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Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy (SLEEFLUX)

Primary Purpose

Gastroesophageal Reflux, Obesity

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Sleeve Gastrectomy
Sponsored by
University of Warmia and Mazury in Olsztyn
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Gastroesophageal Reflux focused on measuring Gastroesophageal Reflux Disease, GERD, Obesity Surgery, Sleeve gastrectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI above 40kg/m2
  • positive qualification process for laparoscopic sleeve gastrectomy

Exclusion Criteria:

  • symptoms of gastroesophageal reflux disease before the surgery
  • pathological changes in gastroscopy before the surgery

Sites / Locations

  • UWM

Outcomes

Primary Outcome Measures

gastroesophageal reflux after sleeve gastrectomy
The main aim of the study is to assess the frequency and quality of gastroesophageal reflux disease in patients six months after sleeve gastrectomy. The reflux will be measured in each patient using 24-hour pH-impedance testing

Secondary Outcome Measures

outcomes of sleeve gastrectomy
Each patient would have their body weight measured and asked about the resolution of comorbidities during the control visit six months after surgery

Full Information

First Posted
July 30, 2022
Last Updated
October 31, 2022
Sponsor
University of Warmia and Mazury in Olsztyn
Collaborators
National Science Centre, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT05486169
Brief Title
Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy
Acronym
SLEEFLUX
Official Title
Gastroesophageal Reflux Disease in Patients Before and After Laparoscopic Sleeve Gastrectomy - pH-impedance Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Warmia and Mazury in Olsztyn
Collaborators
National Science Centre, Poland

4. Oversight

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

5. Study Description

Brief Summary
The planned research is to analyze the occurrence of gastroesophageal reflux disease (GERD) before and after sleeve gastrectomy (SG). The study includes patients with BMI above 40 kg / m2 without symptoms of GERD before surgery and any pathological changes in gastroscopy. The day before the surgery, patients will be tested with impedance pH measurement. Thereafter, patients will undergo SG according to standard technique. As part of the follow-up 6 months after the surgery, the pH-measurement test with impedance again will be performed again for evaluation of the occurrence of GERD after surgery. It was planned to include 50 people in the study. The main aim of the study is to assess the frequency and quality of GERD in patients after SG.
Detailed Description
According to World Health Organization data, almost 15% of people in the world are obese, and this is constantly growing. According to the available literature, an effective method of observation long-term treatment that allows for the permanent cure of obesity is surgical treatment. Currently sleeve gastrectomy (SG) is the most commonly performed procedure in the world. There are numerous evidence of the effectiveness of surgery in treating obesity and comorbidities, however, came along with the increase in the number of procedures performed, controversy arises, including the occurrence of gastroesophageal reflux disease (GERD) after surgery. As a consequence, GERD can lead to esophageal cancer. This problem wants to be dealt with in this study. The planned research is to analyze the occurrence of GERD before and after SG. Down the study will include patients whose BMI is 40 kg / m2 and more who will be positive passed the qualification process for SG. The exclusion criteria are the occurrence of symptoms of GERD before surgery, pathological changes in gastroscopy - features of reflux oesophagitis, and the patient's lack of consent to participation in the study. On the eve of surgery, patients will be tested with impedance pH measurement. Is it non-invasive 24-hour examination consisting in measuring the pH and impedance of the esophagus allowing for the detection of reflux episodes and their accurate assessment - type, time. Currently this test is the gold standard for the diagnosis of GERD, including in patients asymptomatic. Thereafter, patients will undergo SG according to standard technique. As part of the follow-up 6 months after the surgery, the pH-measurement test with impedance again will be performed again for evaluation of the occurrence of GERD after surgery. It was planned to include 50 people in the study, which is good, satisfactory material for statistical analysis. The main aim of the study is to assess the frequency and quality of GERD in patients after SG. Yet published works on this issue define the occurrence of GERD mainly on on the basis of an interview with the patient or changes in the gastroscopy examination, which does not allow definitive definition of the disease incidence. Often, the mileage may be left to the patient asymptomatic - e.g. in the case of neutral reflux, and changes in endoscopic examination may not yet be visible. Thus, the only effective method to assess the occurrence of GERD is to perform a pH-measurement test with impedance. Moreover a group of 50 people subjected to the tests will make it possible to try to determine the predisposing factors to the occurrence of GERD after surgery, which will enable further the order of taking actions to prevent its occurrence. The results of the research will be presented on a thematic basis scientific conferences, then published in one of the renowned journals research in this field.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux, Obesity
Keywords
Gastroesophageal Reflux Disease, GERD, Obesity Surgery, Sleeve gastrectomy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Sleeve Gastrectomy
Intervention Description
surgery of laparoscopic sleeve gastrectomy
Primary Outcome Measure Information:
Title
gastroesophageal reflux after sleeve gastrectomy
Description
The main aim of the study is to assess the frequency and quality of gastroesophageal reflux disease in patients six months after sleeve gastrectomy. The reflux will be measured in each patient using 24-hour pH-impedance testing
Time Frame
6 months
Secondary Outcome Measure Information:
Title
outcomes of sleeve gastrectomy
Description
Each patient would have their body weight measured and asked about the resolution of comorbidities during the control visit six months after surgery
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI above 40kg/m2 positive qualification process for laparoscopic sleeve gastrectomy Exclusion Criteria: symptoms of gastroesophageal reflux disease before the surgery pathological changes in gastroscopy before the surgery
Facility Information:
Facility Name
UWM
City
Olsztyn
ZIP/Postal Code
10-045
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy

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