Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT00577603
Eligibility Criteria:
Inclusion Criteria:
1. Patients will be at least 18 years of age.
2. Male or female (excluding pregnant females).
3. Patients will require stoma formation.
4. Patients with ASA \< 3.
5. Patients informed about the study, and will have read; understood and signed the patient informed consent and authorization to use their PHI, as applicable.
6. Patients will be willing and able to submit to postoperative follow-up evaluations.
Exclusion Criteria:
1. Patients that have had prior surgical treatment parastomal herniation.
2. Patients that refuse stoma formation.
3. Patients with ASA \> 3.
4. Patients who have certain metabolic conditions (e.g., chronic hepatic or renal disease).
5. Patients with evidence of pre-existing systemic or local infections.
6. Patients with wound-healing or autoimmune disorders.
7. Patients who, in the surgeon's opinion, would have a difficult time comprehending or complying with the requirements of the study.
8. Patients with any conditions that were not suspected preoperatively and are only discovered at the time of the operation.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00577603
Study Brief:
Protocol Section:
NCT00577603