Minimally Invasive Surgical Intervention for Hirschsprung's Disease in Pediatric Patients (NCT06874686) | Clinical Trial Compass
CompletedNot Applicable
Minimally Invasive Surgical Intervention for Hirschsprung's Disease in Pediatric Patients
Vietnam1,050 participantsStarted 2017-01
Plain-language summary
Hirschsprung's disease (HD) is a congenital disorder characterized by the absence of enteric ganglion cells in the distal bowel, leading to functional obstruction, delayed meconium passage in neonates, and chronic defecation difficulties. Surgical intervention is required to remove the aganglionic segment, with minimally invasive laparoscopic techniques increasingly preferred over open surgery due to reduced postoperative complications, shorter hospital stays, and faster recovery. Since 2012, the National Children's Hospital has pioneered the routine use of single-incision laparoscopic surgery (SILS) for HD in Vietnam. However, there is a lack of comprehensive analysis on the operative outcome in this large group of patients. This retrospective study aims to evaluate patient safety profiles, surgical effectiveness, and functional outcomes of minimally invasive laparoscopic procedures for HD performed at the National Children's Hospital between 2017 and 2023.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All pediatric patients (under 18 years old) diagnosed with Hirschsprung's Disease, admitted to National Children's Hospital between January 2017 and December 2023.
* Patients exhibiting clinical signs and symptoms consistent with Hirschsprung's Disease, with imaging findings confirming the diagnosis. If imaging was inconclusive but clinical suspicion remained high, patients were still considered for surgical evaluation and management.
* Underwent minimally invasive laparoscopic pull-through surgery, either conventional multi-port (CLP) or single-incision (SILS).
* Postoperative Follow-up Data Availability: Patients with documented short-term postoperative outcomes, including bowel function recovery, complications, or reoperation rates.
Exclusion Criteria:
* Clinical instability requiring emergency open laparotomy due to peritonitis, intestinal perforation, or other life-threatening conditions.
* Biopsy findings inconsistent with Hirschsprung's Disease, ruling out the diagnosis.
* Incomplete Medical Records: Patients with missing key data, such as operative details, pathology reports, or follow-up outcomes, that could compromise study integrity
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Volume of Blood Loss
Timeframe: Perioperative
2
Conversion to open surgery
Timeframe: Perioperative
3
Operative time
Timeframe: Perioperative
4
Mortality and severe morbidity
Timeframe: Through study completion, an average of 5 years
5
Early postoperative complications
Timeframe: Up to 8 weeks post-operation
6
Time to return of bowel function
Timeframe: Up to 4 weeks post-operation
7
Rate of reoperation
Timeframe: Through study completion, an average of 5 years