POLAR-STUDY: Polish AntiReflux Study (POLAR)
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní místa
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Warminsko-mazusrkie
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Olsztyn, Warminsko-mazusrkie, Polsko, 10-045
- University of Warmia and Mazury
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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GERD symptom improvement at 12 months
Časové okno: Baseline and 12 months after surgery
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Improvement in gastroesophageal reflux disease symptoms 12 months after antireflux surgery, assessed using the validated GERD-Health-Related Quality of Life (GERD-HRQL) questionnaire.
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Baseline and 12 months after surgery
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in health-related quality of life
Časové okno: Baseline and 12 months after surgery
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Change in health-related quality of life measured using the RAND-36 questionnaire.
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Baseline and 12 months after surgery
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30-day postoperative complications
Časové okno: 30 days after surgery
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Incidence and severity of postoperative complications occurring within 30 days after antireflux surgery, classified according to the Clavien-Dindo classification.
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30 days after surgery
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Need for reintervention
Časové okno: 12 months after surgery
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Requirement for surgical or endoscopic reintervention related to antireflux surgery.
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12 months after surgery
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Variation in surgical management
Časové okno: Baseline
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Distribution of indications for surgery, preoperative diagnostic tests, and surgical techniques used across participating centers.
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Baseline
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Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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Klinické studie na Prospective Clinical Observation and Follow-up
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Johns Hopkins UniversityPatient-Centered Outcomes Research Institute; Children's Hospital of Philadelphia a další spolupracovníciNáborSebevražda, pokus | Sebevražda | Sebevražedné myšlenky | Prevence sebevraždSpojené státy