POLAR-STUDY: Polish AntiReflux Study - A Prospective Multicenter Observational Study of Antireflux Surgery in Poland
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- GERD symptom improvement at 12 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
GERD symptom improvement at 12 months
时间窗: 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.
次要结局
- Change in health-related quality of life(Baseline and 12 months after surgery)
- 30-day postoperative complications(30 days after surgery)
- Need for reintervention(12 months after surgery)
- Variation in surgical management(Baseline)
研究者
Natalia Dowgiałło-Gornowicz, MD, PhD
Prof. of UWM, MD, PhD
University of Warmia and Mazury in Olsztyn