morbidly obese
(MO) or >40 for superobese (SO), and/or lack of resolution/improvement of major
comorbidities at the point in time when assessed at each postoperative year after the
surgery under study. 2) To evaluate the metabolic and nutritional status by measurements of
particular clinical and biochemical parameters.
Status | Completed |
Enrollment | 70 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients status post failed and/or complicated VBG undergoing laparoscopic revisional RYGB Exclusion Criteria: - Patients with prior major conversion, revision, and/or esophago-gastric surgery - Conversion performed by open approach - Conversion performed somewhere else with follow-up by our program |
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
ASMBS www.asbs.org/htm/Private/resolution.html
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
Calmes JM, Giusti V, Suter M. Reoperative laparoscopic Roux-en-Y gastric bypass: an experience with 49 cases. Obes Surg. 2005 Mar;15(3):316-22. — View Citation
Capella RF, Capella JF. Converting vertical banded gastroplasty to a lesser curvature gastric bypass: technical considerations. Obes Surg. 1998 Apr;8(2):218-24. — View Citation
Christou NV, Look D, Maclean LD. Weight gain after short- and long-limb gastric bypass in patients followed for longer than 10 years. Ann Surg. 2006 Nov;244(5):734-40. — 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
Cordera F, Mai JL, Thompson GB, Sarr MG. Unsatisfactory weight loss after vertical banded gastroplasty: is conversion to Roux-en-Y gastric bypass successful? Surgery. 2004 Oct;136(4):731-7. — 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
de Csepel J, Nahouraii R, Gagner M. Laparoscopic gastric bypass as a reoperative bariatric surgery for failed open restrictive procedures. Surg Endosc. 2001 Apr;15(4):393-7. Epub 2001 Feb 6. — 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. Vertical Banded Gastroplasty vs Gastric Bypass: 10 years follow-up. Obes Surg. 1993 May;3(2):161-164. — View Citation
Gagne DJ, Goitein D, Papasavas PK, et al. Laparoscopic revision of vertical banded gastroplasty to Roux-en-Y gastric bypass: an outcome analysis. Obes Surg 2005;1:243.
Gagner M, Gentileschi P, de Csepel J, Kini S, Patterson E, Inabnet WB, Herron D, Pomp A. Laparoscopic reoperative bariatric surgery: experience from 27 consecutive patients. Obes Surg. 2002 Apr;12(2):254-60. — View Citation
Gavert N, Szold A, Abu-Abeid S. Safety and feasibility of revisional laparoscopic surgery for morbid obesity: conversion of open silastic vertical banded gastroplasty to laparoscopic adjustable gastric banding. Surg Endosc. 2004 Feb;18(2):203-6. Epub 2003 Nov 21. — View Citation
Gonzalez R, Gallagher SF, Haines K, Murr MM. Operative technique for converting a failed vertical banded gastroplasty to Roux-en-Y gastric bypass. J Am Coll Surg. 2005 Sep;201(3):366-74. — View Citation
Hall JC, Watts JM, O'Brien PE, Dunstan RE, Walsh JF, Slavotinek AH, Elmslie RG. Gastric surgery for morbid obesity. The Adelaide Study. Ann Surg. 1990 Apr;211(4):419-27. — 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
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
Iannelli A, Schneck AS, Ragot E, Liagre A, Anduze Y, Msika S, Gugenheim J. Laparoscopic sleeve gastrectomy as revisional procedure for failed gastric banding and vertical banded gastroplasty. Obes Surg. 2009 Sep;19(9):1216-20. doi: 10.1007/s11695-009-9903-x. Epub 2009 Jun 27. — View Citation
Keshishian A, Zahriya K, Hartoonian T, Ayagian C. Duodenal switch is a safe operation for patients who have failed other bariatric operations. Obes Surg. 2004 Oct;14(9):1187-92. — View Citation
Kyzer S, Raziel A, Landau O, Matz A, Charuzi I. Use of adjustable silicone gastric banding for revision of failed gastric bariatric operations. Obes Surg. 2001 Feb;11(1):66-9. — View Citation
Mason EE. Vertical banded gastroplasty for obesity. Arch Surg. 1982 May;117(5):701-6. — 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
Nguyen NT. Reoperations and revisions in bariatric surgery. Surg Endosc. 2007 Nov;21(11):1907-8. Epub 2007 Sep 8. — View Citation
O'Brien PE, McPhail T, Chaston TB, Dixon JB. Systematic review of medium-term weight loss after bariatric operations. Obes Surg. 2006 Aug;16(8):1032-40. Review. — View Citation
Pories WJ, Swanson MS, MacDonald KG, Long SB, Morris PG, Brown BM, Barakat HA, deRamon RA, Israel G, Dolezal JM, et al. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg. 1995 Sep;222(3):339-50; discussion 350-2. — View Citation
Santry HP, Gillen DL, Lauderdale DS. Trends in bariatric surgical procedures. JAMA. 2005 Oct 19;294(15):1909-17. — View Citation
Sapala JA, Bolar RJ, Bell JP, Sapala MA. Technical Strategies for Converting the Failed Vertical Banded Gastroplasty to the Roux-en-Y Gastric Bypass. Obes Surg. 1993 Nov;3(4):400-409. — View Citation
Schouten R, van Dielen FM, van Gemert WG, Greve JW. Conversion of vertical banded gastroplasty to Roux-en-Y gastric bypass results in restoration of the positive effect on weight loss and co-morbidities: evaluation of 101 patients. Obes Surg. 2007 May;17(5):622-30. Erratum in: Obes Surg. 2007 Jul;17(7):996. — 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
Sugerman HJ, Kellum JM Jr, DeMaria EJ, Reines HD. Conversion of failed or complicated vertical banded gastroplasty to gastric bypass in morbid obesity. Am J Surg. 1996 Feb;171(2):263-9. — View Citation
Sugerman HJ, Londrey GL, Kellum JM, Wolf L, Liszka T, Engle KM, Birkenhauer R, Starkey JV. Weight loss with vertical banded gastroplasty and Roux-Y gastric bypass for morbid obesity with selective versus random assignment. Am J Surg. 1989 Jan;157(1):93-102. — View Citation
Sugerman HJ, Starkey JV, Birkenhauer R. A randomized prospective trial of gastric bypass versus vertical banded gastroplasty for morbid obesity and their effects on sweets versus non-sweets eaters. Ann Surg. 1987 Jun;205(6):613-24. — View Citation
Sugerman HJ, Wolper JL. Failed gastroplasty for morbid obesity. Revised gastroplasty versus Roux-Y gastric bypass. Am J Surg. 1984 Sep;148(3):331-6. — View Citation
Suter M, Calmes JM, Paroz A, et al. Revisional Roux-en-Y gastric bypass: 8-year experience with 121 patients. Obes Sug 2007;17:1057.
Taskin M, Zengin K, Unal E, Sakoglu N. Conversion of failed vertical banded gastroplasty to open adjustable gastric banding. Obes Surg. 2001 Dec;11(6):731-4. — View Citation
Van Dessel E, Hubens G, Ruppert M, Balliu L, Weyler J, Vaneerdeweg W. Roux-en-Y gastric bypass as a re-do procedure for failed restricive gastric surgery. Surg Endosc. 2008 Apr;22(4):1014-8. Epub 2007 Oct 18. — View Citation
Van Dielen FM, Stevens D, Zoete JP, et al. Results after gastric bypass as revisional surgery. Obes Surg 2007;17:1055.
van Gemert WG, van Wersch MM, Greve JW, Soeters PB. Revisional surgery after failed vertical banded gastroplasty: restoration of vertical banded gastroplasty or conversion to gastric bypass. Obes Surg. 1998 Feb;8(1):21-8. — View Citation
* Note: There are 40 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 excess weight loss | at 6 months, 1 year and annually thereafter for up to 8 years | No | |
Primary | Remission or improvement of symptoms | 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 | No | |
Secondary | Remission or improvement of comorbidities | at 6 months, 1 year, and annually thereafter for up to 8 years | No | |
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 |
NCT01040572 -
Laparoscopic Revision Gastric Bypass for Weight Recidivism
|
N/A | |
Completed |
NCT01040507 -
Very Long Term Results After Laparoscopic Retrocolic Antegastric Gastric Bypass
|
N/A | |
Completed |
NCT01041105 -
Gastric Bypass After Previous Anti-reflux Surgery
|
N/A | |
Completed |
NCT01040533 -
Laparoscopic Revision of Jejunoileal Bypass to Gastric Bypass
|
N/A | |
Completed |
NCT01040481 -
Adding Malabsorption for Failed Gastric Bypass
|
N/A |