Outcomes After Parastomal Hernia Repair | NCT03792243

Studies
Outcomes After Parastomal Hernia Repair

NCT03792243

Sponsor

Zealand University Hospital

Status

Completed

Last Update Posted

Jul 14, 2023Actual

Enrollment

1,062Actual

Phase

Not provided

Conditions

Parastomal Hernia

Interventions

Complication

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2020Actual

Primary Completion Date

Oct 1, 2022Actual

Completion Date

Oct 1, 2022Actual

First Submitted Date

Jan 2, 2019

First Submission Date that Met QC Criteria

Jan 2, 2019

First Posted Date

Jan 3, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2023

Last Update Posted Date

Jul 14, 2023Actual

Name	Class
Danish Hernia Database	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,062Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parastomal hernia		Patients undergoing parastomal hernia repair in Denmark between 2007 and 2017	Procedure: Complication

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Complication	Procedure	Readmission, reoperation	Parastomal hernia

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nadia Henriksen	Zealand University Hospital, Koege, Dept. of Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of surgery, Køge Hospital		Køge		4600	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided