NCT04780048

Brief Summary

The purpose of this study is to determine how the patient factors, co-morbid conditions, pre-operative workup, anatomy of the defect, reconstruction details, operative techniques, and type of repairs contribute to the final outcome of abdominal wall reconstruction. The outcomes of interest are: in-hospital complications, discharge disposition, hospital and ICU length of stay, long term follow-up (recurrence, reoperation, and explantation rates).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2017

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2020

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2022

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

5 years

First QC Date

August 13, 2020

Last Update Submit

March 1, 2021

Conditions

Hernia

Keywords

Hernia repair

Outcome Measures

Primary Outcomes (1)

  • In Hospital Complications

    Infection, re-procedures, explantation rates, length of hospital stay and ICU stay.

    3 years

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients aged 18 years and above undergoing Abdominal wall reconstruction with biological mesh irrespective of gender, ethnicity, socio-economic status will be included in the study.

You may qualify if:

  • All patients aged 18 years and above undergoing Abdominal wall reconstruction with biological mesh.

You may not qualify if:

  • Vulnerable patient population (Neonates, Prisoners, Pregnant) will not be included in our study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westchester Medical center

Valhalla, New York, 10595, United States

RECRUITING

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Rifat Latifi, MD

    Chairman Department of Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Agon Kajmolli, MD

CONTACT

9144937936agon.kajmolli@wmchealth.org

Matthew McGuirk, MD

CONTACT

9144937936Matthew.McGuirk@wmchealth.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, General surgery

Study Record Dates

First Submitted

August 13, 2020

First Posted

March 3, 2021

Study Start

July 7, 2017

Primary Completion

July 6, 2022

Study Completion

December 6, 2022

Last Updated

March 3, 2021

Record last verified: 2021-03

Locations

US(1)