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Search / Trial NCT06880666

Minimally Invasive Surgical Intervention for Hirschsprung Disease

Launched by NATIONAL CHILDREN'S HOSPITAL, VIETNAM · Mar 13, 2025

Trial Information

Current as of July 03, 2025

Completed

Keywords

Aganglionic Bowel Minimally Invasive Laparoscopic Single Incision Pediatric Hirschsprung

ClinConnect Summary

Hirschsprung's disease (HD) is one of the most common congenital disorders affecting the gastrointestinal tract, with a global incidence of approximately 1 in 5,000 live births. However, studies suggest that the prevalence is notably higher in the Vietnamese population. The condition arises due to the absence of enteric ganglion cells in the distal colon, leading to a functional obstruction that prevents normal bowel motility. This defect results in delayed meconium passage in newborns, severe constipation, abdominal distension, and feeding intolerance. If left untreated, HD can progress to...

Gender

ALL

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

About National Children's Hospital, Vietnam

National Children's Hospital, Vietnam, is a leading pediatric healthcare institution committed to advancing child health through innovative research and clinical trials. With a focus on improving treatment outcomes and enhancing healthcare delivery for children, the hospital collaborates with international and local partners to conduct rigorous clinical studies across various pediatric specialties. Its multidisciplinary team of healthcare professionals and researchers is dedicated to fostering a safe and ethical environment for clinical research, ensuring the highest standards of care and scientific integrity in all trials. Through its initiatives, National Children's Hospital aims to contribute significantly to the global body of pediatric knowledge and improve health outcomes for children in Vietnam and beyond.

Locations

Hanoi, , Vietnam

Patients applied

0 patients applied

Trial Officials

Quang T Nguyen, M.D.

Principal Investigator

Department of Pediatric Surgery, The National Hospital of Pediatrics, Hanoi, Vietnam

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported