Gastroesophageal Reflux Disease Clinical Trial
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.
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.
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Observational Model: Cohort, Time Perspective: Retrospective
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