Clinical trial NCT02129140: Observational Study to Evaluate Ventral Incisional Hernia Repair Using a Biologic Mesh (Cook Biodesign)
Official title: Observational Study to Evaluate Single-Staged Open Complex Ventral Incisional Hernia Repair Using a Biologic Mesh (Cook Biodesign) for Midline Fascial Closure Reinforcement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventral Incisional Hernia
Keywords: hernia repair
ventral incisional hernia
biologic mesh
hernia graft
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2014-05-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study team will screen the office schedules of the investigators for patients presenting for open bowel resection at the Mount Sinai Medical Center. Patients who meet the eligibility criteria will be asked if they are interested in volunteering to participate in the study.

Brief summary: The purpose of this study is to evaluate the efficacy of the Cook Biodesign mesh for the repair of complex ventral incisional hernias. Using materials to reinforce tissue defects is indicated as standard of care for this type of surgery. The Cook Biodesign mesh is currently FDA-approved for implantation to reinforce soft tissues where weakness exists, but the investigators would like to collect additional follow-up information to continue to assess the durability of the repair after placement of the hernia mesh. This follow-up would include the collection of information about complications such as infections and seromas (collections of fluid around the surgery site), as well as hernia recurrence and quality of life questionnaires. Patients who qualify to take part in this study have been diagnosed with a ventral incisional hernia and will have been scheduled for a surgical hernia repair. This surgery will be an "open" surgical procedure and reinforcing your tissue with material is indicated for this type of hernia repair.

Detailed description: Prior to their scheduled surgery, the patient will be consented and will complete a brief quality of life survey. They will also be asked some questions about their medical history that pertain to the study, such as current/ past abdominal infections and surgeries, history of the hernia, comorbidities, etc.

During the surgery, some key data points will be recorded by the research coordinator, such as time of surgery, type of case, size of mesh used, size of the hernia defect, technique used, type of sutures used, etc. The mesh will be placed either retrorectus or intraperitoneally, after the component separation is complete. The mesh will not be used as a "bridge," and the fascial layers will be closed completely.

The research staff may photograph the repair of an enrolled patient's hernia during their treatment and will supply a copy of the photograph to Cook Medical, Inc. if the sponsor's review is requested. Any photograph taken for research purposes will be kept in a password-protected, encrypted database separate from any patient identifying information.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing a ventral incisional hernia repair with mesh
* Age range between 18 and 80 years old

Exclusion Criteria:

* Patients currently enrolled in a clinical trial.
* Patients with a BMI over 40
* Patients in whom the fascial layers cannot be closed or in whom "bridging" would be used
* Patients with a current abdominal abscess or infection
* Patients with healing disorders
* Pregnant women

Primary outcomes:
measure: Hernia Recurrence
timeFrame: up to 2 years
Secondary outcomes:
measure: Infections
timeFrame: up to 2 years
measure: Seromas
timeFrame: up to 2 years
measure: Rehospitalization
timeFrame: up to 2 years
measure: Re-operation
timeFrame: up to 2 years
measure: Mesh Removal
timeFrame: up to 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Joel J Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References: