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 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
NCT ID:
NCT03750461
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 18years
2. Patient is undergoing closure of loop ileostomy
3. Patient has a diagnosis of left sided colon or rectal cancer treated with resection and diverting loop ileostomy
4. Patient has been evaluated by a qualified surgeon and found to be a suitable candidate for surgery
Exclusion Criteria:
1. Pre-existing systemic infection at the time of ileostomy takedown
2. Cirrhosis, chronic renal failure requiring dialysis, or collagen disorder
3. On current immunosuppression (anti-tumor necrosis factor (TNF) agents, chemotherapy, or prednisone \>10mg/day)
4. Previous abdominal hernia repair with mesh placement
5. Concurrent procedures in addition to closure of diverting loop ileostomy
6. Ileostomy closure not completed through the previous stoma site (i.e. those requiring exploratory laparotomy for closure)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03750461
Study Brief:
Protocol Section:
NCT03750461