Reflux Disease, Gastro-EsophagealPOLARNCT07711912
POLAR-STUDY: Polish AntiReflux Study
An observational study of Reflux Disease, Gastro-Esophageal, run by University of Warmia and Mazury in Olsztyn at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reflux Disease, Gastro-Esophageal
- What is being tested?
- Prospective Clinical Observation and Follow-up
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2026to 31 Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with gastroesophageal reflux disease (GERD) undergoing elective antireflux surgery at participating surgical centers across Poland. Consecutive eligible patients meeting the inclusion criteria will be prospectively enrolled. All diagnostic evaluation, surgical treatment, and postoperative follow-up will be performed according to the routine clinical practice of each participating center. The study is observational and does not alter standard patient management. Demographic, clinical, operative, and follow-up data will be collected to evaluate current surgical practice and treatment outcomes after antireflux surgery.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
University of Warmia and Mazury
Olsztyn, Warminsko-mazusrkie, 10-045
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Reflux Disease, Gastro-Esophageal
- Being tested
- Prospective Clinical Observation and Follow-up
- Keywords
- reflux, GERD, Nissen fundoplication, antireflux surgery
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective Clinical Observation and Follow-upOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Prospective Clinical Observation and Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
GERD symptom improvement at 12 months
Improvement in gastroesophageal reflux disease symptoms 12 months after antireflux surgery, assessed using the validated GERD-Health-Related Quality of Life (GERD-HRQL) questionnaire.
Measured: Baseline and 12 months after surgery
Secondary outcomes (4)
Change in health-related quality of life
Change in health-related quality of life measured using the RAND-36 questionnaire.
Measured: Baseline and 12 months after surgery
30-day postoperative complications
Incidence and severity of postoperative complications occurring within 30 days after antireflux surgery, classified according to the Clavien-Dindo classification.
Measured: 30 days after surgery
Need for reintervention
Requirement for surgical or endoscopic reintervention related to antireflux surgery.
Measured: 12 months after surgery
Variation in surgical management
Distribution of indications for surgery, preoperative diagnostic tests, and surgical techniques used across participating centers.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Mar 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Reflux Disease, Gastro-EsophagealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Warmia and Mazury in Olsztyn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalia Dowgiałło-Gornowicz, MD, PhD, University of Warmia and Mazury in Olsztyn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711912
- Sponsor's protocol ID
- 4/2026
- Acronym
- POLAR
- Status last verified
- Jan 2026
- First submitted
- 13 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20725747Katz 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.
PubMed 34807007Dowgiallo-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.
PubMed 30002752
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POLAR-STUDY: Polish AntiReflux Study - A Prospective Multicenter Observational Study of Antireflux Surgery in Poland
- ClinicalTrials.gov ID
- NCT07711912
- Acronym / sponsor ID
- POLAR / 4/2026
- Conditions
- Reflux Disease, Gastro-Esophageal
- Keywords
- reflux, GERD, Nissen fundoplication, antireflux surgery
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Warmia and Mazury in OlsztynUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults Undergoing Antireflux Surgery | – | Other: Prospective Clinical Observation and Follow-upAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with gastroesophageal reflux disease (GERD) undergoing elective antireflux surgery at participating surgical centers across Poland. Consecutive eligible patients meeting the inclusion criteria will be prospectively enrolled. All diagnostic evaluation, surgical treatment, and postoperative follow-up will be performed according to the routine clinical practice of each participating center. The study is observational and does not alter standard patient management. Demographic, clinical, operative, and follow-up data will be collected to evaluate current surgical practice and treatment outcomes after antireflux surgery.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective Clinical Observation and Follow-upParticipants 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. | Other | Adults Undergoing Antireflux Surgery |
Primary outcome
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.
4 secondary outcomes
Change in health-related quality of life
Time frame: Baseline and 12 months after surgery
30-day postoperative complications
Time frame: 30 days after surgery
Need for reintervention
Time frame: 12 months after surgery
Variation in surgical management
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Background: PubMed 20725747Stefanidis 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.
- Background: PubMed 34807007Katz 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.
- Background: PubMed 30002752Dowgiallo-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.
- Individual participant dataSharing planned: No
Related trials for Reflux Disease, Gastro-Esophageal
RecruitingObservational study
Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Zastaprazan Citrate
Erosive Gastroesophageal Reflux Disease
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Phrenoesophageal Ligament Reconstruction With Mesh
Hiatus Hernia, Gastreoesophageal Reflux Disease
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Enrolling by invitation
Endoscopic Treatment of Gastroesophageal Reflux Disease
Gastro Esophageal Reflux Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reflux Disease, Gastro-Esophageal, run by University of Warmia and Mazury in Olsztyn at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GERD symptom improvement at 12 months (time frame: Baseline and 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07711912, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.