Observational Study to Evaluate Ventral Incisional Hernia Repair Using a Biologic Mesh (Cook Biodesign)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 2/28/2019 |
| Start Date: | April 2014 |
| End Date: | September 2019 |
Observational Study to Evaluate Single-Staged Open Complex Ventral Incisional Hernia Repair Using a Biologic Mesh (Cook Biodesign) for Midline Fascial Closure Reinforcement
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.
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.
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.
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.
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
We found this trial at
1
site
1428 Madison Ave
New York, New York 10029
New York, New York 10029
(212) 241-6500
Principal Investigator: Joel J Bauer, MD
Phone: 212-241-8033
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
Click here to add this to my saved trials
