Laparoscopic Revision of Vertical Banded Gastroplasty to Gastric Bypass

NCT01041131 | Completed DMC

• 2 other identifiers: CMC IRB No. 2009073U1111-1113-0085
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Clinically Severe Obesity; Inadequate Weight Loss; Obesity Recidivism

Keywords

Obesity; Obesity recidivism; Inadequate Initial Weight Loss; Technical bariatric complications; Complicated gastroplasty; Failed gastroplasty; Gastroesophageal reflux disease; Revisional gastric bypass; Conversion bariatric surgery; Re-operative bariatric surgery; Technical complications of vertical gastroplasty; Complicated vertical gastroplasty

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Remission or improvement of symptoms

  at 6 months, 1 year and annually thereafter for up to 8 years

Secondary Outcomes (3)

• 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

• Remission or improvement of comorbidities

  at 6 months, 1 year, and annually thereafter for up to 8 years

• 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.

Study Arms (1)

Failed and/or Complicated VBG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients status post failed and/or complicated Vertical Banded Gastroplasty (VBG) undergoing conversion to laparoscopic Roux-en-Y gastric bypass (RYGB)

You may qualify if:

• Patients status post failed and/or complicated VBG undergoing laparoscopic revisional RYGB

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Fresno Center for Medical Education and Research

Fresno, California, 93701, United States

Location

Related Publications (40)

• 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.

  PMID: 10982506 BACKGROUND

• 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.

  PMID: 15199035 BACKGROUND

• 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.

  PMID: 15479938 BACKGROUND

• 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.

  PMID: 15319713 BACKGROUND

• 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.

  PMID: 17715409 BACKGROUND

• 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.

  PMID: 17715408 BACKGROUND

• 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.

  PMID: 18778174 BACKGROUND

• 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.

  PMID: 16234497 BACKGROUND

• 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.

  PMID: 17895461 BACKGROUND

• 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.

  PMID: 18725080 BACKGROUND

• 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.

  PMID: 17828427 BACKGROUND

• ASMBS www.asbs.org/htm/Private/resolution.html

  BACKGROUND

• 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. doi: 10.1381/096089206778026316.

  PMID: 16901357 BACKGROUND

• 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. doi: 10.1097/00000658-199509000-00011.

  PMID: 7677463 BACKGROUND

• 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. doi: 10.1097/01.sla.0000217592.04061.d5.

  PMID: 17060766 BACKGROUND

• Mason EE. Vertical banded gastroplasty for obesity. Arch Surg. 1982 May;117(5):701-6. doi: 10.1001/archsurg.1982.01380290147026.

  PMID: 7073493 BACKGROUND

• 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. doi: 10.1016/0002-9610(84)90465-3.

  PMID: 6383098 BACKGROUND

• 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. doi: 10.1381/096089298765555006.

  PMID: 9562482 BACKGROUND

• 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. doi: 10.1381/096089201321454132.

  PMID: 11361171 BACKGROUND

• 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. doi: 10.1381/09608920160558678.

  PMID: 11775571 BACKGROUND

• 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. doi: 10.1007/s00464-002-8643-y. Epub 2003 Nov 21.

  PMID: 14625748 BACKGROUND

• 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.

  PMID: 19562420 BACKGROUND

• 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. doi: 10.1381/0960892042387066.

  PMID: 15527632 BACKGROUND

• 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. doi: 10.1097/00000658-198706000-00002.

  PMID: 3296971 BACKGROUND

• 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. doi: 10.1016/0002-9610(89)90427-3.

  PMID: 2910132 BACKGROUND

• 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. doi: 10.1097/00000658-199004000-00007.

  PMID: 2181950 BACKGROUND

• Fobi MA. Vertical Banded Gastroplasty vs Gastric Bypass: 10 years follow-up. Obes Surg. 1993 May;3(2):161-164. doi: 10.1381/096089293765559511.

  PMID: 10757913 BACKGROUND

• 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. doi: 10.1381/096089293765559115.

  PMID: 10757953 BACKGROUND

• 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. doi: 10.1016/S0002-9610(97)89565-7.

  PMID: 8619465 BACKGROUND

• Capella RF, Capella JF. Converting vertical banded gastroplasty to a lesser curvature gastric bypass: technical considerations. Obes Surg. 1998 Apr;8(2):218-24. doi: 10.1381/096089298765554854.

  PMID: 9730398 BACKGROUND

• 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. doi: 10.1016/j.surg.2004.05.055.

  PMID: 15467656 BACKGROUND

• 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. doi: 10.1016/j.jamcollsurg.2005.04.022.

  PMID: 16125069 BACKGROUND

• Van Dielen FM, Stevens D, Zoete JP, et al. Results after gastric bypass as revisional surgery. Obes Surg 2007;17:1055.

  BACKGROUND

• 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. doi: 10.1007/s11695-007-9106-2.

  PMID: 17658021 BACKGROUND

• 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. doi: 10.1007/s004640000347. Epub 2001 Feb 6.

  PMID: 11395822 BACKGROUND

• 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. doi: 10.1381/096089202762552737.

  PMID: 11975224 BACKGROUND

• 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.

  BACKGROUND

• 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. doi: 10.1381/0960892053576785.

  PMID: 15826463 BACKGROUND

• 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.

  BACKGROUND

• 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. doi: 10.1007/s00464-007-9576-2. Epub 2007 Oct 18.

  PMID: 17943380 BACKGROUND

Related Links

• "Click here for more information about the department sponsor´s web site"

MeSH Terms

Conditions

Obesity; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Francisco M Tercero, MD

  Research Associate, University of California San Francisco

  STUDY DIRECTOR

• Kelvin D Higa, MD

  Professor of Surgery, University of California San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 26, 2009
• First Posted: December 31, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 1, 2010

Record last verified: 2009-12

Locations

US (1)