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

NCT06874686 | Completed

• 1 other identifier: 1451_06/BVNTW-VNCSKTE
• Study Type: observational
• Target: 1,050
• Locations: 1 country
• Sites: 1

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.

Conditions

Hirschsprung Disease

Keywords

Aganglionic; Minimally invasive; Laparoscopic; Pediatric; Single incision; Hirschsprung; Hirschsprung disease

Outcome Measures

Primary Outcomes (9)

• Volume of Blood Loss

  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

  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

  Total duration of the surgical procedure from skin incision to closure, measured in minutes.

  Perioperative

• Mortality and severe morbidity

  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

• Early postoperative complications

  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

• Time to return of bowel function

  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

  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

  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

  The total number of days from admission to discharge after surgery, reflecting postoperative recovery and hospital resource utilization.

  Up to 24 weeks post-operation

Secondary Outcomes (2)

• Total cost of the Surgical Approach

  Through study completion, an average of 5 years

• Diagnostic predictive value of X-ray for Hirschsprung Disease

  Perioperative

Study Arms (1)

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

Interventions

Minimally invasive laparoscopic pull-through surgery 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.

MIS-Treated Hirschsprung Patients (2017-2023)

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Children's Hospital, Vietnam: lead

Study Sites (1)

Department of Surgery, The National Children Hospital, Hanoi

Hanoi, Vietnam

Location

Related Publications (12)

• Amiel J, Lyonnet S. Hirschsprung disease, associated syndromes, and genetics: a review. J Med Genet. 2001 Nov;38(11):729-39. doi: 10.1136/jmg.38.11.729.

  PMID: 11694544 BACKGROUND

• Muensterer OJ, Chong A, Hansen EN, Georgeson KE. Single-incision laparoscopic endorectal pull-through (SILEP) for hirschsprung disease. J Gastrointest Surg. 2010 Dec;14(12):1950-4. doi: 10.1007/s11605-010-1299-3. Epub 2010 Aug 18.

  PMID: 20717739 BACKGROUND

• Ure BM, Rintala RJ, Holschneider AM. Scoring postoperative results. Anorectal Malformations Child Embryol Diagnosis, Surg Treat Follow. 2006;351-9. . : . .

  BACKGROUND

• Nguyen LT, Nguyen AT, Nguyen QT, Tran QA, Bui HD, Pham HD. Suspension sutures facilitate single-incision laparoscopic-assisted rectal pull-through for Hirschsprung disease. BMC Surg. 2021 May 31;21(1):274. doi: 10.1186/s12893-021-01260-w.

  PMID: 34059040 BACKGROUND

• Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43.

  PMID: 20596233 BACKGROUND

• Xia X, Li N, Wei J, Zhang W, Yu D, Zhu T, Feng J. Single-incision laparoscopic versus conventional laparoscopic surgery for Hirschsprung's disease: A comparison of medium-term outcomes. J Pediatr Surg. 2016 Mar;51(3):440-3. doi: 10.1016/j.jpedsurg.2015.10.051. Epub 2015 Oct 24.

  PMID: 26611332 BACKGROUND

• Zimmermann P, Martynov I, Perger L, Scholz S, Lacher M. 20 Years of Single-Incision-Pediatric-Endoscopic-Surgery: A Survey on Opinion and Experience Among International Pediatric Endosurgery Group Members. J Laparoendosc Adv Surg Tech A. 2021 Mar;31(3):348-354. doi: 10.1089/lap.2020.0797. Epub 2020 Dec 31.

  PMID: 33395367 BACKGROUND

• Georgeson KE, Robertson DJ. Laparoscopic-assisted approaches for the definitive surgery for Hirschsprung's disease. Semin Pediatr Surg. 2004 Nov;13(4):256-62. doi: 10.1053/j.sempedsurg.2004.10.013.

  PMID: 15660319 BACKGROUND

• Mayo Clinic. Hirschsprung's disease - Symptoms and causes 2021 . : . .

  BACKGROUND

• Puri P, Nakamura H. Epidemiology and Clinical Characteristics of Hirschsprung's Disease. In: Hirschsprung's Disease and Allied Disorders . : . .

  BACKGROUND

• LÊ NH. ĐÁNH GIÁ KẾT QUẢ PHẪU THUẬT BỆNH GIÃN ĐẠI TRỰC TRÀNG BẨM SINH Ở NGƯỜI LỚN TẠI BỆNH VIỆN VIỆT ĐỨC. 2020 . : . .

  BACKGROUND

• Liu, M., Fang, Y., Zhang, B., Lin, Y., Li, O., Bai, J., … & Wu, D. (2020). Laparoscopic-assisted soave operation for the treatment of hirschsprung disease in children: 5 years of experience.. https://doi.org/10.21203/rs.3.rs-18886/v1 . : . .

  BACKGROUND

MeSH Terms

Conditions

Hirschsprung Disease

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Megacolon; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Quang T Nguyen, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 13, 2025
• Study Start: January 1, 2017
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)