Laparoscopic Sleeve Gastrectomy and Gastroesophageal Acid Reflux

• Sponsor: University of Turin, Italy (Other)
• Overall Status: Completed
• CT.gov ID: NCT02012894
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Duration (Months): 51
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux; Obesity

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 65 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Physiopathologic Evaluation of Esophageal Function After Laparoscopic Sleeve Gastrectomy
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

1. Change from baseline in DeMeester's score [baseline, 24 months after LSG]

   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

Secondary Outcome Measures

1. Change from baseline in lower esophageal sphincter pressure [baseline, 24 months after LSG]

   Esophageal manometry measures several parameters including lower esophageal sphincter pressure

2. Change from baseline in amplitude of esophageal peristaltic waves [baseline, 24 months after LSG]

   Esophageal manometry evaluates quality and amplitude of esophageal peristalsis

3. Change from baseline in grade of esophagitis [baseline, 24 months after LSG]

   Upper endoscopy is performed to assess preoperative and postoperative presence and severity of esophagitis

4. Change from baseline in Gastroesophageal reflux disease Symptom Assessment Scale score [Baseline, 24 months after LSG]

   Standard and validated questionnaire is used to assess gastroesophageal symptoms and quality of life

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Turin	Turin		Italy	10126

Sponsors and Collaborators

• University of Turin, Italy

Investigators

• Principal Investigator: Fabrizio Rebecchi, MD, University of Turin, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Fabrizio Rebecchi, MD, University of Turin, Italy
• ClinicalTrials.gov Identifier: NCT02012894
• Other Study ID Numbers: RGEOB/76
• First Posted: Dec 16, 2013
• Last Update Posted: Dec 16, 2013
• Last Verified: Dec 1, 2013

• Keywords provided by Fabrizio Rebecchi, MD, University of Turin, Italy: Obesity; Gastroesophageal reflux; sleeve gastrectomy; pH-monitoring; manometry
• Additional relevant MeSH terms: Gastroesophageal Reflux

Study Results

No Results Posted as of Dec 16, 2013