Incisional Hernia Repair With Mesh at Waitemata District... | NCT05482139

Studies
Incisional Hernia Repair With Mesh at Waitemata District Health Board - A 15 Year Retrospective Cohort Study'

NCT05482139

Sponsor

Waitemata District Health Board

Status

Completed

Last Update Posted

Aug 1, 2022Actual

Enrollment

718Actual

Phase

Not provided

Conditions

Incisional Hernia

Interventions

Incisional hernia repair with mesh

Countries

Not provided

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 2022

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

Jan 1, 2004Actual

Primary Completion Date

Jul 31, 2019Actual

Completion Date

Jul 31, 2019Actual

First Submitted Date

Jul 16, 2022

First Submission Date that Met QC Criteria

Jul 28, 2022

First Posted Date

Aug 1, 2022Actual

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 28, 2022

Last Update Posted Date

Aug 1, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alina Rankin, Non SET Surgical Registrar, Waitemata District Health BoardPrincipal Investigator

Lead Sponsor

Waitemata District Health BoardOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

A retrospective review of all incisional hernia repairs at North Shore Hospital (NSH), Auckland, NZ was performed between January 2004 and July 2019. Patients who had an open or laparoscopic incisional hernia repair with mesh were included in this study. Patients were retrospectively followed up from the date of their operation until the end of the study period.

Detailed Description

Not provided

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

718Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Incisional hernia repair with mesh	Procedure	open or laparoscopic repairs of incisional hernia with mesh

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post operative complications	Post operative complications as per Clavien-Dindo classification	30-days post procedure
Length of Hospital Stay	How long patients stayed admitted to hospital after surgery	0 days - 38 days

Secondary Outcomes

Measure	Description	Time Frame
Recurrence of hernia	Did patients experience a recurrence of their hernia, if so after what period of time post operatively.	0 days - 15 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary surgical procedure was incisional hernia repair with mesh

Exclusion Criteria:

Suture repair
Other hernia repair (not incisional)
Operation notes unavailable

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients who had an incisional hernia repair with mesh at WDHB between January 2004 and July 2019

Sampling Method

Non-Probability Sample

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

Condition Browse Module

MeSH Terms

ID	Term
D000069290	Incisional Hernia

Ancestor Terms

ID	Term
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009074	Melanocyte-Stimulating Hormones

Ancestor Terms

ID	Term
D053486	Melanocortins
D011333	Pro-Opiomelanocortin
D007028	Hypothalamic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided