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

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Conditions studied: Total Colonic Aganglionosis, Hirschsprung Disease, Duhamel, Soave

In brief

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.

Key facts

Study ID

NCT07343622

Run by

Zunyi Medical College

People needed

50

Starts

2026-01-30

Expected to finish

2027-12-31

Last updated by the study team

2026-01-15

Who can join

Age: 0 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China

Full record on ClinicalTrials.gov

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