NCT06880666

Minimally Invasive Surgical Intervention for Hirschsprung Disease

Completed NA Last updated 15 June 2025

What this trial tests

NA trial testing Minimally invasive laparoscopic pull-through surgery in Hirschsprung Disease in 23 participants. Completed in 1 March 2025.

Timeline

1 January 2020

Primary endpoint
31 December 2021

1 March 2025

Quick facts

Lead sponsor	National Children's Hospital, Vietnam
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	1 January 2020
Primary completion	31 December 2021
Estimated completion	1 March 2025
Sites	1 location across Vietnam

Drugs / interventions tested

• Minimally invasive laparoscopic pull-through surgery

Conditions studied

• Hirschsprung Disease — all drugs for Hirschsprung Disease →

Sponsor

National Children's Hospital, Vietnam

Who can join

Under 18, any sex, with Hirschsprung Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.