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POLAR-STUDY: Polish AntiReflux Study (POLAR)

13. juli 2026 opdateret af: Natalia Dowgiałło-Gornowicz, MD, PhD, University of Warmia and Mazury in Olsztyn

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

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.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Gastroesophageal reflux disease (GERD) is one of the most common gastrointestinal disorders worldwide and is associated with impaired quality of life and an increased risk of long-term complications. Although antireflux surgery is an established treatment option for appropriately selected patients, considerable variation exists in patient selection, preoperative diagnostic work-up, surgical techniques, and postoperative management between centers.

POLAR-STUDY (Polish AntiReflux Study) is a prospective, multicenter observational study designed to evaluate the real-world practice of antireflux surgery in Poland. Consecutive adult patients undergoing surgical treatment for GERD at participating surgical centers will be enrolled. The study is observational and will not interfere with routine diagnostic or therapeutic management.

Clinical data collected during routine care will include patient demographics, medical history, preoperative investigations (including upper gastrointestinal endoscopy, esophageal pH monitoring, and high-resolution manometry when performed), indications for surgery, operative technique, and perioperative outcomes. Follow-up assessments will be conducted at 30 days and 12 months after surgery to evaluate reflux symptom control, quality of life, postoperative complications, and the need for reintervention.

The primary objective is to characterize contemporary antireflux surgical practice in Poland and to identify factors associated with successful surgical outcomes. The results are expected to provide nationwide real-world evidence that may contribute to optimizing patient selection, standardizing perioperative management, and improving the quality of surgical care for patients with GERD.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Polen
    • Warminsko-mazusrkie
      • Olsztyn, Warminsko-mazusrkie, Polen, 10-045
        • University of Warmia and Mazury

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adult patients with gastroesophageal reflux disease (GERD) undergoing elective antireflux surgery at participating surgical centers across Poland. Consecutive eligible patients meeting the inclusion criteria will be prospectively enrolled. All diagnostic evaluation, surgical treatment, and postoperative follow-up will be performed according to the routine clinical practice of each participating center. The study is observational and does not alter standard patient management. Demographic, clinical, operative, and follow-up data will be collected to evaluate current surgical practice and treatment outcomes after antireflux surgery.

Beskrivelse

Inclusion Criteria:

  • Age 18 years or older
  • Diagnosis of gastroesophageal reflux disease
  • Qualification for antireflux surgery according to the routine clinical practice of the participating center
  • Planned antireflux surgical procedure at a participating center
  • Ability to provide written informed consent
  • Willingness to participate in postoperative follow-up

Exclusion Criteria:

  • Age younger than 18 years
  • Lack of qualification for antireflux surgery
  • Inability to provide informed consent
  • Refusal to participate in the study
  • Inability to complete the planned follow-up assessments
  • Emergency surgery or surgery performed for an indication other than gastroesophageal reflux disease

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Adults Undergoing Antireflux Surgery
Adult patients with gastroesophageal reflux disease (GERD) undergoing antireflux surgery at participating centers in Poland. Participants will receive standard diagnostic evaluation, surgical treatment, and postoperative follow-up according to routine clinical practice. The study is observational and does not alter standard patient management. Clinical, operative, and follow-up data will be collected prospectively to evaluate surgical practice and treatment outcomes.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
GERD symptom improvement at 12 months
Tidsramme: Baseline and 12 months after surgery
Improvement in gastroesophageal reflux disease symptoms 12 months after antireflux surgery, assessed using the validated GERD-Health-Related Quality of Life (GERD-HRQL) questionnaire.
Baseline and 12 months after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in health-related quality of life
Tidsramme: Baseline and 12 months after surgery
Change in health-related quality of life measured using the RAND-36 questionnaire.
Baseline and 12 months after surgery
30-day postoperative complications
Tidsramme: 30 days after surgery
Incidence and severity of postoperative complications occurring within 30 days after antireflux surgery, classified according to the Clavien-Dindo classification.
30 days after surgery
Need for reintervention
Tidsramme: 12 months after surgery
Requirement for surgical or endoscopic reintervention related to antireflux surgery.
12 months after surgery
Variation in surgical management
Tidsramme: Baseline
Distribution of indications for surgery, preoperative diagnostic tests, and surgical techniques used across participating centers.
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Warmia and Mazury in Olsztyn

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2026

Primær færdiggørelse (Anslået)

1. oktober 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

13. juli 2026

Først indsendt, der opfyldte QC-kriterier

13. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2026

Sidst verificeret

1. januar 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 4/2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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