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:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT06794905
Eligibility Criteria:
Eligibility Criteria
Inclusion Criteria:
* Adults aged 18 years or older.
* Diagnosed with perforated sigmoid diverticulitis classified as Hinchey Stage III or IV.
* Clinically stable patients suitable for emergency colonic resection.
* Eligible to undergo either primary anastomosis with diverting loop ileostomy or Hartmann's procedure.
* Provided informed consent or had a legal surrogate able to consent on their behalf.
Exclusion Criteria:
* Hinchey Stage I or II diverticulitis, typically managed conservatively or with less invasive interventions.
* Postoperative confirmation of malignancy as the primary cause of the perforation.
* Undergoing laparoscopic surgery rather than open resection.
* Clinically unstable patients with severe sepsis, septic shock, or significant hemodynamic compromise.
* Pre-existing stomas or prior colonic resections.
* Significant comorbidities, such as advanced cardiac or respiratory failure.
* Limited life expectancy due to terminal illnesses (e.g., advanced malignancies).
* Inability to participate in follow-up assessments due to cognitive impairments or logistical barriers.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06794905
Study Brief:
Protocol Section:
NCT06794905