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ENROLLING BY INVITATION
NCT07711912

POLAR-STUDY: Polish AntiReflux Study

Sponsor: University of Warmia and Mazury in Olsztyn

View on ClinicalTrials.gov

Summary

The goal of this observational study is to evaluate the current practice and outcomes of surgical treatment for gastroesophageal reflux disease (GERD) in adults undergoing antireflux surgery in Poland. The study aims to identify factors associated with successful treatment and postoperative outcomes in routine clinical practice. The main questions it aims to answer are: What are the current indications, preoperative diagnostic pathways, and surgical techniques used for antireflux surgery in Poland? Which patient- and procedure-related factors are associated with symptom resolution, improved quality of life, and postoperative outcomes following antireflux surgery? Participants will: undergo antireflux surgery according to routine clinical practice at participating centers; undergo standard preoperative diagnostic evaluation, including investigations performed as part of routine care; complete clinical and quality-of-life assessments before surgery and during follow-up at 30 days and 12 months after surgery.

Official title: POLAR-STUDY: Polish AntiReflux Study - A Prospective Multicenter Observational Study of Antireflux Surgery in Poland

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2026-03-01

Completion Date

2027-12-31

Last Updated

2026-07-17

Healthy Volunteers

No

Interventions

OTHER

Prospective Clinical Observation and Follow-up

Participants will be followed prospectively as part of routine clinical care after antireflux surgery. The study does not modify standard diagnostic or therapeutic management. Clinical, operative, and follow-up data, including preoperative evaluation, perioperative outcomes, reflux symptoms, quality of life, postoperative complications, and the need for reintervention, will be collected at baseline, 30 days, and 12 months after surgery.

Locations (1)

University of Warmia and Mazury

Olsztyn, Warminsko-mazusrkie, Poland