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NCT05486169: SLEEFLUX

Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy

Completed NA Last updated 3 January 2024
What this trial tests

NA trial testing Sleeve Gastrectomy in Gastroesophageal Reflux in 50 participants. Completed in 31 August 2023.

Timeline
1 September 2022
Primary endpoint
31 July 2023
31 August 2023

Quick facts

Lead sponsorUniversity of Warmia and Mazury in Olsztyn
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposescreening
Enrollment50
Start date1 September 2022
Primary completion31 July 2023
Estimated completion31 August 2023
Sites1 location across Poland

Drugs / interventions tested

Conditions studied

Sponsor

University of Warmia and Mazury in Olsztyn

Who can join

18 and older, any sex, with Gastroesophageal Reflux or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The real occurrence of gastroesophageal reflux disease after sleeve gastrectomy - a prospective pH-monitoring study.
    Dowgiałło-Gornowicz N, Lech P. · · 2024 · cited 3× · PMID 38973794 · DOI 10.5114/wiitm.2024.138521
  2. Systematic mapping of registered interventional studies addressing the top 10 research priorities in Barrett's oesophagus and gastro-oesophageal reflux disease.
    Gamakaranage C, Ratcliffe E, Britton J, Butler T, et al · · 2025 · PMID 40527525 · DOI 10.1136/bmjgast-2025-001738

Verify or expand the search:

Other trials of Sleeve Gastrectomy

Trials testing the same drug.

Other recruiting trials for Gastroesophageal Reflux

Currently open trials in the same condition.

Other University of Warmia and Mazury in Olsztyn trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05486169.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing