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 @ 12:22 PM
Ignite Modification Date:
2025-12-24 @ 12:22 PM
NCT ID:
NCT01766661
Eligibility Criteria:
Inclusion Criteria:
* Patients with adenocarcinoma of the lower-middle third of the rectum proctoscopy established by rigid proctoscopy, with histological confirmation and candidates of colo-anal anastomosis;
* Patients over 18 years and under 75 years, who can tolerate neoadjuvant and surgical treatment;
* Patients who undergo an ultra-low anterior rectal resection with total mesorectal excision and nerve and sphincter-sparing with curative intention
* Any extension of the primary tumor (T 1-2-3-4) according to the TNM classification;
* Patients with or without lymph node metastasis (N - / +) and with or without resectable distant metastases;
* Patients clinically without fecal incontinence prior to the current illness and with a Wexner incontinence Score less than or equal to 5;
* Patients ASA I, II or III and adequate hematological, renal and hepatic function;
* Patients who signed informed consent.
Exclusion Criteria:
* Altered cognitive state(eg mental retardation or dementia) that prevents collaboration in the study or patients who can neither read nor write
* Fecal incontinence (Wexner equal to or greater than 6);
* Previous surgery or proctological, colonic and anorectal functional disease
* Diagnosis of synchronous colorectal or any other active neoplasm;
* Patients ASA IV, V;
* Pregnancy and lactation;
* Rejection of the patient to sign the consent form.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT01766661
Study Brief:
Protocol Section:
NCT01766661