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CompletedNCT05486169SLEEFLUXUpdated Jan 3, 2024

Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy

An interventional study of Sleeve Gastrectomy in Gastroesophageal Reflux and Obesity, sponsored by University of Warmia and Mazury in Olsztyn. Completed at 1 site in Poland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-03.

Sponsored by University of Warmia and Mazury in Olsztyn · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Gastroesophageal Reflux
  • Obesity

Keywords

  • Gastroesophageal Reflux Disease
  • GERD
  • Obesity Surgery
  • Sleeve gastrectomy
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 50 is below the median of 72 across 711 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

University of Warmia and Mazury in Olsztyn is the lead sponsor of 12 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • symptoms of gastroesophageal reflux disease before the surgery
  • pathological changes in gastroscopy before the surgery
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Interventions

  • ProcedureSleeve Gastrectomy

    surgery of laparoscopic sleeve gastrectomy

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

Secondary outcomes

  1. 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

    Time frame: 6 months

07

Study locations

1 site
  • UWM
    Olsztyn, 10-045, Poland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05486169
Lead sponsor
University of Warmia and Mazury in Olsztyn
Collaborators
National Science Centre, Poland
Responsible party
Natalia Dowgiałło-Gornowicz, MD, PhD (assistant professor, University of Warmia and Mazury in Olsztyn) — Principal investigator
First posted
Aug 3, 2022
Start date
Sep 1, 2022
Primary completion
Jul 31, 2023
Completion
Aug 31, 2023
Last update
Jan 3, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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