Reflux Disease, Gastro-Esophageal
Conditions
Keywords
reflux, GERD, Nissen fundoplication, antireflux surgery
Brief summary
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.
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.
Interventions
OTHERProspective 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.
Sponsors
University of Warmia and Mazury in Olsztyn
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GERD symptom improvement at 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in health-related quality of life | Baseline and 12 months after surgery | Change in health-related quality of life measured using the RAND-36 questionnaire. |
| 30-day postoperative complications | 30 days after surgery | Incidence and severity of postoperative complications occurring within 30 days after antireflux surgery, classified according to the Clavien-Dindo classification. |
| Need for reintervention | 12 months after surgery | Requirement for surgical or endoscopic reintervention related to antireflux surgery. |
| Variation in surgical management | Baseline | Distribution of indications for surgery, preoperative diagnostic tests, and surgical techniques used across participating centers. |
Countries
Poland
Outcome results
None listed