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 @ 7:30 PM
Ignite Modification Date:
2025-12-24 @ 7:30 PM
NCT ID:
NCT06474403
Eligibility Criteria:
Inclusion Criteria:
1. Adult patients with a confirmed diagnosis of parastomal hernia post-stoma creation surgery;
2. Symptomatic hernias requiring surgical intervention;
3. Able to undergo the surgical approach under general anesthesia;
4. Patients who can provide informed consent.
Non-Inclusion Criteria:
Patients with contraindications to laparoscopic surgery, such as uncontrolled coagulopathies, severe cardiorespiratory conditions, or extensive intra-abdominal adhesions are excluded. Those with ongoing peritonitis, incarcerated hernias requiring urgent care, or malignancy at the hernia site are also excluded.
Exclusion Criteria:
* Patients unwilling to provide informed consent;
* Patients with a life expectancy less than the study follow-up period;
* Patients who have previously undergone other types of hernia repair, which could confound the operative and postoperative outcomes being measured.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06474403
Study Brief:
Protocol Section:
NCT06474403