A Prospective Blinded Randomized Study Comparing Laparoscopic Sleeve Gastrectomy and Laparoscopic Roux-en-y Gastric Bypass and Their Effect on Gastro-Esophageal Reflux Disease Using 24 Horus pH Monitoring (GERD)

Obesity has become a significant health problem in Canada. It is known to be a risk factor for many diseases, including Gastro-Esophageal Reflux Disease (GERD). When medical efforts to lose weight fail, patients often consider bariatric surgical procedures as the next step. The two most common bariatric procedures performed are Roux-en-Y Gastric Bypass (LRYGB) and Laparoscopic Sleeve Gastrectomy (LSG). The gold standard for diagnosing GERD is Esophageal pH monitoring, as it is the most objective method to document the reflux, assess the severity and monitor the response to treatment of the disease. In the last few years LSG has gained in popularity due to its simplicity and short operative time. Currently the comparison between bariatric surgery and GERD symptoms is very one sided. There are significant numbers of studies with conclusive results that state that LRYGB has a positive effect on GERD symptoms, however there is little evidence that states the same about LSG. This means that the relationship between LSG and GERD is inconclusive. An objective evaluation of GERD using 24 hour pH monitoring and validated CRFs at different follow up time points will contribute greatly to our understanding of what this relationship might be.

Study Overview

• Status: Suspended
• Conditions: GERD
• Intervention / Treatment: Other: 24 pH monitoring; Other: Esophageal Manometry:

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Fulfilled criteria for bariatric surgery as coined by National Institutes of Health conference.
• Their age is ≥18 years and ≤70 years
• The group with symptoms of GERD needs to have diagnosis of GERD in their medical record and taking proton pump inhibitors on a daily basis.
• Able and willing to give written consent
• The patient is willing to perform the pre-operative tests required for this study.
• The patient fits for both surgeries - LSG or LRYGB

Exclusion Criteria:

• Previous bariatric surgery
• Previous anti reflux procedure
• Contra-indication to general anesthesia
• Any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
• Pregnant or lactating female (Women of child bearing potential must take a pregnancy test prior to surgery)
• Hiatal hernia above 4cm (measured in the pre-operative gastroscopy).
• Multiple surgeries in abdominal cavity or previous small bowel disease/resection
• Patient on CPAP treatment for his OSA disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: GERD Symptoms	Other: 24 pH monitoring; The study is performed with the patient fasting for a minimum of 6 hours. A single channel or dual channel (15 cm spacing) pH probe is inserted trans nasally. The pH sensor, or distal pH sensor in the case of 2 channel testing, is positioned 5 cm above the proximal margin of the LES, as determined by esophageal manometric testing. pH-Z ambulatory monitor (Given Imaging Digitrapper) is used for data acquisition and the data analyzed with pH Analysis Program (Given Imaging AccuView). The number of reflux events, defined as a drop in esophageal pH readings below 4.0, is recorded and the percentage of time with esophageal acid exposure is analyzed using defined protocols and accepted normal values.; Other: Esophageal Manometry: A high resolution esophageal manometry catheter is used for testing and inserted Trans nasally. The patient is given 10 liquid swallows (5mL of water), at intervals of approximately 30 seconds. The catheter (Sierra Scientific/Given Imaging) has 36 sensors, each one averaging pressures from 12 circumferential positions. This gives a total of 432 data points. The sensors are placed 1 cm apart, spanning a length of 35 cm. The catheter simultaneously records pressure readings from the esophagus, sphincter regions (UES and LES), pharynx and stomach without the need for a station pull-through technique. Results are reported according to defined protocols and accepted normal values.
ACTIVE_COMPARATOR: No GERD Symptoms	Other: 24 pH monitoring; The study is performed with the patient fasting for a minimum of 6 hours. A single channel or dual channel (15 cm spacing) pH probe is inserted trans nasally. The pH sensor, or distal pH sensor in the case of 2 channel testing, is positioned 5 cm above the proximal margin of the LES, as determined by esophageal manometric testing. pH-Z ambulatory monitor (Given Imaging Digitrapper) is used for data acquisition and the data analyzed with pH Analysis Program (Given Imaging AccuView). The number of reflux events, defined as a drop in esophageal pH readings below 4.0, is recorded and the percentage of time with esophageal acid exposure is analyzed using defined protocols and accepted normal values.; Other: Esophageal Manometry: A high resolution esophageal manometry catheter is used for testing and inserted Trans nasally. The patient is given 10 liquid swallows (5mL of water), at intervals of approximately 30 seconds. The catheter (Sierra Scientific/Given Imaging) has 36 sensors, each one averaging pressures from 12 circumferential positions. This gives a total of 432 data points. The sensors are placed 1 cm apart, spanning a length of 35 cm. The catheter simultaneously records pressure readings from the esophagus, sphincter regions (UES and LES), pharynx and stomach without the need for a station pull-through technique. Results are reported according to defined protocols and accepted normal values.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observe acid exposure to the distal esophagus	This will be measured using the esophageal 24 hours monitoring before surgery and at the 6 month follow up. The patients will be randomized to two different types of surgery and the results compared.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare GERD symptoms in patients.	This will be measured using esophageal manometry prior to surgery and at the six month follow up visit. We are looking for time in minutes with a pH of below 4 and a Demeeser score of below 14.7	1 year

Collaborators and Investigators

• Sponsor: McMaster University

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: March 24, 2014
• First Submitted That Met QC Criteria: May 16, 2014
• First Posted (ESTIMATE): May 20, 2014

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: GERD; Laparoscopic; gastrectomy; sleeve
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: 14-001