Minimally Invasive Surgical Intervention for Hirschsprung's Disease in Pediatric Patients

March 13, 2025 updated by: Nguyen Thanh Quang, National Children's Hospital, Vietnam

Minimally Invasive Laparoscopic Surgery for Hirschsprung's Disease: a Retrospective Study on Patient Safety Profiles, Effectiveness, and Short-term Functional Outcomes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1050

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hanoi, Vietnam
        • Department of Surgery, The National Children Hospital, Hanoi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MIS-Treated Hirschsprung Patients (2017-2023)
Pediatric patients diagnosed with Hirschsprung's Disease, admitted to the National Children's Hospital between January 2017 and December 2023, exhibiting clinical signs and symptoms consistent with Hirschsprung disease, with imaging findings confirming the diagnosis.
Procedure: Minimally invasive laparoscopic pull-through surgery

Pediatric patients diagnosed with Hirschsprung's Disease from 2017-2023 at the National Children's Hospital underwent two minimally invasive procedures: conventional laparoscopic pull-through (CLP) and single-incision laparoscopic pull-through (SILPS).

CLP involves three to five small incisions for trocars, allowing laparoscopic visualization and instrument access. Pneumoperitoneum is established, and the aganglionic colon segment is identified and mobilized using laparoscopic energy devices. The rectum is dissected circumferentially to preserve mesenteric blood supply, and a transanal approach is used to excise the diseased segment, followed by coloanal anastomosis with absorbable sutures.

SILPS follows the same principles but is performed through a single umbilical incision using a multi-port device for all instruments. This technique offers benefits like reduced scarring and less postoperative pain but requires advanced laparoscopic skills due to instrument crowding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of Blood Loss
Time Frame: Perioperative
The amount of blood lost during surgery will be measured in milliliters (mL) by collecting blood from suction devices, counting soaked surgical sponges, and assessing any other visible loss
Perioperative
Conversion to open surgery
Time Frame: Perioperative
The proportion of cases in which single-incision laparoscopic surgery (SILS) could not be optimally completed and required conversion to open surgical techniques. Conversion may be necessitated by factors such as poor visualization, uncontrolled bleeding, adhesions, or patient-specific anatomical challenges. The outcome will be measured as the percentage of procedures requiring conversion during the perioperative period.
Perioperative
Operative time
Time Frame: Perioperative
Total duration of the surgical procedure from skin incision to closure, measured in minutes.
Perioperative
Mortality and severe morbidity
Time Frame: Through study completion, an average of 5 years
The incidence of mortality and severe postoperative complications following single-incision laparoscopic pull-through surgery. Severe morbidity includes life-threatening conditions such as sepsis, multi-organ failure, other major complications requiring intensive medical intervention, and death.
Through study completion, an average of 5 years
Time to return of bowel function
Time Frame: Up to 4 weeks post-operation
The time from surgical intervention to the return of bowel function, defined as the first occurrence of spontaneous bowel movement or passage of flatus without the need for rectal stimulation or enemas
Up to 4 weeks post-operation
Rate of reoperation
Time Frame: Through study completion, an average of 5 years
The proportion of patients who require an additional surgical intervention related to the initial procedure. This includes cases of anastomotic complications, bowel obstruction, stricture formation, or other postoperative issues necessitating reoperation.
Through study completion, an average of 5 years
Fecal Continence and Bowel Function Recovery
Time Frame: Through study completion, an average of 5 years
Frequency of bowel movements, presence of soiling, need for enemas, and ability to maintain voluntary bowel control at follow-up visits.
Through study completion, an average of 5 years
Length of Hospital Stay
Time Frame: Up to 24 weeks post-operation
The total number of days from admission to discharge after surgery, reflecting postoperative recovery and hospital resource utilization.
Up to 24 weeks post-operation
Early postoperative complications
Time Frame: Up to 8 weeks post-operation
The incidence of early postoperative complications, including but not limited to bowel obstruction, surgical site infections, and Hirschsprung-associated enterocolitis (HAEC). Additional complications such as anastomotic leakage, prolonged ileus, or unexpected reoperation will also be monitored.
Up to 8 weeks post-operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total cost of the Surgical Approach
Time Frame: Through study completion, an average of 5 years
Total cost of hospitalization, medications, and additional treatments to assess the overall economic feasibility in a lower-middle-income setting.
Through study completion, an average of 5 years
Diagnostic predictive value of X-ray for Hirschsprung Disease
Time Frame: Perioperative
This outcome measures the diagnostic accuracy of X-ray in detecting Hirschsprung disease by comparing its findings to biopsy results. It evaluates whether the resected bowel contains the aganglionic segment and assesses the completeness of aganglionic bowel resection. Diagnostic performance will be analyzed using sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Perioperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Children's Hospital, Vietnam

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

February 1, 2025

Study Registration Dates

First Submitted

March 2, 2025

First Submitted That Met QC Criteria

March 8, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1451_06/BVNTW-VNCSKTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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