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Enrolling by Invitation

NCT Number: NCT07711912

POLAR-STUDY: Polish AntiReflux Study

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Warmia and Mazury

Olsztyn, Warminsko-mazusrkie, 10-045, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prospective Clinical Observation and Follow-up

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Need for reintervention

    Time frame: 12 months after surgery

    Requirement for surgical or endoscopic reintervention related to antireflux surgery.

  4. Variation in surgical management

    Time frame: Baseline

    Distribution of indications for surgery, preoperative diagnostic tests, and surgical techniques used across participating centers.

Sponsors and collaborators

Lead sponsor

University of Warmia and Mazury in Olsztyn

Other

Registry information

Official study title

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

Acronym: POLAR

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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