Long Term Outcomes Following Hernia Repair With Mesh | NCT04578340

Studies
Long Term Outcomes Following Hernia Repair With Mesh

NCT04578340

Sponsor

Endeavor Health

Status

Recruiting

Last Update Posted

Nov 14, 2023Actual

Enrollment

4,700Estimated

Phase

Not provided

Conditions

Abdominal Hernia

Interventions

Not provided

Countries

United States

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

Nov 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Oct 1, 2025Estimated

Completion Date

Oct 1, 2026Estimated

First Submitted Date

Oct 1, 2020

First Submission Date that Met QC Criteria

Oct 1, 2020

First Posted Date

Oct 8, 2020Actual

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

Nov 11, 2023

Last Update Posted Date

Nov 14, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michael Ujiki MD, Director of Minimally Invasive Surgery; Chief, Division of Gastrointestinal and General Surgery, Endeavor HealthPrincipal Investigator

Lead Sponsor

Endeavor HealthOTHER

Collaborators

Name	Class
Medtronic	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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 objective of this study is to establish the extent to which mesh improves quality of life and surgical outcomes following hernia repair.

Detailed Description

This is a large scale registry of prospectively collected medical record data and self-reported outcomes for those patients undergoing abdominal hernia repair with mesh.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,700Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hernia recurrence rate	Should the hernia repair fail and the hernia reappears, this is counted as a recurrent hernia.	Within 5 years of initial hernia repair
Patient quality of life	Quality of life before and after surgery will be compared using various self-reported assessment tools/questionnaires.	Up to 5 years postopertively

Secondary Outcomes

Measure	Description	Time Frame
Postoperative infection rate	Infection related to hernia repair or mesh use will be reported.	Up to 5 years postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

abdominal hernia repair using mesh

Exclusion Criteria:

less than 18 years old

Accepts Healthy Volunteers

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

Multihospital system inclusive of all abdominal hernia repairs using mesh

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NorthShore University HealthSystem	Recruiting	Evanston	Illinois	60201	United States

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
D046449	Hernia, Abdominal

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided