Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss (IIWL)
28 dicembre 2009 aggiornato da: University of California, San Francisco
Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss After Gastric Bypass: Intermediate Results
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.
Panoramica dello studio
Stato
Completato
Descrizione dettagliata
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).
Tipo di studio
Osservativo
Iscrizione (Effettivo)
42
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
California
-
Fresno, California, Stati Uniti, 93701
- UCSF Fresno Center for Medical Education and Research
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Patients that underwent laparoscopic revision gastric bypass after previously failed Roux-en-Y gastric bypass "RYGB" with an Inadequate initial weight loss "IIWL" pattern.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
Inadequate initial weight loss after gastric bypass
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Morbilità e mortalità
Lasso di tempo: durante tutto il follow-up
|
durante tutto il follow-up
|
|
Qualità della vita correlata alla salute (HR-QoL)
Lasso di tempo: all'ultimo follow-up
|
all'ultimo follow-up
|
|
Stato di comorbidità
Lasso di tempo: durante tutto il follow-up
|
durante tutto il follow-up
|
|
Subjective satisfaction
Lasso di tempo: at the last follow-up
|
at the last follow-up
|
|
Weight loss expressed as Body Mass Index and Percentage excess weight loss
Lasso di tempo: at the lowest weight loss point and at last follow-up
|
at the lowest weight loss point and at last follow-up
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Failure/success rate
Lasso di tempo: at yearly intervals throughout follow-up
|
at yearly intervals throughout follow-up
|
|
Metabolic and nutritional variables
Lasso di tempo: throughout follow-up
|
throughout follow-up
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Kelvin D Higa, MD, Professor of Surgery, University of California San Francisco
- Direttore dello studio: Francisco M Tercero, MD, Research Associate, University of California San Franisco
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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. doi: 10.1097/01.sla.0000133083.54934.ae.
- 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. Erratum In: JAMA. 2005 Apr 13;293(14):1728.
- 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.
- 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.
- 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.
- 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.
- 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. doi: 10.1056/NEJM199910073411501.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. doi: 10.1097/00000658-199204000-00014.
- MacLean LD, Rhode BM, Nohr CW. Long- or short-limb gastric bypass? J Gastrointest Surg. 2001 Sep-Oct;5(5):525-30. doi: 10.1016/s1091-255x(01)80091-3.
- 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. doi: 10.1381/096089202762252316.
- 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. doi: 10.1016/j.cursur.2006.05.001.
- 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. doi: 10.1007/s11695-007-9312-y. Epub 2007 Dec 7.
- 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. doi: 10.1381/096089291765561501.
- Freeman JB, Kotlarewsky M, Phoenix C. Weight loss after extended gastric bypass. Obes Surg. 1997 Aug;7(4):337-44. doi: 10.1381/096089297765555593.
- 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. doi: 10.1007/s00464-002-8933-4. Epub 2003 May 6.
- 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. doi: 10.1381/0960892052993468.
- Torres JC. Why I Prefer Gastric Bypass Distal Roux-en-Y Gastroileostomy. Obes Surg. 1991 Jun;1(2):189-194. doi: 10.1381/096089291765561268.
- Fox SR, Fox KS, Oh KH. The Gastric Bypass for Failed Bariatric Surgical Procedures. Obes Surg. 1996 Apr;6(2):145-150. doi: 10.1381/096089296765557097.
- 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. doi: 10.1016/s1091-255x(97)80067-4.
- 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. doi: 10.1381/096089201321577866.
- 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. doi: 10.1381/096089201321454042.
- Brolin RE, Cody RP. Adding malabsorption for weight loss failure after gastric bypass. Surg Endosc. 2007 Nov;21(11):1924-6. doi: 10.1007/s00464-007-9542-z. Epub 2007 Sep 3.
- Sarr MG. Reoperative bariatric surgery. Surg Endosc. 2007 Nov;21(11):1909-13. doi: 10.1007/s00464-007-9536-x. Epub 2007 Aug 19. No abstract available.
- Schwartz RW, Strodel WE, Simpson WS, Griffen WO Jr. Gastric bypass revision: lessons learned from 920 cases. Surgery. 1988 Oct;104(4):806-12.
- 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. doi: 10.1007/s00464-007-9232-x. Epub 2007 Mar 1.
- Madan AK, Tichansky DS, Phillips JC. Does pouch size matter? Obes Surg. 2007 Mar;17(3):317-20. doi: 10.1007/s11695-007-9058-6.
- Muller 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. doi: 10.1381/0960892055002257.
- 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. doi: 10.1381/0960892052993404.
- 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. doi: 10.1016/s0002-9610(01)00871-6.
- White S, Brooks E, Jurikova L, Stubbs RS. Long-term outcomes after gastric bypass. Obes Surg. 2005 Feb;15(2):155-63. doi: 10.1381/0960892053268282.
- 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. doi: 10.1016/j.soard.2007.01.010. Epub 2007 Jun 4.
- 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.
- Dapri G, Cadiere 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.
- 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. doi: 10.1381/096089205774859173.
- 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. doi: 10.1007/s00464-007-9609-x. Epub 2007 Oct 18.
- 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.
- Fedenko V, Evdoshenko V. Antireflux sleeve gastroplasty: description of a novel technique. Obes Surg. 2007 Jun;17(6):820-4. doi: 10.1007/s11695-007-9124-0. Erratum In: Obes Surg. 2007 Jul;17(7):996.
- 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. doi: 10.1381/096089204322857528.
- 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. doi: 10.1016/j.soard.2007.07.009. Epub 2007 Oct 23.
- 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.
- Deitel M, Greenstein RJ. Recommendations for reporting weight loss. Obes Surg. 2003 Apr;13(2):159-60. doi: 10.1381/096089203764467117. No abstract available.
- 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.
- www.asbs.org/htm/Private/resolution.html. American Society of Metabolic and Bariatric Surgery.
- 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.
- Parej JC, Pilla VF, Callejas-Neto F, et al. Gastroplastia reductora com bypass gastrojejunal em Y-de-roux: conversao para bypass gastrointestinal distal por perdida insuficiente de peso - experiencia em 41 pacientes. Art Gatroenterol 20054; 42(4): 196-200.
- 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.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 ottobre 2009
Completamento primario (Effettivo)
1 dicembre 2009
Completamento dello studio (Effettivo)
1 dicembre 2009
Date di iscrizione allo studio
Primo inviato
23 dicembre 2009
Primo inviato che soddisfa i criteri di controllo qualità
28 dicembre 2009
Primo Inserito (Stima)
29 dicembre 2009
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
29 dicembre 2009
Ultimo aggiornamento inviato che soddisfa i criteri QC
28 dicembre 2009
Ultimo verificato
1 ottobre 2009
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CMC IRB No. 2009077
- U1111-1113-0264 (Altro identificatore: World Health Organization, Universal Trial Number)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .