Evaluate and Compare the Rate of Para-Stomal Herniation After Permanent Stoma Formation
Completed · Not applicable
Conditions studied: Hernia
In brief
This study is being done to evaluate the use of a material (Alloderm collagen mesh) during the stomal formation operation (surgery that will create a mouth-like opening on the surface of the body to an internal organ). The main purpose of this research study is to see if using this material will lower the hernia rate compared to normal repair without this material. The secondary purpose is to evaluate if using this material will increase or decrease complication rates.
Key facts
- Study ID
- NCT00577603
- Run by
- Mayo Clinic
- People needed
- 40
- Starts
- 2006-01-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2013-04-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patients will be at least 18 years of age.
- Male or female (excluding pregnant females).
- Patients will require stoma formation.
- Patients with ASA < 3.
- Patients informed about the study, and will have read; understood and signed the patient informed consent and authorization to use their PHI, as applicable.
- Patients will be willing and able to submit to postoperative follow-up evaluations.
You may not qualify if…
- Patients that have had prior surgical treatment parastomal herniation.
- Patients that refuse stoma formation.
- Patients with ASA > 3.
- Patients who have certain metabolic conditions (e.g., chronic hepatic or renal disease).
- Patients with evidence of pre-existing systemic or local infections.
- Patients with wound-healing or autoimmune disorders.
- Patients who, in the surgeon's opinion, would have a difficult time comprehending or complying with the requirements of the study.
- Patients with any conditions that were not suspected preoperatively and are only discovered at the time of the operation.
Where it is running
- Mayo Clinic — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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