Laparoscopic Revision Gastric Bypass for Weight Recidivism

Clinically Severe Obesity Clinical Trial

— WR  

Official title:

Laparoscopic Revision Gastric Bypass Surgery for Weight Recidivism: Our Experience in 170 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01040572
• Other study ID #: CMC IRB No. 2009078
• Secondary ID: U1111-1113-0216
• Status: Completed
• Phase: N/A
• First received: December 23, 2009
• Last updated: December 26, 2009
• Start date: October 2009
• Est. completion date: December 2009

Study information

• Verified date: October 2009
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The main aim of this study is to analyze and report traditional, patient-centered, and composite intermediate-term outcomes after laparoscopic revision Roux-en-Y gastric bypass surgery for weight recidivism.

Description:

There is lack of standardization of primary and revisional bariatric surgery compounded by a scant long-term outcome data. The treatment of inadequate weight loss, weight recidivism, and most severe technical complications after primary bariatric surgery remains refractory to non-operative treatment. Failure rates have been reported up to 20% and 35% for the morbidly obese (MO) and super obese (SO), respectively at 2 to 3 years after surgery. The indication for further surgical intervention remains controversial, as does what type of revisional procedure, both operative and endoscopic, to recommend. Furthermore, there is no standardization of the limb lengths, pouch size or the use of prosthetic reinforcement. Therefore the approach to these patients must be as individualized as their original operations. We formally analyze our experience with all laparoscopic revisional strategies for weigh regain after failed gastric bypass.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• 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 that underwent laparoscopic revisional "RYGB" for failed "RYGB" with weight recidivism or weight regain "WR" pattern

Exclusion Criteria:

• failed RYGB with an Inadequate Initial Weight Loss "IIWL" pattern

• patients with prior major bariatric conversion or esophago-gastric surgeries

• RYGB patients revised by an open surgical approach

• RYGB patients who underwent laparoscopic revisional RYGB surgery somewhere else and continue their follow-up care with our program

• missing records and/or unreachable patients with scant information for analysis

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Body Weight
• Clinically Severe Obesity
• Obesity
• Obesity Recidivism
• Obesity, Morbid
• Weight Recidivism
• Weight Regain

Locations

Country	Name	City	State
United States	UCSF Fresno Center for Medical Education and Research	Fresno	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (59)

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

Bessler M, Daud A, DiGiorgi MF, Olivero-Rivera L, Davis D. Adjustable gastric banding as a revisional bariatric procedure after failed gastric bypass. Obes Surg. 2005 Nov-Dec;15(10):1443-8. — View Citation

Bessler M, Daud A, Kim T, DiGiorgi M. Prospective randomized trial of banded versus nonbanded gastric bypass for the super obese: early results. Surg Obes Relat Dis. 2007 Jul-Aug;3(4):480-4; discussion 484-5. Epub 2007 Jun 4. — View Citation

Brolin RE, Cody RP. Adding malabsorption for weight loss failure after gastric bypass. Surg Endosc. 2007 Nov;21(11):1924-6. Epub 2007 Sep 3. — View Citation

Brolin RE, Kenler HA, Gorman JH, Cody RP. Long-limb gastric bypass in the superobese. A prospective randomized study. Ann Surg. 1992 Apr;215(4):387-95. — View Citation

Bruder SJ, Freeman JB, Brazeau-Gravelle P. Lengthening the Roux-Y Limb Increases Weight Loss after Gastric Bypass: a preliminary report. Obes Surg. 1991 Mar;1(1):73-77. — 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

Calle EE, Thun MJ, Petrelli JM, Rodriguez C, Heath CW Jr. Body-mass index and mortality in a prospective cohort of U.S. adults. N Engl J Med. 1999 Oct 7;341(15):1097-105. — View Citation

Capella JF, Capella RF. An assessment of vertical banded gastroplasty-Roux-en-Y gastric bypass for the treatment of morbid obesity. Am J Surg. 2002 Feb;183(2):117-23. — View Citation

Chin PL, Ali M, Francis K, LePort PC. Adjustable gastric band placed around gastric bypass pouch as revision operation for failed gastric bypass. Surg Obes Relat Dis. 2009 Jan-Feb;5(1):38-42. doi: 10.1016/j.soard.2008.08.012. Epub 2008 Aug 22. — View Citation

Choban PS, Flancbaum L. The effect of Roux limb lengths on outcome after Roux-en-Y gastric bypass: a prospective, randomized clinical trial. Obes Surg. 2002 Aug;12(4):540-5. — 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

Ciovica R, Takata M, Vittinghoff E, Lin F, Posselt AM, Rabl C, Stein HJ, Campos GM. The impact of roux limb length on weight loss after gastric bypass. Obes Surg. 2008 Jan;18(1):5-10. Epub 2007 Dec 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

Dapri G, Cadière GB, Himpens J. Laparoscopic placement of non-adjustable silicone ring for weight regain after Roux-en-Y gastric bypass. Obes Surg. 2009 May;19(5):650-4. doi: 10.1007/s11695-009-9807-9. Epub 2009 Mar 5. — View Citation

Deitel M, Greenstein RJ. Recommendations for reporting weight loss. Obes Surg. 2003 Apr;13(2):159-60. — View Citation

Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. — 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

Fedenko V, Evdoshenko V. Antireflux sleeve gastroplasty: description of a novel technique. Obes Surg. 2007 Jun;17(6):820-4. Erratum in: Obes Surg. 2007 Jul;17(7):996. — View Citation

Feng JJ, Gagner M, Pomp A, Korgaonkar NM, Jacob BP, Chu CA, Voellinger DC, Quinn T, Herron DM, Inabnet WB. Effect of standard vs extended Roux limb length on weight loss outcomes after laparoscopic Roux-en-Y gastric bypass. Surg Endosc. 2003 Jul;17(7):1055-60. Epub 2003 May 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, Lee H, Felahy B, Che K, Ako P, Fobi N. Choosing an operation for weight control, and the transected banded gastric bypass. Obes Surg. 2005 Jan;15(1):114-21. Review. — 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

Fox SR, Fox KS, Oh KH. The Gastric Bypass for Failed Bariatric Surgical Procedures. Obes Surg. 1996 Apr;6(2):145-150. — View Citation

Freeman JB, Kotlarewsky M, Phoenix C. Weight loss after extended gastric bypass. Obes Surg. 1997 Aug;7(4):337-44. — View Citation

Gobble RM, Parikh MS, Greives MR, Ren CJ, Fielding GA. Gastric banding as a salvage procedure for patients with weight loss failure after Roux-en-Y gastric bypass. Surg Endosc. 2008 Apr;22(4):1019-22. Epub 2007 Oct 18. — 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

Inabnet WB, Quinn T, Gagner M, Urban M, Pomp A. Laparoscopic Roux-en-Y gastric bypass in patients with BMI <50: a prospective randomized trial comparing short and long limb lengths. Obes Surg. 2005 Jan;15(1):51-7. — View Citation

Khaitan L, Van Sickle K, Gonzalez R, Lin E, Ramshaw B, Smith CD. Laparoscopic revision of bariatric procedures: is it feasible? Am Surg. 2005 Jan;71(1):6-10; discussion 10-2. — 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

Lee S, Sahagian KG, Schriver JP. Relationship between varying Roux limb lengths and weight loss in gastric bypass. Curr Surg. 2006 Jul-Aug;63(4):259-63. — View Citation

MacLean LD, Rhode BM, Nohr CW. Long- or short-limb gastric bypass? J Gastrointest Surg. 2001 Sep-Oct;5(5):525-30. — View Citation

Madan AK, Tichansky DS, Phillips JC. Does pouch size matter? Obes Surg. 2007 Mar;17(3):317-20. — View Citation

Majani G, Pierobon A, Giardini A, et al. Satisfaction Profile (SAT-P) in 732 patients: focus on subjectivity in HRQoL assessment. Psychol Health 2000;15:409-22.

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

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

Mikami D, Needleman B, Narula V, Durant J, Melvin WS. Natural orifice surgery: initial US experience utilizing the StomaphyX device to reduce gastric pouches after Roux-en-Y gastric bypass. Surg Endosc. 2010 Jan;24(1):223-8. doi: 10.1007/s00464-009-0640-y. Epub 2009 Jul 25. — View Citation

Mouiel J, Bourg S, Iannelli A, et al. Nouvelle technique de gastroplatie verticale calibree type Mason-MacLean aveccure de reflux gastro-oesophagien. Jornal de Coelio Chirurgie 2001; 38: 53-6.

Müller MK, Wildi S, Scholz T, Clavien PA, Weber M. Laparoscopic pouch resizing and redo of gastro-jejunal anastomosis for pouch dilatation following gastric bypass. Obes Surg. 2005 Sep;15(8):1089-95. — 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

Oria HE, Moorehead MK. Updated Bariatric Analysis and Reporting Outcome System (BAROS). Surg Obes Relat Dis. 2009 Jan-Feb;5(1):60-6. doi: 10.1016/j.soard.2008.10.004. Epub 2008 Nov 1. — View Citation

Pareja JC, Pilla VF, Callejas-Neto F, Coelho-Neto Jde S, Chaim EA, Magro DO. [Gastric bypass Roux-en-Y gastrojejunostomy--conversion to distal gastrojejunoileostomy for weight loss failure--experience in 41 patients]. Arq Gastroenterol. 2005 Oct-Dec;42(4):196-200. Epub 2006 Jan 19. Portuguese. — View Citation

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. — 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

Roberts K, Duffy A, Kaufman J, Burrell M, Dziura J, Bell R. Size matters: gastric pouch size correlates with weight loss after laparoscopic Roux-en-Y gastric bypass. Surg Endosc. 2007 Aug;21(8):1397-402. Epub 2007 Mar 1. — 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, Wood MH, Sapala MA, Schuhknecht MP, Flake TM Jr. The micropouch gastric bypass: technical considerations in primary and revisionary operations. Obes Surg. 2001 Feb;11(1):3-17. — View Citation

Sarr MG. Reoperative bariatric surgery. Surg Endosc. 2007 Nov;21(11):1909-13. Epub 2007 Aug 19. Review. — View Citation

Schwartz RW, Strodel WE, Simpson WS, Griffen WO Jr. Gastric bypass revision: lessons learned from 920 cases. Surgery. 1988 Oct;104(4):806-12. Review. — 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

Spaulding L, Osler T, Patlak J. Long-term results of sclerotherapy for dilated gastrojejunostomy after gastric bypass. Surg Obes Relat Dis. 2007 Nov-Dec;3(6):623-6. Epub 2007 Oct 23. — 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

Torres JC. Why I Prefer Gastric Bypass Distal Roux-en-Y Gastroileostomy. Obes Surg. 1991 Jun;1(2):189-194. — 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

www.asbs.org/htm/Private/resolution.html. American Society for Metabolic and Bariatric Surgery.

Z'graggen K, Guweidhi A, Steffen R, Potoczna N, Biral R, Walther F, Komminoth P, Horber F. Severe recurrent hypoglycemia after gastric bypass surgery. Obes Surg. 2008 Aug;18(8):981-8. doi: 10.1007/s11695-008-9480-4. Epub 2008 Apr 26. — View Citation

* Note: There are 59 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss expressed as Body Mass Index and Percentage Excess Weight Loss		At the lowest weight loss point and at last follow-up	No
Primary	Comorbidity status		throughout follow-up	No
Primary	Subjective Satisfaction		at last follow-up	No
Primary	Health-Related Quality of Life (HR-QoL).		at the last follow-up	No
Primary	Morbidity and mortality		throughout follow-up	Yes
Secondary	To assess failures		at yearly intervals throughout follow-up	No
Secondary	To evaluate the patients´ metabolic and nutritional status		throughout follow-up	Yes

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