POLAR-STUDY: Polish AntiReflux Study

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• GERD symptom improvement at 12 months [Срок оценки: Baseline and 12 months after surgery]

Вторичные конечные точки (4)

• Change in health-related quality of life [Срок оценки: Baseline and 12 months after surgery]
• 30-day postoperative complications [Срок оценки: 30 days after surgery]
• Need for reintervention [Срок оценки: 12 months after surgery]
• Variation in surgical management [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Польша · 1 центр

• University of Warmia and Mazury — Olsztyn

Публикации

• Stefanidis D, Hope WW, Kohn GP, Reardon PR, Richardson WS, Fanelli RD; SAGES Guidelines Committee. Guidelines for surgical treatment of gastroesophageal reflux disease. Surg Endosc. 2010 Nov;24(11):2647-69. doi: 10.1007/s00464-010-1267-8. Epub 2010 Aug 20. No abstract available. PMID 20725747
• Katz PO, Dunbar KB, Schnoll-Sussman FH, Greer KB, Yadlapati R, Spechler SJ. ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease. Am J Gastroenterol. 2022 Jan 1;117(1):27-56. doi: 10.14309/ajg.0000000000001538. PMID 34807007
• Dowgiallo-Wnukiewicz N, Frask A, Lech P, Michalik M. Study of the prevalence of gastroesophageal reflux symptoms and the role of each in relation to the GERD Impact Scale, based on a population of patients admitted for laparoscopic surgery compared to a control group. Wideochir Inne Tech Maloinwazyjne. 2018 Jun;13(2):199-211. doi: 10.5114/wiitm.2018.75909. Epub 2018 May 22. PMID 30002752

Идентификаторы

NCT: NCT07711912 · 4/2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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