NCT03792243

Brief Summary

The aim of the current study is to evaluate the overall outcomes after parastomal hernia repairs in Denmark from 2007-2017 using data from the Danish Hernia Database and Danish Patients Registry. Specifically, the readmission and reoperation rates will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,062

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

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

January 2, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 3, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

2.4 years

First QC Date

January 2, 2019

Last Update Submit

July 12, 2023

Conditions

Parastomal Hernia

Outcome Measures

Primary Outcomes (1)

  • Reoperation

    Number of patients re-operated for a complication after a parastomal hernia repair

    30 days

Secondary Outcomes (2)

  • Readmission

    90 days

  • Recurrence

    10 years

Study Arms (1)

Parastomal hernia

Patients undergoing parastomal hernia repair in Denmark between 2007 and 2017

Procedure: Complication

Interventions

ComplicationPROCEDURE

Readmission, reoperation

Parastomal hernia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing parastomal hernia repair in Denmark from 2007-2017

You may qualify if:

  • All patients undergoing parastomal hernia repair in Denmark from 2007-2017

You may not qualify if:

  • If data is not fully registered in the Danish Hernia Database

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of surgery, Køge Hospital

Køge, 4600, Denmark

Location

Study Officials

  • Nadia Henriksen

    Zealand University Hospital, Koege, Dept. of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, DMSc, Ass prof

Study Record Dates

First Submitted

January 2, 2019

First Posted

January 3, 2019

Study Start

May 1, 2020

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

July 14, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)