Outcomes After Parastomal Hernia Repair

Completed

• Conditions: Parastomal Hernia
• Interventions: Procedure: Complication

• Registration Number: NCT03792243
• Lead Sponsor: Zealand University Hospital

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.

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 Timeline

• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2019-01-02
• Study First Posted: 2019-01-03
• Study Start: 2020-05-01
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1062

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parastomal hernia	Complication	Patients undergoing parastomal hernia repair in Denmark between 2007 and 2017

Primary Outcome Measures

Name	Time	Method
Reoperation	30 days	Number of patients re-operated for a complication after a parastomal hernia repair

Secondary Outcome Measures

Name	Time	Method
Readmission	90 days	Number of patients readmitted after parastomal hernia repair
Recurrence	10 years	Number of patients operated for recurrence after a parastomal hernia repair

Trial Locations

Locations (1)

Dept. of surgery, Køge Hospital; 🇩🇰 Køge, Denmark