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

GERD Clinical Trial

Official title:

Utilization of Anti-reflux Treatment and Course of Illness Leading to Reoperation After Anti-reflux Surgery in a National Population-based Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03536169
• Other study ID #: JSJ_OP446
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2020
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3717
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease Progression
• Fundoplication
• GERD

Locations

Country	Name	City	State
Denmark	Department of Surgery, Kolding Hospital	Kolding

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern Denmark	Kolding Sygehus, Odense Patient Data Explorative Network

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reoperation	Any reoperative anti-reflux surgery	2000-2017 (Maximum of 17 years follow-up, minimum of 1 year)
Primary	Rate of anti-reflux surgery	Based on Danish census-data	2000-2017
Primary	Rate of pharmacological anti-reflux treatment	Based on Danish census-data	2000-2017
Secondary	Emergency reoperative anti-reflux surgery	Rate of reoperative surgery performed as emergency procedure	2000-2017(Maximum of 17 years follow-up, minimum of 1 year)