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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01040377
Other study ID # CMC IRB No. 2009077
Secondary ID U1111-1113-0264
Status Completed
Phase N/A
First received December 23, 2009
Last updated December 28, 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 inadequate initial weight loss.


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 Inadequate Initial Weight Loss after failed Roux-en-Y gastric bypass(RYGB).


Recruitment information / eligibility

Status Completed
Enrollment 42
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:

- laparoscopic revisional RYGB for failed RYGB with IIWL or non-responders pattern

Exclusion Criteria:

- failed RYGB with a WR 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 program

- missing records and/or unreachable patients with scan information for analysis

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


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)

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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

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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

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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

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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

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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

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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

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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

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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 avec cure 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

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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

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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 allClick 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 Health-related Quality of Life (HR-QoL) at last follow-up No
Primary Subjective satisfaction at the last follow-up No
Primary Morbidity and mortality throughout follow-up Yes
Secondary Failure/success rate at yearly intervals throughout follow-up No
Secondary Metabolic and nutritional variables throughout follow-up Yes
See also
  Status Clinical Trial Phase
Completed NCT01040533 - Laparoscopic Revision of Jejunoileal Bypass to Gastric Bypass N/A
Completed NCT01040481 - Adding Malabsorption for Failed Gastric Bypass N/A