Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04780048 |
| Other study ID # |
L#12086 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 7, 2017 |
| Est. completion date |
December 6, 2022 |
Study information
| Verified date |
March 2021 |
| Source |
New York Medical College |
| Contact |
Agon Kajmolli, MD |
| Phone |
9144937936 |
| Email |
agon.kajmolli[@]wmchealth.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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).
Description:
Background:
Abdominal wall defects are commonly seen in trauma and EGS patients. During the last decade
numerous advances have been made in the management of patients with abdominal wall defects.
These defects are repaired by various surgical techniques including mesh repair (synthetic
vs. biologic), primary repair, etc. However, the outcomes of patients after these injuries
are highly variable and many of these patients suffer from in-hospital complications, mesh
infections requiring explantation, and recurrence. Various factors play a role in the final
outcome of the patient. These include factors associated with the initial surgery or disease
(trauma or emergency general surgery), patient demographics (age, gender, co-morbidities),
preoperative features (hemoglobin and laboratory parameters), technique of repair (onlay,
inlay, retro rectus) and the types of mesh used. However, the role of each of these factors
in the final outcome of patients remains unclear in the literature.
Study Design Study Type: Observational Observational Study Model: Cohort Time Perspective:
Prospective Enrollment: 250 Number of Groups/Cohorts: 1
Recruitment Procedures:
Attending physicians will discuss possible participation in the study with patients who meet
initial screening criteria and have been scheduled for abdominal wall repair/ventral hernia
repair. If a patient agrees, they will be approached by our research coordinator to discuss
consenting. The research coordinator will introduce herself and her role with Westchester
Medical Center, and read the following script. A translator for Spanish speaking patients
will be available.
Hello, my name is _______________. I am a research coordinator with the Department of Surgery
here at Westchester Medical Center. I'm talking to you today because you or your family
member are scheduled to have a surgery that involves abdominal wall repair. Dr. Latifi, the
Director of the Department of Surgery, is conducting a study looking at outcomes from this
surgery. We are interested in how this procedure and personal factors, such as having
diabetes, may contribute to how long you stay in the hospital, have a recurrence or develop
an infection. Participation in this study does not require anything additional from you. You
will receive the same care if you do or do not participate. The only difference is we would
maintain your outcome data for analysis purposes. Would you be interested in learning more
about the study and discussing study details with me and Dr. Latifi? If so, are you able to
meet and when would you like to meet? Or, if you do not know yet, can you provide me with
your phone number or the best way to contact you to schedule a follow-up meeting to discuss
the study?
Research Coordinator meets and collects potential participant contact information.
Meeting will be held to describe study in more detail and to consent participant and/or
representative. If participant is already in the hospital for the procedure, the meeting will
be held as soon as possible.
Data management:
The research involves no more than minimal risk to subjects as it provides no additional
treatment for patients who had abdominal wall defects and are undergoing surgery. Data will
be obtained on their pre and perioperative details, their interventions, and final outcomes.
This study will use a chart review of data from electronic medical records for current
patients. Subjects will be recruited, consented, and medical record data will be gathered
prospectively.
Medical records containing Protective Health Information such as admission and discharge date
will be obtained from the hospital Electronic Medical Record database in the form of a query
spreadsheet to determine hospital and ICU length of stay. All data will be de-identified
using a unique identifier that is assigned to each record.
Data will be queried from the database and kept in a password protected excel spreadsheet.
Only the PI and designated research personnel will have the access to the Protective Health
Information and data linkage file. The PI designated research team members will have the
access to the de-identified data.
Data will be stored and secured in a logbook/secured computer with the PI. Hard copies will
also be stored in closed envelopes in locked cabinets in PI's office. The data will be kept
for a period of seven years and then later will be destroyed. Data will be stored by the
Westchester Medical Center (WMC) Lead PI.
Analytic Plan: Chi-square difference tests will be used to assess significant differences in
predictors on categorical outcomes. T-tests will be used to assess mean differences in
predictors on continuous outcomes. Univariable and multivariable logistic regression analyses
will be conducted for outcomes such as all-cause mortality, pneumonia, sepsis, and
multi-organ failure. Univariable and multivariable linear regression will be performed for
hospital length of stay.
