Robot/Laparoscopic-Assisted Transanal Transection Duhamel Versus Modified Soave Pull-Through for TCA

Official title

Robot/Laparoscopic-Assisted Transanal Transection Duhamel Versus Modified Soave Pull-Through for Total Colonic Hirschsprung Disease: A Multicenter Controlled Trial

Overview

Total colonic Hirschsprung disease (TCA) is the most severe form of Hirschsprung disease and is commonly managed with neonatal enterostomy followed by delayed definitive pull-through. Despite widespread use, the optimal reconstructive procedure for TCA remains uncertain. The Duhamel and modified Soave pull-through procedures are the two most frequently adopted techniques, each with distinct theoretical advantages and limitations regarding bowel function, enterocolitis risk, and anorectal physiology. With the increasing application of minimally invasive and robot-assisted surgery, both procedures have been further refined; however, robust comparative evidence, particularly for total colonic disease, is lacking. To date, no multicenter study has provided a detailed comparison of postoperative functional outcomes and Hirschsprung-associated enterocolitis between transanal transection Duhamel and modified Soave procedures. This multicenter study compares robot-assisted transanal transection Duhamel and modified Soave pull-through in patients with pathologically confirmed TCA after neonatal enterostomy, focusing on postoperative bowel function and enterocolitis incidence.

Detailed description

Total colonic Hirschsprung disease (TCA), also referred to as total colonic aganglionosis, represents the most severe phenotype of Hirschsprung disease and remains a major surgical challenge. Owing to extensive aganglionosis, poor nutritional status, and high risk of enterocolitis in the neonatal period, the current standard of care in most centers consists of neonatal enterostomy followed by a delayed definitive pull-through as a second-stage procedure. Despite advances in minimally invasive techniques, the optimal reconstructive strategy for TCA has not been established.

Among available options, the Duhamel procedure and the modified Soave pull-through are the two most commonly adopted techniques. The Duhamel approach, particularly when combined with a transanal external transection, preserves a retrorectal colonic reservoir, which may reduce anastomotic tension and theoretically improve postoperative bowel function. However, concerns remain regarding fecal stasis, residual spur formation, and the potential risk of postoperative enterocolitis. In contrast, the modified Soave procedure achieves complete endorectal pull-through and eliminates the aganglionic rectal segment, but it may be associated with a higher incidence of anastomotic stricture, cuff-related obstruction, and impaired anorectal motility, especially in patients with extensive disease such as TCA.

With the increasing adoption of robot-assisted and laparoscopic techniques, both procedures have been refined; nevertheless, direct comparative data evaluating functional outcomes, Hirschsprung-associated enterocolitis, and perioperative parameters between transanal transection Duhamel and modified Soave procedures-particularly in total colonic disease-remain scarce. To date, no multicenter study has provided a detailed, standardized comparison of these two surgical strategies in patients with pathologically confirmed TCA.

Therefore, this multicenter study aims to compare robot-assisted transanal transection Duhamel and modified Soave pull-through in patients with total colonic Hirschsprung disease who underwent neonatal enterostomy, with a primary focus on postoperative bowel function and the incidence of Hirschsprung-associated enterocolitis.

Interventions

• Procedure Transanal Transection Duhamel operation
  The modified Duhamel procedure was performed using a transanal external rectal transection technique. Following mobilization of the ganglionated colon, the distal rectum was transected externally through the anal canal, expanding pelvic operative space and improving exposure compared with conventional pelvic transection. A retrorectal channel was created, and the colon was pulled through posterior to the native rectum. Residual rectal septum (spur) was eliminated using a transanal external compr
• Procedure Modified Soave Pull-Through
  The modified Soave procedure was performed as a definitive pull-through following neonatal enterostomy. At approximately 1 year of age or older, patients underwent minimally invasive colectomy using a robotic-assisted or laparoscopic approach. The entire aganglionic colon was resected, and an endorectal pull-through was performed. The terminal ileum was delivered through the rectal cuff and anastomosed to the anal canal to restore intestinal continuity. This technique eliminates the aganglionic

Primary outcome measures

• Postoperative bowel function [Time frame: From enrollment to the end of treatment at 24 months]
• Hirschsprung-associated enterocolitis (HAEC) incidence [Time frame: From enrollment to the end of treatment at 24 months]

Secondary outcome measures (8)

• Operative time [Time frame: During surgery]
• Intraoperative blood loss （ml） [Time frame: During surgery]
• Postoperative length of stay (days) [Time frame: From enrollment to the end of treatment at 24 months]
• postoperative complications [Time frame: within 30 days and within 12 months]
• Number of anal dilatations [Time frame: within 6 and 12 months]
• Anal resting pressure [Time frame: From enrollment to the end of treatment at 24 months]
• Dehydration episodes [Time frame: From enrollment to the end of treatment at 24 months]
• Hospital readmissions [Time frame: From enrollment to the end of treatment at 24 months]

Eligibility criteria

Inclusion criteria

• Definitive diagnosis of total colonic Hirschsprung disease confirmed by pathology from biopsy at neonatal enterostomy, consistent with total colonic aganglionosis.
• Two-stage surgical strategy: neonatal enterostomy performed first, followed by definitive pull-through as a second-stage procedure.
• Planned definitive reconstruction by one of the following techniques:
• Robot-assisted transanal transection Duhamel, orModified Soave pull-through (minimally invasive abdominal phase allowed).
• Availability for follow-up assessments and outcomes collection per protocol.

Exclusion criteria

• Trisomy 21 (Down syndrome).
• Definitive surgery performed by open laparotomy approach or Swenson procedure.
• One-stage primary pull-through without neonatal enterostomy (single-stage definitive management).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Affiliated Hospital of Zunyi Medical University — Zunyi

Publications

• Minford JL, Ram A, Turnock RR, Lamont GL, Kenny SE, Rintala RJ, Lloyd DA, Baillie CT. Comparison of functional outcomes of Duhamel and transanal endorectal coloanal anastomosis for Hirschsprung's disease. J Pediatr Surg. 2004 Feb;39(2):161-5; discussion 161-5. doi: 10.1016/j.jpedsurg.2003.10.004. PMID 14966732
• Bhandarkar K, De Coppi P, Cross K, Blackburn S, Curry J. Long-Term Functional Outcomes and Multidisciplinary Management after Ileorectal Duhamel Pull-Through for Total Colonic Aganglionosis-20-Year Experience in a Tertiary Surgical Center. Eur J Pediatr Surg. 2024 Oct;34(5):423-429. doi: 10.1055/a-2181-2065. Epub 2023 Sep 25. PMID 37748721
• Zhang X, Cao GQ, Tang ST, Chang XP, Li S, Yang L, Li K, Zhou Y, Yang DH. Laparoscopic-assisted Duhamel procedure with ex-anal rectal transection for total colonic aganglionosis. J Pediatr Surg. 2018 Mar;53(3):531-536. doi: 10.1016/j.jpedsurg.2017.06.009. Epub 2017 Jun 27. PMID 28705638
• Halaweish I, Srinivas S, Farooqui Z, Sutthatarn P, Campbell D, Frischer J, Wood RJ, Langer JC. Duhamel Versus Swenson Pull-Through for Total Colonic Aganglionosis: A Multi-Institutional Study. J Pediatr Surg. 2024 Feb;59(2):216-219. doi: 10.1016/j.jpedsurg.2023.10.017. Epub 2023 Oct 18. PMID 37973423

Identifiers

NCT: NCT07343622 · TCA/total colonic aganglionosi · No. MS-2025-406

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗