Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05486169 |
| Other study ID # |
2022/06/X/NZ5/00007 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2022 |
| Est. completion date |
August 31, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
University of Warmia and Mazury in Olsztyn |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
