POLAR-STUDY: Polish AntiReflux Study (POLAR)

July 13, 2026 updated by: 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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GERD symptom improvement at 12 months
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in health-related quality of life
Time Frame: 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
Time Frame: 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
Time Frame: 12 months after surgery
Requirement for surgical or endoscopic reintervention related to antireflux surgery.
12 months after surgery
Variation in surgical management
Time Frame: Baseline
Distribution of indications for surgery, preoperative diagnostic tests, and surgical techniques used across participating centers.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Warmia and Mazury in Olsztyn

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

July 13, 2026

First Submitted That Met QC Criteria

July 13, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4/2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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