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Utilization of Anti-reflux Treatment and Course of Illness Leading to Reoperation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03536169
Recruitment Status : Completed
First Posted : May 24, 2018
Last Update Posted : August 4, 2020
Sponsor:
Collaborators:
Odense Patient Data Explorative Network
Kolding Sygehus
Information provided by (Responsible Party):
Jonas Sanberg Jensen, University of Southern Denmark

Brief 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

Condition or disease
GERD Fundoplication

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

  1. 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.

  2. 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.

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Study Type : Observational
Actual Enrollment : 3717 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Utilization of Anti-reflux Treatment and Course of Illness Leading to Reoperation After Anti-reflux Surgery in a National Population-based Cohort
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : August 1, 2020
Actual Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD




Primary Outcome Measures :
  1. Reoperation [ Time Frame: 2000-2017 (Maximum of 17 years follow-up, minimum of 1 year) ]
    Any reoperative anti-reflux surgery

  2. Rate of anti-reflux surgery [ Time Frame: 2000-2017 ]
    Based on Danish census-data

  3. Rate of pharmacological anti-reflux treatment [ Time Frame: 2000-2017 ]
    Based on Danish census-data


Secondary Outcome Measures :
  1. Emergency reoperative anti-reflux surgery [ Time Frame: 2000-2017(Maximum of 17 years follow-up, minimum of 1 year) ]
    Rate of reoperative surgery performed as emergency procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • All adult Danish patients undergoing anti-reflux surgery (Nomesco: KJBC00, KJBC01, KJBC02, KJBW96, KJBW97) from 2000-2017 identified from The National Patient Register.

Exclusion Criteria:

  • Any diagnosis of gastrointestinal cancer during the study period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536169


Locations
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Denmark
Department of Surgery, Kolding Hospital
Kolding, Denmark
Sponsors and Collaborators
University of Southern Denmark
Odense Patient Data Explorative Network
Kolding Sygehus
Investigators
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Principal Investigator: Jonas S Jensen, MD Department of Surgery, Kolding Hospital
  Study Documents (Full-Text)

Documents provided by Jonas Sanberg Jensen, University of Southern Denmark:
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Responsible Party: Jonas Sanberg Jensen, MD, Ph.d.-student, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03536169    
Other Study ID Numbers: JSJ_OP446
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual patient data are by Danish law no allowed to be shared without specific authorization prior to study initiation.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease Progression
Disease Attributes
Pathologic Processes