NCT03536169

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,717

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

August 4, 2020

Status Verified

August 1, 2020

Enrollment Period

2.2 years

First QC Date

May 9, 2018

Last Update Submit

August 2, 2020

Conditions

GERDFundoplication

Outcome Measures

Primary Outcomes (3)

  • Reoperation

    Any reoperative anti-reflux surgery

    2000-2017 (Maximum of 17 years follow-up, minimum of 1 year)

  • Rate of anti-reflux surgery

    Based on Danish census-data

    2000-2017

  • Rate of pharmacological anti-reflux treatment

    Based on Danish census-data

    2000-2017

Secondary Outcomes (1)

  • Emergency reoperative anti-reflux surgery

    2000-2017(Maximum of 17 years follow-up, minimum of 1 year)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Any diagnosis of gastrointestinal cancer during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Kolding Hospital

Kolding, Denmark

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Jonas S Jensen, MD

    Department of Surgery, Kolding Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.d.-student

Study Record Dates

First Submitted

May 9, 2018

First Posted

May 24, 2018

Study Start

June 1, 2018

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

August 4, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Individual patient data are by Danish law no allowed to be shared without specific authorization prior to study initiation.

Locations

DK(1)