Clinically Severe ObesityRYGBafterARSNCT01041105
Gastric Bypass After Previous Anti-reflux Surgery
An observational study of Clinically Severe Obesity and Gastroesophageal Reflux Disease, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Clinically Severe Obesity, Gastroesophageal Reflux Disease
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients who underwent laparoscopic Roux-en-Y gastric bypass (RYGB) after a previous functional or failed anti-reflux procedure and met National Institutes of Health criteria for bariatric surgery.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Fresno Center for Medical Education and Research
Fresno, California, 93701
About this study
Official title: Laparoscopic Revision Roux-en-Y Gastric Bypass Surgery After Previous Anti-rflux Surgery: Intermediate Results
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.
Read the detailed 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.
- Keywords
- Obesity, Gastroesophageal Reflux Disease, Nissen funduplication, Antireflux surgery, Revisional Gastric Bypass, Re-operative bariatric surgery, Bariatric surgery, Nissen, Conversion of Nissen to Gastric Bypass
- Medical subject headings
- Gastroesophageal Reflux, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gastric bypass after previous Nissen | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity and mortality
Measured: at discharge, 1 week, 3 weeks, 8 weeks, 3 months, 6 months, 1 year and annually thereafter for up to 4 years
Remission or improvement of GERD-related symptoms
Measured: 6 months, 1 year and annually thereafter for up to 4 years
Weight loss expressed as Body Mass Index and Percentage of excess weight loss
Measured: 6 months, 1 year, and annually thereafter for up to 4 years
Secondary outcomes (3)
Remission or improvement of comorbidities
Measured: 6 months, 1 year, and annually thereafter for up to 4 years
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
Measured: 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
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.
Measured: It is measured in days from the admission date to the discharge date for the hospitalization pertaining to revisional surgery under study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2009 (estimated)
- Study startDec 2008
- Primary completionJun 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Clinically Severe ObesityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Investigators
- Francisco M Tercero, MD, Study director, Research Associate, University of California San FranciscoKelvin D Higa, MD, Principal investigator, Professor of Surgery, University of California San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041105
- Sponsor's protocol ID
- CMC IRB No. 2008086
- Other IDs
- U1111-1112-9919
- Acronym
- RYGBafterARS
- Status last verified
- Dec 2009
- First submitted
- 26 Dec 2009
- Last updated
- 1 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 10982506Hedley 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.
PubMed 15199035McTigue 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.
PubMed 14644897Buchwald 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.
PubMed 15479938Christou 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.
PubMed 15319713Adams 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.
PubMed 17715409Sjostrom 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.
PubMed 17715408Cremieux 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.
PubMed 18778174Santry 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.
PubMed 16234497Flum 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.
PubMed 17895461Meguid 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.
PubMed 18725080Nguyen 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.
PubMed 17828427Hampel 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. doi: 10.7326/0003-4819-143-3-200508020-00006.
PubMed 16061918Corley 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. doi: 10.1111/j.1572-0241.2006.00849.x. Epub 2006 Sep 4.
PubMed 16952280Kubo 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. doi: 10.1158/1055-9965.EPI-05-0860.
PubMed 16702363
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Revision Roux-en-Y Gastric Bypass Surgery After Previous Anti-rflux Surgery: Intermediate Results
- ClinicalTrials.gov ID
- NCT01041105
- Acronym / sponsor ID
- RYGBafterARS / CMC IRB No. 2008086
- Keywords
- Obesity, Gastroesophageal Reflux Disease, Nissen funduplication, Antireflux surgery, Revisional Gastric Bypass, Re-operative bariatric surgery, Bariatric surgery, Nissen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 31 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric bypass after previous Nissen | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who underwent laparoscopic Roux-en-Y gastric bypass (RYGB) after a previous functional or failed anti-reflux procedure and met National Institutes of Health criteria for bariatric surgery.
Key inclusion criteria (4 listed)
- Status post, either open or laparoscopic, primary Nissen fundoplication with all the following requirements:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Morbidity and mortality
Time frame: at discharge, 1 week, 3 weeks, 8 weeks, 3 months, 6 months, 1 year and annually thereafter for up to 4 years
Remission or improvement of GERD-related symptoms
Time frame: 6 months, 1 year and annually thereafter for up to 4 years
Weight loss expressed as Body Mass Index and Percentage of excess weight loss
Time frame: 6 months, 1 year, and annually thereafter for up to 4 years
3 secondary outcomes
Remission or improvement of comorbidities
Time frame: 6 months, 1 year, and annually thereafter for up to 4 years
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
Time frame: 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
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.
Time frame: It is measured in days from the admission date to the discharge date for the hospitalization pertaining to revisional surgery under study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2010.
- Background: PubMed 10982506Higa 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.
- Background: PubMed 15199035Hedley 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.
- Background: PubMed 14644897McTigue 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.
- Background: PubMed 15479938Buchwald 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.
- Background: PubMed 15319713Christou 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.
- Background: PubMed 17715409Adams 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.
- Background: PubMed 17715408Sjostrom 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.
- Background: PubMed 18778174Cremieux 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.
- Background: PubMed 16234497Santry 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.
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- "Click here for more information about the department sponsor´s web site"Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco M Tercero, MD study director
Research Associate, University of California San Francisco
Kelvin D Higa, MD principal investigator
Professor of Surgery, University of California San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinically Severe Obesity and Gastroesophageal Reflux Disease, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity and mortality (time frame: at discharge, 1 week, 3 weeks, 8 weeks, 3 months, 6 months, 1 year and annually thereafter for up to 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01041105, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2010.