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 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT03909204
Eligibility Criteria:
Inclusion Criteria:
* Refractory (\> 6 months) and severe (based on a =KESS \>11) and non-invasive therapeutic approaches, including an enhanced fiber diet, lifestyle changes, laxatives, and biofeedback failed.
* Slow transit constipation
* Anorectal malformation
* Mixed constipation (combination of outlet obstruction and slow transit)
* Hirschsprung's disease
* Idiopathic constipation ineffective to standard treatment
* Cauda equine syndrome
* Combination of spina bifida and tethered cord
* Colonic neuropathy.
* Persons 18 years or older at the time of signing the informed consent
* Signed informed consent
Exclusion Criteria:
* Non-LAPEC cecostomy procedure
* Pre-existing severe electrolyte imbalance
* Chronic high rectal tone
* Advanced liver cirrhosis (Child B or Child C)
* Pregnancy or puerperium
* Advanced colorectal cancer
* Presence of ventriculoperitoneal shunt
* Colonic disease or surgery that might impact safety of percutaneous colostomy tube placement (right hemicolectomy, IC resection, previous apendicostomy) and confirmed inflammatory bowel disease
* Any other condition, which in the opinion of the investigator would interfere with study requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03909204
Study Brief:
Protocol Section:
NCT03909204