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

July 28, 2022 updated by: Alina Rankin, Waitemata District Health Board
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

718

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Primary surgical procedure was incisional hernia repair with mesh

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Waitemata District Health Board

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2004

Primary Completion (Actual)

July 31, 2019

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

July 16, 2022

First Submitted That Met QC Criteria

July 28, 2022

First Posted (Actual)

August 1, 2022

Study Record Updates

Last Update Posted (Actual)

August 1, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RM14763

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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