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:
NCT04612569
Eligibility Criteria:
Inclusion Criteria:
* Low anterior resection of the rectum with mesorectal excision and colorectal anastomosis with or without protective ileostomy
* POLARS score \>20
* over 18 years of age
* give their informed consent
* Patients who can perform a pelvic floor physiotherapy program and to tibial nerve stimulation.
Exclusion Criteria:
* POLARS score less than 20
* LARS-minor or non-LARS
* The existence of residual or distant locoregional disease
* Inflammatory bowel disease (IBD)
* A previous known diagnosis of irritable bowel syndrome (IBS)
* Intestinal resections other than the rectum
* Existence of anastomotic complications
* Inability to perform pelvic muscle physiotherapy, presence of trophic disorders in the ankles (post-febile syndrome)
* Known diabetic neuropathy
* Carriers of pacemakers or implantable defibrillators, and patients who are have previously performed SNS or PTNS.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04612569
Study Brief:
Protocol Section:
NCT04612569