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Completed

NCT Number: NCT02618044

Laparoscopic Roux-en-Y Gastric Bypass and Gastro-esophageal Reflux

Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is considered the weight loss procedure of choice for patients suffering of gastro-esophageal reflux (GER). However, long term instrumental evaluations of GER after LRYGB are not available.

The aim of this study is to evaluate the long-term effects of laparoscopic Roux-en-Y Gastric Bypass (LRYGB) on gastro-esophageal function.

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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

About this study

Consecutive morbidly obese patients selected for LRYGB were included in a prospective study. The investigators performed clinical evaluation with GERD-HRQoL and GIS questionnaire, upper endoscopy, esophageal manometry and 24h-impedance pH monitoring (24h-MII-pH) preoperatively and at 12 and 60 months after surgery. Patients were divided into 2 groups according to the presence of GER at preoperative 24h-MII-pH.

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. Number of weakly acidic reflux

    Time frame: preoperatively, 12 and 60 months after LRYGB

    number of weakly acidic reflux at 24 hour pH impedance monitoring

Secondary outcomes

  1. GERD-HRQoL clinical score

    Time frame: preoperatively, 12 and 60 months after LRYGB

    Standard and previous validated questionnaire was employed in the study to assess gastroesophageal function and quality of life

  2. Lower esophageal sphincter pressure

    Time frame: preoperatively, 12 and 60 months after LRYGB

    Esophageal manometry measures lower esophageal sphincter pressure

  3. Amplitude of esophageal peristaltic waves

    Time frame: preoperatively, 12 and 60 months after LRYGB

    Esophageal manometry evaluates amplitude of esophageal peristalsis

  4. Grade of esophagitis

    Time frame: preoperatively, 12 and 60 months after LRYGB

    Upper endoscopy is performed to assess the presence of esophagitis

  5. Number of acidic reflux

    Time frame: preoperatively, 12 and 60 months after LRYGB

    number of acidic reflux at 24 hour pH impedance monitoring

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

Long Term Effects of Laparoscopic Roux-en-Y Gastric Bypass on Gastro-esophageal Reflux: Clinical Impact of Weakly Acidic Reflux

Important dates

Study start
2006
Primary completion
2015
Study completion
2015
First posted
Dec 1, 2015
Registry last updated
Dec 3, 2015

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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