Outcomes After Parastomal Hernia Repair

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.

Study Overview

• Status: Completed
• Conditions: Parastomal Hernia
• Intervention / Treatment: Procedure: Complication

Detailed Description

The Danish Hernia Database covers about 80% of all ventral hernia repairs performed in Denmark. Data on size of hernia, type of surgery, type of mesh and fixation method is available from the Danish Hernia Database. All healthcare services in Denmark are registered in the Danish National Patients Registry and data on 30-day readmission rate, readmission diagnosis and reoperation is found here. Each Danish citizen has a unique personal identification number and by merging data from the Danish Hernia Database and National Patients Registry, nationwide data on parastomal hernia repairs is available. The aim of the current study is to evaluate the overall outcomes after parastomal hernia repairs in Denmark from 2007-2017 focusing on readmission and reoperation rates.

• Study Type: Observational
• Enrollment (Actual): 1062

Contacts and Locations

Study Locations

• Denmark
  • Køge, Denmark, 4600
    • Dept. of surgery, Køge Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Parastomal hernia; Patients undergoing parastomal hernia repair in Denmark between 2007 and 2017	Procedure: Complication; Readmission, reoperation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reoperation	Number of patients re-operated for a complication after a parastomal hernia repair	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission	Number of patients readmitted after parastomal hernia repair	90 days
Recurrence	Number of patients operated for recurrence after a parastomal hernia repair	10 years

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Collaborators: Danish Hernia Database
• Investigators: Principal Investigator: Nadia Henriksen, Zealand University Hospital, Koege, Dept. of Surgery

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: January 2, 2019
• First Submitted That Met QC Criteria: January 2, 2019
• First Posted (Actual): January 3, 2019

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: Parastomalhernia 2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No