Skip to content

Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05486169
Acronym
SLEEFLUX
Enrollment
50
Registered
2022-08-03
Start date
2022-09-01
Completion date
2023-08-31
Last updated
2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux, Obesity

Keywords

Gastroesophageal Reflux Disease, GERD, Obesity Surgery, Sleeve gastrectomy

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.

Interventions

PROCEDURESleeve Gastrectomy

surgery of laparoscopic sleeve gastrectomy

Sponsors

National Science Centre, Poland
CollaboratorOTHER_GOV
University of Warmia and Mazury in Olsztyn
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
gastroesophageal reflux after sleeve gastrectomy6 monthsThe 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

MeasureTime frameDescription
outcomes of sleeve gastrectomy6 monthsEach patient would have their body weight measured and asked about the resolution of comorbidities during the control visit six months after surgery

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026