Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy (SLEEFLUX)

January 1, 2024 updated by: Natalia Dowgiałło-Gornowicz, MD, PhD, University of Warmia and Mazury in Olsztyn

Gastroesophageal Reflux Disease in Patients Before and After Laparoscopic Sleeve Gastrectomy - pH-impedance Monitoring

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Olsztyn, Poland, 10-045
        • UWM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gastroesophageal reflux after sleeve gastrectomy
Time Frame: 6 months
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
outcomes of sleeve gastrectomy
Time Frame: 6 months
Each patient would have their body weight measured and asked about the resolution of comorbidities during the control visit six months after surgery
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Warmia and Mazury in Olsztyn

Collaborators

National Science Centre, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

July 30, 2022

First Submitted That Met QC Criteria

August 2, 2022

First Posted (Actual)

August 3, 2022

Study Record Updates

Last Update Posted (Actual)

January 3, 2024

Last Update Submitted That Met QC Criteria

January 1, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/06/X/NZ5/00007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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