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Omega Loop Gastric Bypass With And Without Anti-Reflux Sutures

Primary Purpose

Bile Reflux

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Omega Loop Gastric Bypass
Bilitec 2000™
V-Loc
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bile Reflux focused on measuring Omega Loop Gastric Bypass, Reflux, Mini Gastric Bypass

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 20 and 70 years
  • Body Mass Index ≥ 35.0 kg/m2
  • Exclusion of psychological, endocrinological and anesthesiological contraindications
  • Willingness to be assigned to either of the two groups
  • Follow-up anticipation
  • Willingness to attend all follow-up visits
  • Written informed consent

Exclusion Criteria:

  • recent or ongoing cardiovascular event within the last 6 months (myocardial infarction, acute coronary syndrome, angioplasty or coronary bypass operation, insult),
  • pulmonary embolism or thrombophlebitis within the last 6 months, other bariatric procedures, e.g. gastric banding, Sleeve Gastrectomy, etc., cancer of various origins (exceptions: basal cell carcinoma or carcinoma in situ, disease-free over the last 5 years),
  • significant anemia or coagulopathy,
  • serum creatinin ≥ 1.5 mg/dl.,
  • serum bilirubin or phosphatase elevated or ALT above 3 times the upper limit, stomach, biliopancreatic operations, splenectomy or colon resections, gastric or duodenal ulcer within the last 6 months,
  • intraabdominal sepsis (except uncomplicated appendicitis or diverticulitis over 6 months prior to the study),
  • organ transplantations,
  • anamnestic HIV infection, active TBC, active malaria, chronic Hepatitis B or C, liver cirrhosis,
  • alcohol or drug addiction (except caffeine, nicotine) in history,
  • acute psychiatric disease interfering with the proposed trial,
  • other chronic disease which might interfere with the participation.

Also, patients who are pregnant or plan a pregnancy within the following two years as well as patients who have been included in another study, will be excluded.

Note: Exclusion can be performed by a study coordinator at any time.

Hiatal hernia is not considered an exclusion criterion in this study.

Sites / Locations

  • Medical University ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Anti-reflux sutures

No anti-reflux sutures

Arm Description

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™.

Outcomes

Primary Outcome Measures

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™.
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.

Secondary Outcome Measures

Inflammation
Assessing inflammation before and 12 months after surgery using gastroscopy with biopsy.
Weight loss
Measuring excess weight loss (EWL), to reveal any changes in patients' weight
BMI loss
Excess BMI loss (EBMIL), to reveal any changes in patients' BMI
Complications by point in time/stage
Early postoperative complications (occurring within 30 days) Late postoperative complications (occurring after 30 days)
Complications by severity
Moderate complications (not requiring additional surgical intervention) Severe complications (requiring surgical intervention)
Resolution of hyperlipidemia
Collecting evidence for the resolution of hyperlipidemia
Resolution of hypertension
Collecting evidence for the resolution of hypertension
Resolution of diabetes
Collecting evidence for the resolution of diabetes
Resolution of sleep apnea
Collecting evidence for the resolution of sleep apnea

Full Information

First Posted
March 21, 2017
Last Updated
September 1, 2020
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT03097887
Brief Title
Omega Loop Gastric Bypass With And Without Anti-Reflux Sutures
Official Title
Prospective, Randomized, Controlled Trial of Omega Loop Gastric Bypass With and Without Anti-reflux Sutures - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Obesity, and especially its comorbidities, has unarguably become the number one threat to human health in the modern world. Western lifestyle leads to an increased prevalence and thus to a higher mortality (i.e. due to cardiovascular diseases). The positive effects of gastric bypass surgery on excess weight loss and comorbidity resolution are well-known. In contrast to the standard laparoscopic Roux-en-Y Gastric Bypass (RYGB), a newer method, the laparoscopic Omega Loop Gastric Bypass (OLGB), has emerged over the past years. It is believed to be the simpler method involving only one anastomosis (instead of two) and therefore potentially reducing morbidity and mortality whilst maintaining comparable excess weight loss. However, since this new type of gastric bypass is similar to the former Billroth II resection (BII), the carcinoma risk is a concern. The OLGB is different from the BII resection in many ways. For instance, it involves creating an approximately 10 cm long narrow gastric pouch which could prevent the suspected underlying pathogenetic mechanism: biliary reflux to the gastric tube and subsequently to the esophagus. Biliary reflux is suspected to stimulate squamous esophageal cells and Barrett's epithelial cells to produce inflammatory mediators and therefore cause oxidative stress, DNA damage and apoptosis which might lead to adenocarcinoma. Worldwide, there are currently two different ways to perform an OLGB: with or without anti-reflux sutures, which involve sewing the biliopancreatic limb to the staple line of the pouch using V-Loc (non-absorbable) moving upwards as far as easily possible without creating any tension. 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Reflux
Keywords
Omega Loop Gastric Bypass, Reflux, Mini Gastric Bypass

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anti-reflux sutures
Arm Type
Active Comparator
Arm Description
Omega Loop Gastric Bypass with anti-reflux sutures using V-Loc sewing device. Biliary reflux measured using Bilitec 2000™.
Arm Title
No anti-reflux sutures
Arm Type
Active Comparator
Arm Description
Omega Loop Gastric Bypass without anti-reflux sutures. Biliary reflux measured using Bilitec 2000™.
Intervention Type
Procedure
Intervention Name(s)
Omega Loop Gastric Bypass
Other Intervention Name(s)
Mini Gastric Bypass, Single Anastomosis Gastric Bypass
Intervention Description
Bariatric/metabolic surgical procedure
Intervention Type
Device
Intervention Name(s)
Bilitec 2000™
Intervention Description
The Bilitec 2000™ device will be used to measure the intensity of biliary reflux in the pouch.
Intervention Type
Device
Intervention Name(s)
V-Loc
Intervention Description
Sewing device to perform the anti-reflux sutures.
Primary Outcome Measure Information:
Title
Bile Reflux
Description
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™.
Time Frame
1 year
Title
Bile Reflux
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Inflammation
Description
Assessing inflammation before and 12 months after surgery using gastroscopy with biopsy.
Time Frame
1 year
Title
Weight loss
Description
Measuring excess weight loss (EWL), to reveal any changes in patients' weight
Time Frame
1 year
Title
BMI loss
Description
Excess BMI loss (EBMIL), to reveal any changes in patients' BMI
Time Frame
1 year
Title
Complications by point in time/stage
Description
Early postoperative complications (occurring within 30 days) Late postoperative complications (occurring after 30 days)
Time Frame
1 year
Title
Complications by severity
Description
Moderate complications (not requiring additional surgical intervention) Severe complications (requiring surgical intervention)
Time Frame
1 year
Title
Resolution of hyperlipidemia
Description
Collecting evidence for the resolution of hyperlipidemia
Time Frame
1 year
Title
Resolution of hypertension
Description
Collecting evidence for the resolution of hypertension
Time Frame
1 year
Title
Resolution of diabetes
Description
Collecting evidence for the resolution of diabetes
Time Frame
1 year
Title
Resolution of sleep apnea
Description
Collecting evidence for the resolution of sleep apnea
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 20 and 70 years Body Mass Index ≥ 35.0 kg/m2 Exclusion of psychological, endocrinological and anesthesiological contraindications Willingness to be assigned to either of the two groups Follow-up anticipation Willingness to attend all follow-up visits Written informed consent Exclusion Criteria: recent or ongoing cardiovascular event within the last 6 months (myocardial infarction, acute coronary syndrome, angioplasty or coronary bypass operation, insult), pulmonary embolism or thrombophlebitis within the last 6 months, other bariatric procedures, e.g. gastric banding, Sleeve Gastrectomy, etc., cancer of various origins (exceptions: basal cell carcinoma or carcinoma in situ, disease-free over the last 5 years), significant anemia or coagulopathy, serum creatinin ≥ 1.5 mg/dl., serum bilirubin or phosphatase elevated or ALT above 3 times the upper limit, stomach, biliopancreatic operations, splenectomy or colon resections, gastric or duodenal ulcer within the last 6 months, intraabdominal sepsis (except uncomplicated appendicitis or diverticulitis over 6 months prior to the study), organ transplantations, anamnestic HIV infection, active TBC, active malaria, chronic Hepatitis B or C, liver cirrhosis, alcohol or drug addiction (except caffeine, nicotine) in history, acute psychiatric disease interfering with the proposed trial, other chronic disease which might interfere with the participation. Also, patients who are pregnant or plan a pregnancy within the following two years as well as patients who have been included in another study, will be excluded. Note: Exclusion can be performed by a study coordinator at any time. Hiatal hernia is not considered an exclusion criterion in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel M Felsenreich, Dr.
Phone
+43 1 40400
Ext
56220
Email
moritz.felsenreich@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Gerhard Prager, Univ. Prof.
Phone
+43 1 40400
Ext
54320
Email
gerhard.prager@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Prager, Univ. Prof.
Organizational Affiliation
Vienna Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Medical University Vienna
City
Wien
State/Province
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Moritz Felsenreich, Dr.
Phone
00436767016111
Ext
00436767016111
Email
moritz.felsenreich@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Daniel Moritz Felsenreich
Phone
00436767016111
Ext
00436767016111
Email
moritz.felsenreich@meduniwien.ac.at

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.

Learn more about this trial

Omega Loop Gastric Bypass With And Without Anti-Reflux Sutures

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