Clinical trial NCT05365087: Transoral Fundoplication Prior to Sleeve Gastrectomy Versus RNY Gastric Bypass on GERD Symptoms in Bariatric Patients
Official title: The Effect of Endoscopic Fundoplication Prior to Sleeve Gastrectomy Versus Gastric Bypass on Reflux Symptoms in Bariatric Patients With Gastroesophageal Reflux Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
Lead sponsor: Lexington Health Incorporated
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen for bariatric surgery consultation who report a history or current symptoms of GERD, or who are taking some form of medication for treatment of GERD, are asked to complete the Gastroesophageal Reflux Disease-Health Related Quality of Life Questionnaire GERD-HRQL. The GERD-HRQL is a validated, reliable and practical standard instrument which assesses the impact and severity of reflux symptoms on a patient's quality of life. The use of the GERD-HQRL for this purpose reflects a standard of care in the evaluation of any patient presenting with GERD symptoms.

Brief summary: 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.

Detailed description: 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

1. Patient Identification

1. Patients seen for bariatric surgery consultation who report a history or current symptoms of GERD, or who are taking some form of medication for treatment of GERD, are asked to complete the Gastroesophageal Reflux Disease-Health Related Quality of Life Questionnaire .The GERD-HRQL is a validated, reliable and practical standard instrument which assesses the impact and severity of reflux symptoms on a patient's quality of life. The use of the GERD-HQRL for this purpose reflects a standard of care in the evaluation of any patient presenting with GERD symptoms.
2. The GERD-HRQL consists of 11 questions which focus on disease symptoms such as heartburn, difficulty swallowing, bloating, and pain, as well as the effect of these symptoms on daily life and an individual's satisfaction with their current condition. Symptoms are scored from 0 to 5, 0= no symptoms, 1= symptoms noticeable but not bothersome, 2= symptoms noticeable and bothersome but not every day, 3= symptoms bothersome every day, 4= symptoms affect daily activities, 5= symptoms are incapacitating, and unable to do activities. The summation of this score represents the severity and frequency of typical GERD symptoms. A score of 13 or higher on the GERD-HRQL warrants further diagnostic workup which may include the following: esophagogastroduodenoscopy, esophageal ambulatory pH study, esophageal manometry, and an upper gastrointestinal series.
3. Each patient is then presented at the GERD conference where treatment options are discussed and determined. The GERD conference is a multi-disciplinary meeting in which the patient's diagnostic results are presented in consideration of their personal history and comorbidities; based on these results, medical history and present status, treatment plans are discussed in order to provide the patient with the best possible outcome.
4. Treatment options are then presented to the patient, who ultimately decides the course of action. In general, patients are allowed to choose the surgical option that meets their treatment goals if they are able to demonstrate a clear understanding of the risks, benefits and indications for each choice. Therefore, patients are not randomized to one procedure.
5. GERD conferences will be retrospectively reviewed from March 2018 to February 2020 to identify bariatric patients with GERD who chose to undergo the TF procedure followed by the LGS or LRNGB. Thereafter, a continuing review following each GERD conference identifies patients suitable for study inclusion.
6. Patients who chose to undergo the TF to Sleeve route or who chose to undergo the LRYGB will be asked to consider consenting for their information to be part of this study. All patients who meet the proposal criteria will be approached by the study researchers until there are 60 patients enrolled in each category. Upon agreement, the patient's consent of the study will be appropriately documented.
7. Patients who choose LSG or TF to LSG will undergo screening endoscopies at the following postoperative LSG intervals: 12 months, three years, five years and 10 years.
8. A cohort of 60 patients who presented preoperatively with no evidence of GERD and underwent LSG, and who complete standard surveillance endoscopy postoperatively will be included in the study to provide a baseline from which to compare effectiveness of treatment.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Incomplete records missing any component of the demographic data to be analyzed
* Patients who undergo Roux-en-Y Gastric Bypass conversion from Sleeve Gastrectomy

Primary outcomes:
measure: 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
timeFrame: 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
Secondary outcomes:
measure: Measure change in Body Mass Index, BMI
timeFrame: 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.
Other outcomes:
Locations:
city: West Columbia
country: United States
facility: Lexington Health Incorporated
state: South Carolina
Study officials:
affiliation: Lexington Health Incorporated
name: Marc Antonetti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barr AC, Frelich MJ, Bosler ME, Goldblatt MI, Gould JC. GERD and acid reduction medication use following gastric bypass and sleeve gastrectomy. Surg Endosc. 2017 Jan;31(1):410-415. doi: 10.1007/s00464-016-4989-4. Epub 2016 Jun 10.
citation: DuPree CE, Blair K, Steele SR, Martin MJ. Laparoscopic sleeve gastrectomy in patients with preexisting gastroesophageal reflux disease : a national analysis. JAMA Surg. 2014 Apr;149(4):328-34. doi: 10.1001/jamasurg.2013.4323.
citation: Rondelli F, Bugiantella W, Vedovati MC, Mariani E, Balzarotti Canger RC, Federici S, Guerra A, Boni M. Laparoscopic gastric bypass versus laparoscopic sleeve gastrectomy: A retrospective multicenter comparison between early and long-term post-operative outcomes. Int J Surg. 2017 Jan;37:36-41. doi: 10.1016/j.ijsu.2016.11.106. Epub 2016 Nov 29.
citation: Tai CM, Huang CK. Increase in gastroesophageal reflux disease symptoms and erosive esophagitis 1 year after laparoscopic sleeve gastrectomy among obese adults. Surg Endosc. 2013 Oct;27(10):3937. doi: 10.1007/s00464-013-3022-4. Epub 2013 May 25. No abstract available.
citation: Testoni PA, Testoni S, Mazzoleni G, Vailati C, Passaretti S. Long-term efficacy of transoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-center study. Surg Endosc. 2015 Sep;29(9):2770-80. doi: 10.1007/s00464-014-4008-6. Epub 2014 Dec 6.
citation: Trad KS, Turgeon DG, Deljkich E. Long-term outcomes after transoral incisionless fundoplication in patients with GERD and LPR symptoms. Surg Endosc. 2012 Mar;26(3):650-60. doi: 10.1007/s00464-011-1932-6. Epub 2011 Sep 30.