Incisional HerniaNCT05482139
Incisional Hernia Repair With Mesh at Waitemata District Health Board - A 15 Year Retrospective Cohort Study'
An observational study of Incisional Hernia, run by Waitemata District Health Board.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Incisional hernia repair with mesh
- Type of treatment
- Surgery or procedure
- How many people
- 718 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2004to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who had an incisional hernia repair with mesh at WDHB between January 2004 and July 2019
Who may be able to join
- Primary surgical procedure was incisional hernia repair with mesh
Who cannot join
- Suture repair
- Other hernia repair (not incisional)
- Operation notes unavailable
About this study
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.
- Conditions
- Incisional Hernia
- Being tested
- Incisional hernia repair with mesh
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incisional hernia repair with meshProcedure or surgery
open or laparoscopic repairs of incisional hernia with mesh
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative complications
Post operative complications as per Clavien-Dindo classification
Measured: 30-days post procedure
Length of Hospital Stay
How long patients stayed admitted to hospital after surgery
Measured: 0 days - 38 days
Secondary outcomes (1)
Recurrence of hernia
Did patients experience a recurrence of their hernia, if so after what period of time post operatively.
Measured: 0 days - 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Jan 2004
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 718 participants (actual)
Sponsor and investigators
- Lead sponsor
- Waitemata District Health Board
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alina Rankin, Waitemata District Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482139
- Sponsor's protocol ID
- RM14763
- Status last verified
- Jul 2022
- First submitted
- 16 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incisional Hernia Repair With Mesh at Waitemata District Health Board - A 15 Year Retrospective Cohort Study'
- ClinicalTrials.gov ID
- NCT05482139
- Acronym / sponsor ID
- RM14763
- Conditions
- Incisional Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 718 participants (actual)
- Lead sponsor
- Waitemata District Health BoardOther government
- Study start
- 1 Jan 2004 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who had an incisional hernia repair with mesh at WDHB between January 2004 and July 2019
Key inclusion criteria (1 listed)
- Primary surgical procedure was incisional hernia repair with mesh
Key exclusion criteria (3 listed)
- Suture repair
- Other hernia repair (not incisional)
- Operation notes unavailable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incisional hernia repair with meshopen or laparoscopic repairs of incisional hernia with mesh | Procedure or surgery | – |
Primary outcome
Post operative complications
Time frame: 30-days post procedure
Post operative complications as per Clavien-Dindo classification
Length of Hospital Stay
Time frame: 0 days - 38 days
How long patients stayed admitted to hospital after surgery
1 secondary outcome
Recurrence of hernia
Time frame: 0 days - 15 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Incisional Hernia
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
RecruitingObservational study
Patient-Specific Biomechanical Modeling of Incisional Hernias Using Artificial Intelligence and Finite Element Analysis
Incisional Hernia
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Incisional Hernia, run by Waitemata District Health Board.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative complications (time frame: 30-days post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.