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Completed

NCT Number: NCT02012894

Laparoscopic Sleeve Gastrectomy and Gastroesophageal Acid Reflux

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Turin

Turin, 10126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change from baseline in DeMeester's score

    Time frame: 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 outcomes

  1. Change from baseline in lower esophageal sphincter pressure

    Time frame: 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

    Time frame: baseline, 24 months after LSG

    Esophageal manometry evaluates quality and amplitude of esophageal peristalsis

  3. Change from baseline in grade of esophagitis

    Time frame: 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

    Time frame: Baseline, 24 months after LSG

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

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

Physiopathologic Evaluation of Esophageal Function After Laparoscopic Sleeve Gastrectomy

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Dec 16, 2013
Registry last updated
Dec 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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