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Laparoscopic Sleeve Gastrectomy and Gastroesophageal Acid Reflux

NCT ID: NCT02012894

Last Updated: 2013-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastroesophageal Reflux Obesity

Keywords

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Obesity Gastroesophageal reflux sleeve gastrectomy pH-monitoring manometry

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Obese patients with preoperative GER

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

No interventions assigned to this group

Obese patients without preoperative GER

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

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Fabrizio Rebecchi

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fabrizio Rebecchi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Turin, Italy

Locations

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University of Turin

Turin, Turin, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 23232995 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22065341 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23460263 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25379861 (View on PubMed)

Other Identifiers

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RGEOB/76

Identifier Type: -

Identifier Source: org_study_id