Laparoscopic Sleeve Gastrectomy and Gastroesophageal Acid Reflux

Obesity Clinical Trial

Official title:

Physiopathologic Evaluation of Esophageal Function After Laparoscopic Sleeve Gastrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02012894
• Other study ID #: RGEOB/76
• Status: Completed
• Phase: N/A
• First received: December 5, 2013
• Last updated: December 10, 2013
• Start date: June 2009
• Est. completion date: September 2013

Study information

• Verified date: December 2013
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Description:

Consecutive morbidly obese patients selected for LSG are included in a prospective clinical study. Gastroesophageal function is evaluated using a clinical validated questionnaire, upper endoscopy, esophageal manometry and 24-h pH monitoring before and 24 months after LSG.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 2013
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Obesity

Locations

Country	Name	City	State
Italy	University of Turin	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. Review. — View Citation

Petersen WV, Meile T, Küper MA, Zdichavsky M, Königsrainer 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change from baseline in lower esophageal sphincter pressure	Esophageal manometry measures several parameters including lower esophageal sphincter pressure	baseline, 24 months after LSG	No
Secondary	Change from baseline in amplitude of esophageal peristaltic waves	Esophageal manometry evaluates quality and amplitude of esophageal peristalsis	baseline, 24 months after LSG	No
Secondary	Change from baseline in grade of esophagitis	Upper endoscopy is performed to assess preoperative and postoperative presence and severity of esophagitis	baseline, 24 months after LSG	No
Secondary	Change from baseline in Gastroesophageal reflux disease Symptom Assessment Scale score	Standard and validated questionnaire is used to assess gastroesophageal symptoms and quality of life	Baseline, 24 months after LSG	No