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 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT04127734
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 years or older;
* Cancer located in the rectum, defined according to the international definition of the rectum consensus \[D'Souza 2019\];
* Rectal cancer resection with primary anastomosis (with or without diverting loop ileostomy) for either primary cancer, completion after local excision or salvage resection for regrowth after watch \& wait or local excision;
* Postoperative anastomotic leakage according to the following definition: "a breach in a surgical join between two hollow viscera, with or without active leak of luminal contents" \[Peel 1991\].
Exclusion Criteria:
* Rectal resection for benign disease;
* Rectal resection for recurrent rectal cancer after previous low anterior resection or other primary malignancies;
* Multivisceral resection (lateral lymph node dissection can be included)
* Emergency resection;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04127734
Study Brief:
Protocol Section:
NCT04127734