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

NCT ID: NCT06874686

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1050 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2025-02-28

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.

Conditions

Hirschsprung Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Minimally invasive laparoscopic pull-through surgery

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Children's Hospital, Vietnam

OTHER

Sponsor Role: lead

Responsible Party

Nguyen Thanh Quang

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Quang T Nguyen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatric Surgery, The National Hospital of Pediatrics, Hanoi, Vietnam

Locations

Department of Surgery, The National Children Hospital, Hanoi

Hanoi, , Vietnam

Countries

Vietnam

References

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Other Identifiers

1451_06/BVNTW-VNCSKTE

Identifier Type: -

Identifier Source: org_study_id