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 @ 4:30 PM
Ignite Modification Date:
2025-12-24 @ 4:30 PM
NCT ID:
NCT06880666
Eligibility Criteria:
Inclusion Criteria:
* Age: From 1 to 28 days old
* Diagnosis: Hirschsprung disease was diagnosed based on clinical presentation, intraoperative frozen section biopsy, and postoperative histopathological findings showing absence of ganglion cells.
* Surgical Approach: Patients underwent SILEP through a single periumbilical incision, with no additional abdominal incisions. All surgeries were conducted by the same team, and postoperative care was provided according to a standardized protocol.
* Parents or guardians provided consent to participate in the study and committed to following the scheduled follow-up visits.
Exclusion Criteria:
* Patients exhibiting severe HAEC, bowel obstruction, or peritonitis at the time of operation
* Those with a history of failed Hirschsprung disease surgery, prior abdominal operations, or colostomy
* Individuals with contraindications to laparoscopic procedures, such as bleeding disorders or significant congenital heart defects
* Cases where parents or legal guardians refused consent for study participation
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT06880666
Study Brief:
Protocol Section:
NCT06880666