Laparoscopic Sleeve Gastrectomy and Gastroesophageal Acid Reflux

NCT02012894 | Completed

• 1 other identifier: RGEOB/76
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Symptomatic Gastroesophageal Reflux (GER) is considered by many a contraindication to laparoscopic sleeve gastrectomy (LSG). However, of the few studies that have investigated the relationship between LSG and GER the majority reported only changes in symptoms and manometric data, while assessment of GER using 24-hour pH monitoring is lacking. The aim of this study is to evaluate the effect of LSG on GER in morbidly obese patients.

Conditions

Gastroesophageal Reflux; Obesity

Keywords

Obesity; Gastroesophageal reflux; sleeve gastrectomy; pH-monitoring; manometry

Outcome Measures

Primary Outcomes (1)

• Change from baseline in DeMeester's score

  Use of the composite score that evaluates GER at 24-h pH monitoring before and 24 months after LSG. It includes numbers of reflux episodes, upright time in reflux, recumbent time in reflux, total time in reflux, reflux episodes over 5 minutes, longest reflux episodes

  baseline, 24 months after LSG

Secondary Outcomes (4)

• Change from baseline in lower esophageal sphincter pressure

  baseline, 24 months after LSG

• Change from baseline in amplitude of esophageal peristaltic waves

  baseline, 24 months after LSG

• Change from baseline in grade of esophagitis

  baseline, 24 months after LSG

• Change from baseline in Gastroesophageal reflux disease Symptom Assessment Scale score

  Baseline, 24 months after LSG

Study Arms (2)

Obese patients with preoperative GER

Obese patients selected for laparoscopic sleeve gastrectomy with preoperative GER at 24 H pH-monitoring (Group A)

Obese patients without preoperative GER

Obese patients selected for laparoscopic sleeve gastrectomy without preoperative GER at 24 H pH-monitoring (Group B)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Consecutive morbidly obese patients selected for LSG

You may qualify if:

• history of obesity exceeding 5 years
• documented previous weight loss attempts,
• body mass index (BMI)) of 40-50 kg/m2
• age of 18-60 years.

You may not qualify if:

• contraindications to pneumoperitoneum
• large esophageal hiatal hernia
• pregnancy,
• drug or alcohol abuse,
• psychological disorders (e.g., bulimia, depression)
• hormonal or genetic obesity-related disease,
• previous gastric surgery

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

University of Turin

Turin, Turin, 10126, Italy

Location

Related Publications (4)

• Tai CM, Huang CK, Lee YC, Chang CY, Lee CT, Lin JT. Increase in gastroesophageal reflux disease symptoms and erosive esophagitis 1 year after laparoscopic sleeve gastrectomy among obese adults. Surg Endosc. 2013 Apr;27(4):1260-6. doi: 10.1007/s00464-012-2593-9. Epub 2012 Dec 12.

  PMID: 23232995 BACKGROUND

• Petersen WV, Meile T, Kuper MA, Zdichavsky M, Konigsrainer A, Schneider JH. Functional importance of laparoscopic sleeve gastrectomy for the lower esophageal sphincter in patients with morbid obesity. Obes Surg. 2012 Mar;22(3):360-6. doi: 10.1007/s11695-011-0536-5.

  PMID: 22065341 BACKGROUND

• Mahawar KK, Jennings N, Balupuri S, Small PK. Sleeve gastrectomy and gastro-oesophageal reflux disease: a complex relationship. Obes Surg. 2013 Jul;23(7):987-91. doi: 10.1007/s11695-013-0899-x.

  PMID: 23460263 BACKGROUND

• Rebecchi F, Allaix ME, Giaccone C, Ugliono E, Scozzari G, Morino M. Gastroesophageal reflux disease and laparoscopic sleeve gastrectomy: a physiopathologic evaluation. Ann Surg. 2014 Nov;260(5):909-14; discussion 914-5. doi: 10.1097/SLA.0000000000000967.

  PMID: 25379861 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Obesity

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fabrizio Rebecchi, MD

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 16, 2013
• Study Start: June 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2013
• Last Updated: December 16, 2013

Record last verified: 2013-12

Locations

IT (1)