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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02012894
Other study ID # RGEOB/76
Secondary ID
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


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
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