Minimally Invasive Surgical Intervention for Hirschsprung Disease

NCT06880666 | Completed

• 1 other identifier: HS50/BB - HĐĐĐ
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Hirschsprung's disease (HD) is one of the most common congenital conditions, with a global incidence of 1/5000 newborns; the prevalence in the Vietnamese population is even higher. The absence of enteric ganglia in the distal bowel causes intestinal obstruction and delayed meconium passage in newborns, as well as failure of normal defecation later in life. If left untreated, HD can lead to life complications such as enterocolitis and even death. Standard treatment involves surgical resection of the affected bowel segment, with minimally invasive laparoscopic techniques offering reduced postoperative complications, shorter hospital stays, and faster recovery compared to open surgery. Since 2012, the National Children Hospital has been the first institution in Vietnam to routinely use the minimally invasive surgical approach for HD. However, due to a lack of research funding and patients' financial constraints to travel to post-operative treatment centers, there has yet to be a publication addressing the long-term outcomes and associated abnormalities of all patients treated with SILS. Thus, the purpose of this study is to report on the safety, efficacy, and long-term functional outcomes and cosmesis results of minimally invasive surgeries performed on HD neonatal patients at The National Children's Hospital from 2020 to 2021, thus optimize surgical management and improve patient outcomes in a lower-middle-income country setting.

Conditions

Hirschsprung Disease

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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. This outcome will be assessed throughout the study period.

  Through study completion, an average of 4 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

• Rintala score

  The Rintala Score assesses postoperative bowel function in pediatric Hirschsprung disease (HD) patients, ranging from 0 to 20. It evaluates stool frequency, incontinence, constipation, and social continence. Scores of 18-20 indicate excellent function with normal bowel habits and no incontinence. Scores of 10-17 suggest moderate function, with occasional issues like constipation or minor incontinence. Scores below 10 reflect poor function, often requiring medical or surgical intervention.

  Through study completion, an average of 4 years

• Manchester Scar Scale

  The Manchester Scar Scale (MSS) evaluates the aesthetic and physical characteristics of scars, scoring from 4 to 28. It assesses scar color, contour, texture, distortion, and patient discomfort. Lower scores (4-8) indicate minimal scarring with good cosmetic outcomes. Moderate scores (9-18) suggest noticeable but acceptable scars with some textural or color irregularities. Higher scores (19-28) reflect severe scarring, often associated with significant discoloration, contour defects, or functional impairment.

  Through study completion, an average of 4 years

Secondary Outcomes (1)

• Associated conditions

  Through study completion, an average of 4 years

Study Arms (1)

MIS-Treated Hirschsprung Patients (2020-2024)

EXPERIMENTAL

Neonatal patients diagnosed with Hirschsprung's Disease, admitted to the National Children's Hospital between 2020 to 2021, and underwent Single incision laparoscopic surgery

Procedure: Minimally invasive laparoscopic pull-through surgery

Interventions

Minimally invasive laparoscopic pull-through surgery PROCEDURE

Conventional laparoscopic pull-through (CLP) surgery utilizes 3-5 small abdominal incisions for the placement of trocars, allowing the insertion of a laparoscopic camera and surgical instruments. After establishing pneumoperitoneum, the aganglionic segment is identified, and the colon is mobilized by dividing the lateral attachments using laparoscopic energy devices. The rectal dissection is performed circumferentially down to the level of the pelvic floor while preserving the mesenteric blood supply. A transanal approach is then used to complete the dissection, pull the mobilized bowel through the anus, and resect the aganglionic segment. A coloanal anastomosis is created, typically with absorbable sutures. Single-incision laparoscopic pull-through (SILS) follows the same principles but is performed through a single umbilical incision using a multi-port device; instruments and a camera are inserted through the same access point.

MIS-Treated Hirschsprung Patients (2020-2024)

Eligibility Criteria

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

You may qualify if:

• Age: From 1 to 28 days old
• Diagnosis: Hirschsprung disease was diagnosed based on clinical presentation, intraoperative frozen section biopsy, and postoperative histopathological findings showing absence of ganglion cells.
• Surgical Approach: Patients underwent SILEP through a single periumbilical incision, with no additional abdominal incisions. All surgeries were conducted by the same team, and postoperative care was provided according to a standardized protocol.
• Parents or guardians provided consent to participate in the study and committed to following the scheduled follow-up visits.

You may not qualify if:

• Patients exhibiting severe HAEC, bowel obstruction, or peritonitis at the time of operation
• Those with a history of failed Hirschsprung disease surgery, prior abdominal operations, or colostomy
• Individuals with contraindications to laparoscopic procedures, such as bleeding disorders or significant congenital heart defects
• Cases where parents or legal guardians refused consent for study participation

Sponsors & Collaborators

• National Children's Hospital, Vietnam: lead

Study Sites (1)

Department of Surgery, The National Children Hospital

Hanoi, Vietnam

Location

Related Publications (12)

• 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

• 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

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

  BACKGROUND

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

  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

• 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

• 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

• 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

• 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

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

  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

• 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

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: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 18, 2025
• Study Start: January 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: March 1, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)