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 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT03413904
Eligibility Criteria:
Inclusion Criteria:
* histologically proven solitary mid and low rectal cancer
* proven by rigid rectoscopy, pelvic MRI and digital rectal examination (DRE)
* amenable to curative sphincter-preserving surgery
* no evidence of distant metastases (T3-4a,N0 or T1-4a,N1-2)
* if evaluated after neoadiuvant therapy, no evidence of threaten of the mesorectal fascia (MRF) after therapy
Exclusion Criteria:
* no indication to perform sphincter preservation surgery (Tumors invading into the internal anal sphincter muscle based on pelvic MRI)
* T4b tumor invading adjacent organs
* recurrent cancer
* concurrent or previous diagnosis of invasive cancer within 5 years
* prior history of colorectal resection
* tumors with in growth more than 1/3 of anal sphincter complex or levator ani.
* presence of fecal incontinence at baseline according to Wexner's classification
* emergent surgery with intestinal obstruction or perforation
* absolute contraindications to general anaesthesia or prolonged pneumoperitoneum, such as severe cardiovascular or respiratory disease (ASA class \> III)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03413904
Study Brief:
Protocol Section:
NCT03413904