Clinical trial NCT06874686: Minimally Invasive Surgical Intervention for Hirschsprung's Disease in Pediatric Patients
Official title: Minimally Invasive Laparoscopic Surgery for Hirschsprung's Disease: a Retrospective Study on Patient Safety Profiles, Effectiveness, and Short-term Functional Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hirschsprung Disease
Keywords: Aganglionic
Minimally invasive
Laparoscopic
Pediatric
Single incision
Hirschsprung
Hirschsprung disease
Lead sponsor: National Children's Hospital, Vietnam
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 1050
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes pediatric patients (\<18 years) diagnosed with Hirschsprung's Disease, admitted to National Children's Hospital (2017-2023). Eligible patients exhibited clinical signs and symptoms, with imaging confirming the diagnosis or high clinical suspicion warranting surgery.

All underwent minimally invasive laparoscopic pull-through surgery (CLP or SILS) with documented short-term postoperative outcomes.

Exclusions include patients requiring emergency open laparotomy, those with biopsy findings inconsistent with Hirschsprung's Disease, or incomplete medical records.

Data will be collected retrospectively to assess the safety and effectiveness of these surgical techniques.

Brief 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.

Detailed description: Hirschsprung's disease (HD) is a congenital disorder caused by the absence of enteric ganglion cells in the distal bowel, leading to functional obstruction, delayed meconium passage in neonates, and defecation difficulties. If left untreated, HD can result in life-threatening complications such as Hirschsprung-associated enterocolitis and severe bowel dysfunction. Surgical intervention is necessary to remove the aganglionic segment and restore normal bowel function. In recent years, minimally invasive laparoscopic techniques have gained preference over open surgery due to their potential to reduce intraoperative blood loss, postoperative pain, surgical site infections, and overall hospital stay, while promoting faster recovery and improved cosmetic outcomes. The conventional 3 ports laparoscopic rectal pull-through technique has been widely used as the standard treatment for HD since its introduction in 1995. In 2010, the first case series of single-incision laparoscopic-assisted rectal pull-through (SILS) surgery for HD was reported. The study demonstrated that SILS is safe, yielding comparable surgical outcomes while reducing surgical trauma and enhancing cosmetic results.

Since 2012, the National Children's Hospital has been at the forefront of utilizing minimally invasive approaches for HD treatment in Vietnam, particularly through single-incision laparoscopic surgery (SILS) and conventional multi-port laparoscopic pull-through (CLP). However, despite the increasing adoption of these techniques, there remains a lack of comprehensive data on their surgical outcome, in a lower-middle-income country setting. Factors such as limited research funding, financial constraints preventing patients from accessing long-term follow-up care, and variability in postoperative management contribute to the gap in knowledge regarding these surgical approaches.

This retrospective study aims to systematically evaluate the safety profiles, clinical effectiveness, and short-term functional outcomes of minimally invasive laparoscopic procedures for HD performed at the National Children's Hospital between 2017 and 2023. Key parameters of analysis will include perioperative complications, length of hospital stay, surgical success rates, incidence of postoperative enterocolitis, fecal continence, bowel function recovery, and cost-effectiveness of the intervention. By providing a detailed assessment of these factors, this study seeks to optimize surgical management strategies, enhance postoperative care, and contribute to the growing body of evidence supporting minimally invasive surgical techniques for HD in resource-limited settings.

Eligibility criteria: 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

Primary outcomes:
measure: Volume of Blood Loss
timeFrame: Perioperative
measure: Conversion to open surgery
timeFrame: Perioperative
measure: Operative time
timeFrame: Perioperative
measure: Mortality and severe morbidity
timeFrame: Through study completion, an average of 5 years
measure: Early postoperative complications
timeFrame: Up to 8 weeks post-operation
measure: Time to return of bowel function
timeFrame: Up to 4 weeks post-operation
measure: Rate of reoperation
timeFrame: Through study completion, an average of 5 years
measure: Fecal Continence and Bowel Function Recovery
timeFrame: Through study completion, an average of 5 years
measure: Length of Hospital Stay
timeFrame: Up to 24 weeks post-operation
Secondary outcomes:
measure: Total cost of the Surgical Approach
timeFrame: Through study completion, an average of 5 years
measure: Diagnostic predictive value of X-ray for Hirschsprung Disease
timeFrame: Perioperative
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Department of Surgery, The National Children Hospital, Hanoi
Study officials:
affiliation: Department of Pediatric Surgery, The National Hospital of Pediatrics, Hanoi, Vietnam
name: Quang T Nguyen, M.D.
role: PRINCIPAL_INVESTIGATOR
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