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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT05961969
Eligibility Criteria:
Inclusion Criteria:
* cT1-3 or yT 1-3 rectal adenocarcinoma whose low border was located below the anorectal sling (4 cm from anal verge), in which the required surgery meets the definition of ISR;
* Clinically Tumor-Node-Metastasis (TNM) stage I-III rectal adenocarcinoma;
* Curative and elective surgery;
* American Society of Anesthesiology (ASA) class Ⅰ to Ⅲ patients;
* Age between 20 and 75 years.
Exclusion Criteria:
* cT4 adenocarcinoma, i.e., the rectal cancer invaded to external sphincter or adjacent pelvic organs;
* Evidence of distant metastasis;
* Primary tumor mass≧8 cm in diameter;
* Morbidly obese patients, i.e., body mass index (BMI) ≧ 40 kg/m2 ;
* Previous major surgery of low upper abdomen;
* The adenocarcinoma has invaded to lateral pelvic side wall requiring a lateral pelvic lymph node dissection. (7) Patients with poor anorectal function (Wexner incontinence Score≧ 10)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT05961969
Study Brief:
Protocol Section:
NCT05961969