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CompletedNCT02618044Updated Dec 3, 2015

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

An observational study in Gastroesophageal Reflux and Obesity, sponsored by University of Turin, Italy. Completed. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-12-03.

Sponsored by University of Turin, Italy · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
86
Ages
18 Years to 60 Years
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Gastroesophageal Reflux
  • Obesity

Keywords

  • Gastroesophageal reflux
  • Obesity
  • Esophageal manometry
  • 24 H impedance pH-monitoring
  • Laparoscopic Roux-en-Y Gastric Bypass
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In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 86 is below the median of 180 across 298 observational studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

University of Turin, Italy is the lead sponsor of 206 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Consecutive morbidly obese patients selected for LRYGB

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
86 participants (actual)
Patient registry
No

Groups and cohorts

  • Obese patients without preoperative GER

    Obese patients selected for laparoscopic Roux-en-Y Gastric Bypass without preoperative GER at 24h-impedance pH monitoring (Group G-)

  • Obese patients with preoperative GER

    Obese patients selected for laparoscopic Roux-en-Y Gastric Bypass with preoperative GER at 24h-impedance pH monitoring (Group G+)

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What researchers measure

Primary outcomes

  1. Number of weakly acidic reflux

    number of weakly acidic reflux at 24 hour pH impedance monitoring

    Time frame: preoperatively, 12 and 60 months after LRYGB

Secondary outcomes

  1. GERD-HRQoL clinical score

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

    Time frame: preoperatively, 12 and 60 months after LRYGB

  2. Lower esophageal sphincter pressure

    Esophageal manometry measures lower esophageal sphincter pressure

    Time frame: preoperatively, 12 and 60 months after LRYGB

  3. Amplitude of esophageal peristaltic waves

    Esophageal manometry evaluates amplitude of esophageal peristalsis

    Time frame: preoperatively, 12 and 60 months after LRYGB

  4. Grade of esophagitis

    Upper endoscopy is performed to assess the presence of esophagitis

    Time frame: preoperatively, 12 and 60 months after LRYGB

  5. Number of acidic reflux

    number of acidic reflux at 24 hour pH impedance monitoring

    Time frame: preoperatively, 12 and 60 months after LRYGB

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Vela MF. Non-acid reflux: detection by multichannel intraluminal impedance and pH, clinical significance and management. Am J Gastroenterol. 2009 Feb;104(2):277-80. doi: 10.1038/ajg.2008.23. No abstract available. PubMed 19190606 ↗
  • Sundbom M, Hedenstrom H, Gustavsson S. Duodenogastric bile reflux after gastric bypass: a cholescintigraphic study. Dig Dis Sci. 2002 Aug;47(8):1891-6. doi: 10.1023/a:1016429603337. PubMed 12184547 ↗
  • Collard JM, Romagnoli R. Roux-en-Y jejunal loop and bile reflux. Am J Surg. 2000 Apr;179(4):298-303. doi: 10.1016/s0002-9610(00)00326-3. PubMed 10875990 ↗
  • Mabrut JY, Collard JM, Romagnoli R, Gutschow C, Salizzoni M. Oesophageal and gastric bile exposure after gastroduodenal surgery with Henley's interposition or a Roux-en-Y loop. Br J Surg. 2004 May;91(5):580-5. doi: 10.1002/bjs.4569. PubMed 15122609 ↗
  • Barak N, Ehrenpreis ED, Harrison JR, Sitrin MD. Gastro-oesophageal reflux disease in obesity: pathophysiological and therapeutic considerations. Obes Rev. 2002 Feb;3(1):9-15. doi: 10.1046/j.1467-789x.2002.00049.x. PubMed 12119661 ↗
  • Rebecchi F, Allaix ME, Ugliono E, Giaccone C, Toppino M, Morino M. Increased Esophageal Exposure to Weakly Acidic Reflux 5 Years After Laparoscopic Roux-en-Y Gastric Bypass. Ann Surg. 2016 Nov;264(5):871-877. doi: 10.1097/SLA.0000000000001775. PubMed 27429035 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02618044
Lead sponsor
University of Turin, Italy
Responsible party
Fabrizio Rebecchi (MD, University of Turin, Italy) — Principal investigator
First posted
Dec 1, 2015
Start date
May 2006
Primary completion
Feb 2015
Completion
Jul 2015
Last update
Dec 3, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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