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NCT03792243 Clinical Trial

Outcomes After Parastomal Hernia Repair

Parastomal Hernia Clinical Trial

Official title:
Outcomes After Parastomal Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03792243
Other study ID # Parastomalhernia 2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2020
Est. completion date October 1, 2022

Study information
Verified date July 2023
Source Zealand University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1062
Est. completion date October 1, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Complication
Readmission, reoperation

Locations
Country Name City State
Denmark Dept. of surgery, Køge Hospital Køge

Sponsors (2)
Lead Sponsor Collaborator
Zealand University Hospital Danish Hernia Database

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reoperation Number of patients re-operated for a complication after a parastomal hernia repair 30 days
Secondary Readmission Number of patients readmitted after parastomal hernia repair 90 days
Secondary Recurrence Number of patients operated for recurrence after a parastomal hernia repair 10 years
See also
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Completed NCT01380860 - Primary Prevention of Peristomial Hernias Via Parietal Prostheses N/A
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Recruiting NCT04282473 - Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh
Recruiting NCT01955278 - Role of Prosthetic Mesh in Preventing Parastomal Hernias Phase 3
Terminated NCT00641342 - Prevention of Parastomal Hernia by Primary Mesh Insertion Phase 2/Phase 3
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Recruiting NCT03667287 - Stoma Hernia Intraperitoneal Full-Thickness Skin N/A
Completed NCT01722565 - Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia After Laparoscopic Abdominoperineal Resection Phase 4
Completed NCT02368873 - the Use of a IPOM Mesh for Prevention of Parastomal Hernia N/A
Completed NCT00917995 - Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh Phase 2/Phase 3
Completed NCT02233465 - Treating Parastomal Hernia With a Mesh Phase 1/Phase 2
Completed NCT01484743 - Risk Factors for Morbidity After Parastomal Hernia Repair
Completed NCT00509054 - Prevention of Parastomal Hernia With a Mesh Phase 4
Completed NCT04187235 - Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia