GERDNCT03536169
Utilization of Anti-reflux Treatment and Course of Illness Leading to Reoperation
An observational study of GERD and Fundoplication, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate course of illness leading to reoperation after primary anti-reflux surgery and investigate the utilization of anti-reflux treatment, both medical and surgical, in the period 2000-2017 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD, Fundoplication
- How many people
- 3,717 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2018to 1 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The population is defined as all adult Danish patients undergoing anti-reflux surgery (Nomesco: KJBC00, KJBC01, KJBC02, KJBW96, KJBW97) from 2000-2017 identified from The National Patient Register.
Who may be able to join
- All adult Danish patients undergoing anti-reflux surgery (Nomesco: KJBC00, KJBC01, KJBC02, KJBW96, KJBW97) from 2000-2017 identified from The National Patient Register.
Who cannot join
- Any diagnosis of gastrointestinal cancer during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utilization of Anti-reflux Treatment and Course of Illness Leading to Reoperation After Anti-reflux Surgery in a National Population-based Cohort
The purpose of this study is to investigate course of illness leading to reoperation after primary anti-reflux surgery and investigate the utilization of anti-reflux treatment, both medical and surgical, in the period 2000-2017
Read the detailed description
Aim The purpose of this study is to investigate course of illness leading to reoperation after primary anti-reflux surgery and investigate the utilization of anti-reflux treatment, both medical and surgical, in the period 2000-2017
Methods The study is a two-part register-based cohort study based on data from The National Patient Registry, The Civic Registry and Danish Anaesthesia Database in the period 1996-2017. The two individual parts of the study concerns the same population.
The population is defined as all adult Danish patients undergoing anti-reflux surgery (Nomesco: KJBC00, KJBC01, KJBC02, KJBW96, KJBW97) from 2000-2017 identified from The National Patient Register.
Age, sex, Charlson Comorbidity Index at date of surgery and length of stay in relation to any surgery and any surgical or endoscopic procedure performed after anti-reflux surgery (including diagnosis 30 days postoperatively to establish possible morbidity) are derived from the National Patient Registry.
ASA-score, weight, height, use of alcohol or tobacco and priority of any surgery (emergency or planned) during the study period are retrieved from The Danish Anaesthesia Database. From the Civic Register, data on mortality in the study period are retrieved.
Information on the use of pharmacological treatment for gastroesophageal reflux disease on population level is retrieved from MEDSTAT and data on population size on population level are retrieved from Statistics Denmark.
Statistical analysis
- Course of illness leading to reoperative anti-reflux surgery Data will be analyzed using STATA15. Descriptive analysis of age, sex, comorbidity (Charlson Comorbidity Index, ASA-score, BMI, alcohol/tobacco use), complications to surgery, rate of endoscopic dilation and mortality comparing patients with only primary anti-reflux surgery and patients with reoperation during the study period, will be performed using Student's t-test, Chi2-test and Mann-Whitney-U test. Logistic regression will be performed with reoperation (laparoscopic, open or other) as primary outcome and age, sex, comorbidity (Charlson Comorbidity Index, ASA-score, BMI, alcohol/tobacco use), complications to surgery and endoscopic or surgical procedure during study period as independent variables. If the number of patients is sufficient, subanalysis will be performed with emergency reoperation as dependent variable/outcome. Secondary analysis will be performed using Cox-regression investigating time to reoperation with age, sex, comorbidity (Charlson Comorbidity Index, ASA-score, BMI, alcohol/tobacco use), complications to surgery and endoscopic or surgical procedure during study period as independent variables.
- Utilization of treatment of gastroesophageal reflux disease. The rate of anti-reflux surgery per 100.000 inhabitants for each year during the study period will be calculated using census data from Statistics Denmark. From MEDSAT the rate of use of pharmacological anti-reflux treatment per 100.000 inhabitants will be calculated using abovementioned census-data. Trends in the utilization of surgery are investigated with trend-analysis in the form of Poisson-regression alternatively negative binominal regression.
- Conditions
- GERD, Fundoplication
- Medical subject headings
- Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation
Any reoperative anti-reflux surgery
Measured: 2000-2017 (Maximum of 17 years follow-up, minimum of 1 year)
Rate of anti-reflux surgery
Based on Danish census-data
Measured: 2000-2017
Rate of pharmacological anti-reflux treatment
Based on Danish census-data
Measured: 2000-2017
Secondary outcomes (1)
Emergency reoperative anti-reflux surgery
Rate of reoperative surgery performed as emergency procedure
Measured: 2000-2017(Maximum of 17 years follow-up, minimum of 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start1 Jun 2018
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 3,717 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense Patient Data Explorative Network, Kolding Sygehus
- Responsible party
- Principal investigator, Jonas Sanberg Jensen, University of Southern Denmark
- Investigators
- Jonas S Jensen, MD, Principal investigator, Department of Surgery, Kolding Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536169
- Sponsor's protocol ID
- JSJ_OP446
- Status last verified
- Aug 2020
- First submitted
- 9 May 2018
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data are by Danish law no allowed to be shared without specific authorization prior to study initiation.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Anti-reflux Treatment and Course of Illness Leading to Reoperation After Anti-reflux Surgery in a National Population-based Cohort
- ClinicalTrials.gov ID
- NCT03536169
- Acronym / sponsor ID
- JSJ_OP446
- Conditions
- GERD, Fundoplication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,717 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense Patient Data Explorative Network, Kolding Sygehus
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 24 May 2018 (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 purpose of this study is to investigate course of illness leading to reoperation after primary anti-reflux surgery and investigate the utilization of anti-reflux treatment, both medical and surgical, in the period 2000-2017
Detailed description
Aim The purpose of this study is to investigate course of illness leading to reoperation after primary anti-reflux surgery and investigate the utilization of anti-reflux treatment, both medical and surgical, in the period 2000-2017
Methods The study is a two-part register-based cohort study based on data from The National Patient Registry, The Civic Registry and Danish Anaesthesia Database in the period 1996-2017. The two individual parts of the study concerns the same population.
The population is defined as all adult Danish patients undergoing anti-reflux surgery (Nomesco: KJBC00, KJBC01, KJBC02, KJBW96, KJBW97) from 2000-2017 identified from The National Patient Register.
Age, sex, Charlson Comorbidity Index at date of surgery and length of stay in relation to any surgery and any surgical or endoscopic procedure performed after anti-reflux surgery (including diagnosis 30 days postoperatively to establish possible morbidity) are derived from the National Patient Registry.
ASA-score, weight, height, use of alcohol or tobacco and priority of any surgery (emergency or planned) during the study period are retrieved from The Danish Anaesthesia Database. From the Civic Register, data on mortality in the study period are retrieved.
Information on the use of pharmacological treatment for gastroesophageal reflux disease on population level is retrieved from MEDSTAT and data on population size on population level are retrieved from Statistics Denmark.
Statistical analysis
- Course of illness leading to reoperative anti-reflux surgery Data will be analyzed using STATA15. Descriptive analysis of age, sex, comorbidity (Charlson Comorbidity Index, ASA-score, BMI, alcohol/tobacco use), complications to surgery, rate of endoscopic dilation and mortality comparing patients with only primary anti-reflux surgery and patients with reoperation during the study period, will be performed using Student's t-test, Chi2-test and Mann-Whitney-U test. Logistic regression will be performed with reoperation (laparoscopic, open or other) as primary outcome and age, sex, comorbidity (Charlson Comorbidity Index, ASA-score, BMI, alcohol/tobacco use), complications to surgery and endoscopic or surgical procedure during study period as independent variables. If the number of patients is sufficient, subanalysis will be performed with emergency reoperation as dependent variable/outcome. Secondary analysis will be performed using Cox-regression investigating time to reoperation with age, sex, comorbidity (Charlson Comorbidity Index, ASA-score, BMI, alcohol/tobacco use), complications to surgery and endoscopic or surgical procedure during study period as independent variables.
- Utilization of treatment of gastroesophageal reflux disease. The rate of anti-reflux surgery per 100.000 inhabitants for each year during the study period will be calculated using census data from Statistics Denmark. From MEDSAT the rate of use of pharmacological anti-reflux treatment per 100.000 inhabitants will be calculated using abovementioned census-data. Trends in the utilization of surgery are investigated with trend-analysis in the form of Poisson-regression alternatively negative binominal regression.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population is defined as all adult Danish patients undergoing anti-reflux surgery (Nomesco: KJBC00, KJBC01, KJBC02, KJBW96, KJBW97) from 2000-2017 identified from The National Patient Register.
Key inclusion criteria (1 listed)
- All adult Danish patients undergoing anti-reflux surgery (Nomesco: KJBC00, KJBC01, KJBC02, KJBW96, KJBW97) from 2000-2017 identified from The National Patient Register.
Key exclusion criteria (1 listed)
- Any diagnosis of gastrointestinal cancer during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reoperation
Time frame: 2000-2017 (Maximum of 17 years follow-up, minimum of 1 year)
Any reoperative anti-reflux surgery
Rate of anti-reflux surgery
Time frame: 2000-2017
Based on Danish census-data
Rate of pharmacological anti-reflux treatment
Time frame: 2000-2017
Based on Danish census-data
1 secondary outcome
Emergency reoperative anti-reflux surgery
Time frame: 2000-2017(Maximum of 17 years follow-up, minimum of 1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Individual participant dataSharing planned: No. Individual patient data are by Danish law no allowed to be shared without specific authorization prior to study initiation.
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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. This study is not recruiting at the moment.
Jonas S Jensen, MD principal investigator
Department of Surgery, Kolding Hospital
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 GERD and Fundoplication, run by University of Southern Denmark at 1 site in Denmark.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Aug 2020. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reoperation (time frame: 2000-2017 (Maximum of 17 years follow-up, minimum of 1 year)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2020.