NCT02618044

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2006

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

8.8 years

First QC Date

November 24, 2015

Last Update Submit

December 2, 2015

Conditions

Gastroesophageal RefluxObesity

Keywords

Gastroesophageal refluxObesityEsophageal manometry24 H impedance pH-monitoringLaparoscopic Roux-en-Y Gastric Bypass

Outcome Measures

Primary Outcomes (1)

  • Number of weakly acidic reflux

    number of weakly acidic reflux at 24 hour pH impedance monitoring

    preoperatively, 12 and 60 months after LRYGB

Secondary Outcomes (5)

  • GERD-HRQoL clinical score

    preoperatively, 12 and 60 months after LRYGB

  • Lower esophageal sphincter pressure

    preoperatively, 12 and 60 months after LRYGB

  • Amplitude of esophageal peristaltic waves

    preoperatively, 12 and 60 months after LRYGB

  • Grade of esophagitis

    preoperatively, 12 and 60 months after LRYGB

  • Number of acidic reflux

    preoperatively, 12 and 60 months after LRYGB

Study Arms (2)

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+)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Consecutive morbidly obese patients selected for LRYGB

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 19190606RESULT

  • 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.

    PMID: 12184547RESULT

  • 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.

    PMID: 10875990RESULT

  • 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.

    PMID: 15122609RESULT

  • 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.

    PMID: 12119661RESULT

  • 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.

    PMID: 27429035DERIVED

MeSH Terms

Conditions

Gastroesophageal RefluxObesity

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 24, 2015

First Posted

December 1, 2015

Study Start

May 1, 2006

Primary Completion

February 1, 2015

Study Completion

July 1, 2015

Last Updated

December 3, 2015

Record last verified: 2015-12