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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02618044
• Other study ID #: WAROB/97
• Status: Completed
• Phase: N/A
• First received: November 24, 2015
• Last updated: December 2, 2015
• Start date: May 2006
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: July 2015
• Est. primary completion date: February 2015
• 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

• Gastroesophageal Reflux
• Obesity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

References & Publications (5)

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. Review. — View Citation

Collard JM, Romagnoli R. Roux-en-Y jejunal loop and bile reflux. Am J Surg. 2000 Apr;179(4):298-303. — View Citation

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. — View Citation

Sundbom M, Hedenström H, Gustavsson S. Duodenogastric bile reflux after gastric bypass: a cholescintigraphic study. Dig Dis Sci. 2002 Aug;47(8):1891-6. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of weakly acidic reflux	number of weakly acidic reflux at 24 hour pH impedance monitoring	preoperatively, 12 and 60 months after LRYGB	Yes
Secondary	GERD-HRQoL clinical score	Standard and previous validated questionnaire was employed in the study to assess gastroesophageal function and quality of life	preoperatively, 12 and 60 months after LRYGB	Yes
Secondary	Lower esophageal sphincter pressure	Esophageal manometry measures lower esophageal sphincter pressure	preoperatively, 12 and 60 months after LRYGB	Yes
Secondary	Amplitude of esophageal peristaltic waves	Esophageal manometry evaluates amplitude of esophageal peristalsis	preoperatively, 12 and 60 months after LRYGB	Yes
Secondary	Grade of esophagitis	Upper endoscopy is performed to assess the presence of esophagitis	preoperatively, 12 and 60 months after LRYGB	Yes
Secondary	Number of acidic reflux	number of acidic reflux at 24 hour pH impedance monitoring	preoperatively, 12 and 60 months after LRYGB	Yes