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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-14
SponsorZunyi Medical College

About this trial

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.

Eligibility criteria

Qualifiers

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.

Robot-assisted transanal transection Duhamel, orModified Soave pull-through (minimally invasive abdominal phase allowed).

Availability for follow-up assessments and outcomes collection per protocol.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Transanal Transection Duhamel operation
  • Modified Soave Pull-Through

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Zunyi Medical College

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

Shenzhen Maternity & Child Healthcare Hospital

Collaborator

The Affiliated Hospital of Binzhou Medical College

Collaborator

Guizhou Provincial People's Hospital

Collaborator