Gastric Bypass After Previous Anti-reflux Surgery

Gastroesophageal Reflux Disease Clinical Trial

— RYGBafterARS  

Official title:

Laparoscopic Revision Roux-en-Y Gastric Bypass Surgery After Previous Anti-rflux Surgery: Intermediate Results

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01041105
• Other study ID #: CMC IRB No. 2008086
• Secondary ID: U1111-1112-9919
• Status: Completed
• Phase: N/A
• First received: December 26, 2009
• Last updated: December 31, 2009
• Start date: December 2008
• Est. completion date: December 2009

Study information

• Verified date: December 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 goal of this study is to describe the clinical presentation, indications, and operative treatment as well as assess the morbidity, mortality, and overall performance of revisional Roux-en-Y gastric bypass (RYGB) after either failed or functional antireflux surgery "ARS" in obese patients. With such information, we hope to determine which features might assist us in advancing our knowledge about Gastro-Esophageal Reflux Disease "GERD", the best option for primary ARS, and mechanisms of failure in the obese population as well as in identifying predictors of outcome after revisional surgery in this population.

Description:

The epidemic of overweight and obesity in the United States of America along with its comorbidities continues to expand. Bariatric surgery has demonstrated to be the most effective and sustained method to control severe obesity and its comorbidities. For instance, type 2 diabetes mellitus was completely resolved in 76.8 percent, systemic arterial hypertension was resolved in 61.7 percent, dyslipidemia improved in 70 percent, and obstructive sleep apnea-hypopnea syndrome was resolved in 85.7 percent. Furthermore, bariatric surgery significantly increases life expectancy (89 percent) and decreases overall mortality (30-40 percent), particularly deaths from diabetes, heart disease, and cancer. Lastly, preliminary evidence about downstream savings associated with bariatric surgery offset the initial costs in 2 to 4 years.

Since 1998, there has been a substantially progressive increase in bariatric surgery. In 2005, the American Society of Metabolic and Bariatric Surgery "ASMBS" reported that 81 percent of bariatric procedures were approached laparoscopically. 205,000 people, in 2007, had bariatric surgery in the United States from which approximately 80 percent of these were Gastric Bypass. Moreover, there is a mismatch between eligibility and receipt of bariatric surgery with just less than 1 percent of the eligible population being treated for morbid obesity through bariatric surgery. Along with the increasing number of elective primary weight loss procedures, up to 20 percent of post RYGB patients cannot sustain their weight loss beyond 2 to 3 years after the primary bariatric procedure. Thus, revisional surgery for poor weight loss and re-operations for technical or mechanical complications will rise in a parallel manner.

Three systematic reviews and meta-analysis have examined the association between obesity (BMI >30kg/m2) and several GERD-related disorders, including 1) GERD symptoms, 2) erosive esophagitis "EE", and 3) esophageal adenocarcinoma "EA". Obesity is associated with a 1.5-to-2-fold increased risk of GERD symptoms and EE and a 2- to 2.5-fold increased risk of EA. In two large case-control studies, abdominal diameter (waist-hip ratio), but not BMI, is an independent risk factor for another GERD-related disorder, Barrett´s esophagus "BE".

Current pathophysiological mechanisms of GERD in the obese encompass the following. 1) Mechanical: I) increased intra-gastric pressure: increased intra-peritoneal and abdominal wall fat mass increases the intra-abdominal and peri-gastric pressures with subsequent increased gastroesophageal pressure gradient "GEPE" with augmented esophageal acid exposure. Each BMI unit increase corresponds to a 10 percent increase in intra-gastric pressure. II) Hiatal Hernia: "HH" disrupts the integrity of the sphincter mechanisms and prolongs esophageal acid clearance. Thin, normal, overweight, and obese subjects have a 1.0, 1.9, 2.5, and 4.2 risk of having HH compared to thin subjects, respectively. 2) Motility: I) Increased Transient LES Relaxation "TLESR" are associated with acid reflux during the postprandial period, especially during inspiration. II) Low LES basal pressure: Increased prevalence of abnormally low LES basal pressure in the overweight and obese in comparison to the normoweight subject. III) Esophageal motility abnormality: Jaffin et al, with esophageal manometry, reported 61 percent of patients with altered esophageal motility from which 59 percent had altered visceral pain perception (asymptomatic). IV) Delayed gastric emptying: mostly associated with one of its major comorbidities, diabetes mellitus. 3) Esophageal sensitivity: Mercer et al., with a Bernstein test, found a significant difference between normoweight and obese subjects without clinical evidence of GERD (0 percent vs. 86 percent, respectively) for esophageal hypersensitivity. 4) Hormonal: mostly mediated by estrogen and adiponectin. 5) Environmental (Diet): high-fat, saturated fatty acids, high-cholesterol, and high caloric density diets have been associated with the highest likelihood of perceiving an acid reflux event; fat may confer its sensory effect by activating pain facilitatory pathways or by deactivating pain inhibitory pathways.

The most recent data is not conclusive on whether increased BMI affects acid-suppressive therapy for GERD. However, MacDougall et al. found that increased BMI was significantly associated with long-term acid suppression therapy. This can be explained based on either a higher prevalence of factors that predispose overweight and obese subjects to severe GERD, such as HH, greater GEPG, increased number of TLESR, or standard doses of PPI´s are suboptimal for patients with increased BMI and GERD.

Broad indications for antireflux surgery include: 1) Reflux of food associated with HH, 2) despite successful medical treatment or after poor or moderate symptom control on optimized PPI therapy, patient opts for surgery, and 3) Complicated GERD without including severe dysplasia.

Available traditional ARS are either 1) fundoplication, which is the most commonly performed procedure and can be partial -Toupet, Dor- or complete -Nissen-, or other procedures with limited use such as 2) Hill operation, 3) pyloroplasty, 4) vagotomy with antrectomy, and 5) duodenal switch.

Long-term control of typical symptoms after primary laparoscopic Nissen fundoplication "LNF", in properly selected patients and with an experienced surgical team, is attained in more than 90 percent of patients confirming that LNF is the gold standard for the treatment of severe GERD.

In a cohort study of 166 patients followed for 11 years, Smith et al found preoperative response to acid-reducing medication, typical symptoms, and BMI < 35 Kg/m2 to predict successful outcome. However, HH size, normal 24-hour pH score, age > 50 years, female gender, and prior abdominal surgery that previous studies found to be associated with poor outcomes were not corroborated by this study. Other risk factors for failure are short esophagus, HH greater than 3 cm, and diaphragmatic stressors such as retching, sports of weight lifting, and high-speed motor vehicle accident among others.

Another study found increased BMI to be a predictor of poor outcome. Perez et al, in a retrospective cohort analysis of 224 patients undergoing LNF and transthoracic ARS, found a significantly increased recurrence rate of GERD in obese and overweight compared to normoweight patients, regardless of procedure type.

In contrast, a cohort study of 257 consecutive patients undergoing LNF, D´Alessio et al analyzed outcomes based on BMI (< 25, 25-30, and >30 kg/m2); No significant differences in symptom scores and clinical success rates were found among the different subsets. However, mean BMI for obese patients was 33 kg/m2 (obesity class I) and only three patients were >35 kg/m2.

Regardless of contradictory data about LNF efficacy in obesity, several studies have shown the effectiveness of RYGB for GERD in morbidly obese patients by symptoms, endoscopic findings, manometry and pH-metry results, and endoscopic biopsy-histopathology.

There are four retrospective cohort studies assessing mostly early outcomes after converting ARS to RYGB. First, Sarr et al analyzed 19 patients that underwent open conversion to RYGB. Next, Ikramuddin et al described the anatomic findings for fundoplication failure after the laparoscopic conversion to RYGB of 11 patients. Lastly, with seven patients each, Raftopoulos et al and Donnelly et al reported feasibility with a high morbidity rate as well.

In summary, there is little information about what is the best primary ARS and the best revisional strategy to address intractable or severe reflux after failed fundoplication in the obese population. Also, there is lack of data about the best revisional procedure to address obesity in the patient status post functional or competent ARS. With this pilot retrospective study, we will advance our knowledge and along with the existing literature, we will draw preliminary clinical recommendations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Status post, either open or laparoscopic, primary Nissen fundoplication with all the following requirements:

• Met NIH criteria for bariatric surgery

• With functional or failed antireflux surgery (Nissen fundoplication)

• Laparoscopic approach for revisional surgery

Exclusion Criteria:

• Any other type of revisional bariatric procedure

• Nonstandard revisional RYGB surgery

• Open approach for revision surgery

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Clinically Severe Obesity
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Obesity, Morbid

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 (38)

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

Bammer T, Hinder RA, Klaus A, Klingler PJ. Five- to eight-year outcome of the first laparoscopic Nissen fundoplications. J Gastrointest Surg. 2001 Jan-Feb;5(1):42-8. — 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

Campos GM, Peters JH, DeMeester TR, Oberg S, Crookes PF, Tan S, DeMeester SR, Hagen JA, Bremner CG. Multivariate analysis of factors predicting outcome after laparoscopic Nissen fundoplication. J Gastrointest Surg. 1999 May-Jun;3(3):292-300. — 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

Corley DA, Kubo A, Levin TR, Block G, Habel L, Zhao W, Leighton P, Quesenberry C, Rumore GJ, Buffler PA. Abdominal obesity and body mass index as risk factors for Barrett's esophagus. Gastroenterology. 2007 Jul;133(1):34-41; quiz 311. Epub 2007 Apr 25. — View Citation

Corley DA, Kubo A. Body mass index and gastroesophageal reflux disease: a systematic review and meta-analysis. Am J Gastroenterol. 2006 Nov;101(11):2619-28. Epub 2006 Sep 4. Review. — 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

D'Alessio MJ, Arnaoutakis D, Giarelli N, Villadolid DV, Rosemurgy AS. Obesity is not a contraindication to laparoscopic Nissen fundoplication. J Gastrointest Surg. 2005 Sep-Oct;9(7):949-54. — View Citation

Dallemagne B, Weerts J, Markiewicz S, Dewandre JM, Wahlen C, Monami B, Jehaes C. Clinical results of laparoscopic fundoplication at ten years after surgery. Surg Endosc. 2006 Jan;20(1):159-65. Epub 2005 Dec 7. — View Citation

Donnelly PE, Salgado JJ, Gagne DD, et al. Efficacy of laparoscopic Roux-en-Y gastric bypass (LRYGB) in obese patients with a previous fundoplication. Surg Obes Relat Dis 2007;3: 299-344.

Edelstein ZR, Farrow DC, Bronner MP, Rosen SN, Vaughan TL. Central adiposity and risk of Barrett's esophagus. Gastroenterology. 2007 Aug;133(2):403-11. Epub 2007 May 21. — View Citation

Fass R. The pathophysiological mechanisms of GERD in the obese patient. Dig Dis Sci. 2008 Sep;53(9):2300-6. doi: 10.1007/s10620-008-0411-y. Epub 2008 Jul 29. — 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

Frezza EE, Ikramuddin S, Gourash W, Rakitt T, Kingston A, Luketich J, Schauer P. Symptomatic improvement in gastroesophageal reflux disease (GERD) following laparoscopic Roux-en-Y gastric bypass. Surg Endosc. 2002 Jul;16(7):1027-31. Epub 2002 May 3. — View Citation

Hampel H, Abraham NS, El-Serag HB. Meta-analysis: obesity and the risk for gastroesophageal reflux disease and its complications. Ann Intern Med. 2005 Aug 2;143(3):199-211. — 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

Houghton SG, Nelson LG, Swain JM, Nesset EM, Kendrick ML, Thompson GB, Murr MM, Nichols FC, Sarr MG. Is Roux-en-Y gastric bypass safe after previous antireflux surgery? Technical feasibility and postoperative symptom assessment. Surg Obes Relat Dis. 2005 Sep-Oct;1(5):475-80. Epub 2005 Aug 31. — View Citation

Houghton SG, Romero Y, Sarr MG. Effect of Roux-en-Y gastric bypass in obese patients with Barrett's esophagus: attempts to eliminate duodenogastric reflux. Surg Obes Relat Dis. 2008 Jan-Feb;4(1):1-4; discussion 4-5. Epub 2007 Dec 19. — View Citation

Ikramuddin S. Surgical management of gastroesophageal reflux disease in obesity. Dig Dis Sci. 2008 Sep;53(9):2318-29. doi: 10.1007/s10620-008-0415-7. Epub 2008 Jul 29. — View Citation

Jacobson BC. Body mass index and the efficacy of acid-mediating agents for GERD. Dig Dis Sci. 2008 Sep;53(9):2313-7. doi: 10.1007/s10620-008-0414-8. Epub 2008 Jul 16. Review. — View Citation

Kellogg TA, Andrade R, Maddaus M, Slusarek B, Buchwald H, Ikramuddin S. Anatomic findings and outcomes after antireflux procedures in morbidly obese patients undergoing laparoscopic conversion to Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2007 Jan-Feb;3(1):52-7; discussion 58-9. Epub 2006 Nov 20. — View Citation

Kubo A, Corley DA. Body mass index and adenocarcinomas of the esophagus or gastric cardia: a systematic review and meta-analysis. Cancer Epidemiol Biomarkers Prev. 2006 May;15(5):872-8. Review. — View Citation

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

Morgenthal CB, Lin E, Shane MD, Hunter JG, Smith CD. Who will fail laparoscopic Nissen fundoplication? Preoperative prediction of long-term outcomes. Surg Endosc. 2007 Nov;21(11):1978-84. Epub 2007 Jul 11. — View Citation

Morgenthal CB, Shane MD, Stival A, Gletsu N, Milam G, Swafford V, Hunter JG, Smith CD. The durability of laparoscopic Nissen fundoplication: 11-year outcomes. J Gastrointest Surg. 2007 Jun;11(6):693-700. — 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'Boyle CJ, Watson DI, DeBeaux AC, Jamieson GG. Preoperative prediction of long-term outcome following laparoscopic fundoplication. ANZ J Surg. 2002 Jul;72(7):471-5. — View Citation

Patterson EJ, Davis DG, Khajanchee Y, Swanström LL. Comparison of objective outcomes following laparoscopic Nissen fundoplication versus laparoscopic gastric bypass in the morbidly obese with heartburn. Surg Endosc. 2003 Oct;17(10):1561-5. Epub 2003 Jul 21. — View Citation

Perez AR, Moncure AC, Rattner DW. Obesity adversely affects the outcome of antireflux operations. Surg Endosc. 2001 Sep;15(9):986-9. Epub 2001 Jun 12. — View Citation

Power C, Maguire D, McAnena O. Factors contributing to failure of laparoscopic Nissen fundoplication and the predictive value of preoperative assessment. Am J Surg. 2004 Apr;187(4):457-63. — View Citation

Raftopoulos I, Awais O, Courcoulas AP, Luketich JD. Laparoscopic gastric bypass after antireflux surgery for the treatment of gastroesophageal reflux in morbidly obese patients: initial experience. Obes Surg. 2004 Nov-Dec;14(10):1373-80. — View Citation

Santry HP, Gillen DL, Lauderdale DS. Trends in bariatric surgical procedures. JAMA. 2005 Oct 19;294(15):1909-17. — 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

Smith SC, Edwards CB, Goodman GN. Symptomatic and clinical improvement in morbidly obese patients with gastroesophageal reflux disease following Roux-en-Y gastric bypass. Obes Surg. 1997 Dec;7(6):479-84. — View Citation

Zainabadi K, Courcoulas AP, Awais O, Raftopoulos I. Laparoscopic revision of Nissen fundoplication to Roux-en-Y gastric bypass in morbidly obese patients. Surg Endosc. 2008 Dec;22(12):2737-40. doi: 10.1007/s00464-008-9848-5. Epub 2008 Mar 25. — View Citation

* Note: There are 38 references in all — Click here to view all references

Outcome

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 4 years	Yes
Primary	Remission or improvement of GERD-related symptoms		6 months, 1 year and annually thereafter for up to 4 years	No
Primary	Weight loss expressed as Body Mass Index and Percentage of excess weight loss		6 months, 1 year, and annually thereafter for up to 4 years	No
Secondary	Remission or improvement of comorbidities		6 months, 1 year, and annually thereafter for up to 4 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	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

External Links

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