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Minimally Invasive Surgical Intervention for Hirschsprung Disease

NCT06880666 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-06-15

No results posted yet for this study

Summary

Hirschsprung's disease (HD) is one of the most common congenital conditions, with a global incidence of 1/5000 newborns; the prevalence in the Vietnamese population is even higher. The absence of enteric ganglia in the distal bowel causes intestinal obstruction and delayed meconium passage in newborns, as well as failure of normal defecation later in life. If left untreated, HD can lead to life complications such as enterocolitis and even death. Standard treatment involves surgical resection of the affected bowel segment, with minimally invasive laparoscopic techniques offering reduced postoperative complications, shorter hospital stays, and faster recovery compared to open surgery. Since 2012, the National Children Hospital has been the first institution in Vietnam to routinely use the minimally invasive surgical approach for HD. However, due to a lack of research funding and patients' financial constraints to travel to post-operative treatment centers, there has yet to be a publication addressing the long-term outcomes and associated abnormalities of all patients treated with SILS. Thus, the purpose of this study is to report on the safety, efficacy, and long-term functional outcomes and cosmesis results of minimally invasive surgeries performed on HD neonatal patients at The National Children's Hospital from 2020 to 2021, thus optimize surgical management and improve patient outcomes in a lower-middle-income country setting.

Conditions

  • Hirschsprung Disease

Interventions

PROCEDURE

Minimally invasive laparoscopic pull-through surgery

Conventional laparoscopic pull-through (CLP) surgery utilizes 3-5 small abdominal incisions for the placement of trocars, allowing the insertion of a laparoscopic camera and surgical instruments. After establishing pneumoperitoneum, the aganglionic segment is identified, and the colon is mobilized by dividing the lateral attachments using laparoscopic energy devices. The rectal dissection is performed circumferentially down to the level of the pelvic floor while preserving the mesenteric blood supply. A transanal approach is then used to complete the dissection, pull the mobilized bowel through the anus, and resect the aganglionic segment. A coloanal anastomosis is created, typically with absorbable sutures. Single-incision laparoscopic pull-through (SILS) follows the same principles but is performed through a single umbilical incision using a multi-port device; instruments and a camera are inserted through the same access point.

Sponsors & Collaborators

  • National Children's Hospital, Vietnam

    lead OTHER

Principal Investigators

  • Quang T Nguyen, M.D. · Department of Pediatric Surgery, The National Hospital of Pediatrics, Hanoi, Vietnam

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2021-12-31
Completion
2025-03-01

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06880666 on ClinicalTrials.gov