The Effect of Endoscopic Fundoplication Prior to Sleeve Gastrectomy Versus Gastric Bypass on Reflux Symptoms in Bariatric Patients With Gastroesophageal Reflux Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Measure change in reflux symptoms, impact of symptoms, and satisfaction of current status with the Gastroesophageal Reflux Disease Health Related Quality of Life GERD HRQL-RSI Questionnaire
研究概览
简要总结
A retrospective and prospective cohort study to compare the effect of completing a Transoral Fundoplication procedure prior to Laparoscopic Sleeve Gastrectomy surgery to Laparoscopic Roux-en-Y Gastric Bypass in bariatric patients with Gastroesophageal Reflux Disease signs and symptoms. The aim of this study is to examine the effect of TF prior to sleeve gastrectomy as compared to Roux-en-Y Gastric Bypass on reflux symptoms in bariatric patients. Additional Follow up data until 10 years will be collected to evaluate for sequelae of GERD.
详细描述
Gastroesophageal Reflux Disease or GERD is a common condition that produces discomfort and can result in serious sequelae from frequent esophageal acid exposure, including Barrett's esophagus, erosive esophagitis, esophageal adenocarcinoma, voice changes, and asthma exacerbation. The prevalence of GERD in adults continues to increase in conjunction with the increase in obesity. Because obesity and GERD are clearly linked, an individual with obesity is four times more likely to develop esophageal carcinoma than in an individual with a normal BMI. Additionally, the incidence of GERD is proportional to rising BMI ranging from 23 to 50%. Weight loss is associated with decreased GERD symptoms. Bariatric surgery has proven to be effective in reducing BMI, which subsequently often reduces GERD. The laparoscopic sleeve gastrectomy is an effective weight loss tool; however, recent literature suggests a correlation of de novo or worsening reflux symptoms in bariatric patients within one year postoperatively, independent of weight loss. A study conducted by Tai,et al,.2013 found that the prevalence of GERD symptoms increased significantly from 12.1% to 47% after LSG. Additionally, of the 58 patients in the study who were asymptomatic prior to surgery, 44.8% developed GERD symptoms after LSG. Other studies have found that among patients with no preoperative GERD, 86% developed symptoms postoperatively.
The Laparoscopic Roux-en-Y gastric bypass has been touted as the gold standard to treat both obesity and GERD; however, this procedure has a higher morbidity rate. While LSG has relatively low rates of re-operations, the LRYGB carries significant lifetime risk for multiple operative procedures due to adhesive bowel obstruction, internal hernia, non-healing ulcers and intussusception. Furthermore, nutrient malabsorption following LRYGB can result in irreversible neurological complications, and accelerated, ongoing decline in bone mineral density.. Options for surgical correction of GERD are limited following bariatric surgery. However, options for anti-reflux procedures prior to undergoing bariatric surgery are viable, and may include Transoral Fundoplication.
Transoral fundoplication is an anti-reflux procedure which has proven to achieve long-lasting relief of gastroesophageal reflux symptoms, and eliminate, or reduce the use of proton pump inhibitors. Daily dependence on PPI's were eliminated in 75-80% of cases for up to six years in a 2014 study conducted by Testoni et al.. Although a TF procedure is not an option post bariatric surgery due to technical issues, it is available prior to LSG. With these surgeries working in tandem, patients may attain the benefits of both, as they are reciprocal in nature: TF provides anti-reflux barriers and LSG enables patients to lose weight, which ultimately decreases GER symptoms.
We propose that performing a TF procedure prior to a sleeve gastrectomy will result in a decrease in GERD symptoms similar to that of a LRYGB. In addition to evaluating symptoms, we will perform endoscopy screening post bariatric surgery at one, three, five and 10 years or more often as indicated , to assess for asymptomatic GERD and its sequelae..
Population to be Reviewed
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bariatric patients who have documented GERD per GERD-HRQL at initial consultation and confirmed by preoperative testing
- •60 bariatric patients who received or plan to have the TF procedure prior to Sleeve Gastrectomy
- •60 bariatric patients who underwent or plan to undergo Roux-en-Y Gastric Bypass
- •Male or female
- •Ages 18 or older
- •Bariatric patients who have no evidence of GERD per GERD-HRQL at initial consultation or on preoperative testing.
- •60 bariatric patients who received or plan to undergo LSG and who complete surveillance endoscopy one year postoperatively
排除标准
- •Incomplete records missing any component of the demographic data to be analyzed
- •Patients who undergo Roux-en-Y Gastric Bypass conversion from Sleeve Gastrectomy
结局指标
主要结局
Measure change in reflux symptoms, impact of symptoms, and satisfaction of current status with the Gastroesophageal Reflux Disease Health Related Quality of Life GERD HRQL-RSI Questionnaire
时间窗: TS Cohort : Initial consultation, up to 6 weeks post fundoplication, up to 6 months post sleeve gastrectomy. RNY Cohort : At initial consultation, up to 6 months post RNY
The GERD HRQL-RSI Questionnaire quantifies the symptoms of reflux the patient experiences, as well as the impact of symptoms on their daily life, and their satisfaction with their current status. The questionnaire also evaluates reflux medication use, which is another measure of treatment effectiveness. Items are rated on a scale of 0-5. The lowest possible score equals no symptoms.
次要结局
- Measure change in Body Mass Index, BMI(TS Cohort: Initial Consultation, up to 6 weeks post fundoplication, up to 6 months post sleeve gastrectomy, 12 months post LSG. For the RNY Cohort, Initial Consultation and up to 6 months post RNY and 12 month post RNY.)
研究者
Marc Antonetti, MD
Principal Investigator
Lexington Health Incorporated
