NCT03097887|Unknown
Omega Loop Gastric Bypass With And Without Anti-Reflux Sutures
Prospective, Randomized, Controlled Trial of Omega Loop Gastric Bypass With and Without Anti-reflux Sutures - a Pilot Study
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Prospective, Randomized, Controlled Trial of Omega Loop Gastric Bypass With and Without Anti-reflux Sutures - a Pilot Study
Sponsor study identifier
interventional
100
1 country
1
Study Start
October 1, 2019
Actual (reported)Primary Completion
July 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This proposed trial is designed to answer the following questions: First, is biliary reflux to the distal esophagus present before OLGB and does it increase after the procedure? Second, does performing an OLGB with or without anti-reflux sutures make a difference in (biliary) reflux exposures of the distal esophagus? To answer these questions the investigators plan to perform a randomized, controlled trial involving two groups. Group A will undergo an OLGB without anti-reflux sutures and consists of 50 patients. Group B will receive an OLGB with anti-reflux sutures and also consists of 50 patients. Gastroscopic evaluation for inflammation and reflux will be performed before and one year after the operation utilizing multilevel intraluminal impedance pH-monitoring (MII-pH) and intragastric Bilitec 2000™. Furthermore, the study will be blinded to the patient. Long-term weight loss, the resolution of comorbidities and the incidence of surgical complications will serve as secondary endpoints. Follow-ups will be performed at 3, 6, and 12 months postoperatively to assess all primary and secondary goals.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 21, 2017
Actual (reported)March 31, 2017
Actual (reported)October 1, 2019
Actual (reported)July 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Bile Reflux
The primary goal of this study is to assess, whether the choice of method (OLGB with or without anti-reflux sutures) affects the occurrence or severity of biliary reflux to the gastric pouch. Biliary exposure will therefore be assessed before and 12 months after the operation utilizing multilevel intraluminal impedance pH-monitoring (MII-pH) and intragastric Bilitec 2000™.
1 year
Bile Reflux
The primary goal of this study is to assess, whether the choice of method (OLGB with or without anti-reflux sutures) affects the occurrence or severity of biliary reflux to the gastric pouch. Extensive biopsies of the gastric pouch and gastroesophageal junction will be taken to prove histological changes due to biliary reflux.
1 year
Inflammation
1 year
Weight loss
1 year
BMI loss
1 year
Complications by point in time/stage
1 year
Complications by severity
1 year
Omega Loop Gastric Bypass with anti-reflux sutures using V-Loc sewing device. Biliary reflux measured using Bilitec 2000™.
Omega Loop Gastric Bypass without anti-reflux sutures. Biliary reflux measured using Bilitec 2000™.
Bariatric/metabolic surgical procedure
The Bilitec 2000™ device will be used to measure the intensity of biliary reflux in the pouch.
Medical University Vienna
Vienna, State of Vienna, 1090, Austria
Gerhard Prager, Univ. Prof.
Vienna Medical University
First Submitted
March 21, 2017
First Posted
March 31, 2017
Study Start
October 1, 2019
Actual (reported)Primary Completion
July 1, 2021
Estimated (date passed)Associations Among Serum and Gastric Juice Bile Acid Profile, Bile Acid-microbiota Cross-talk in Stomach and the Development of Gastric Cancer
Sewing device to perform the anti-reflux sutures.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 2, 2020
Record last verified: 2020-09
Analysis will be performed on anonymized data only. A list cross-linking the patient number to the name will be kept secure and is only available to the principal researcher. Written informed consent will be kept for 15 years.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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