Clinical Trial

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

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Summary
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.
Trial Details
NCT Number NCT07343622
Lead Sponsor Zunyi Medical College
Collaborators: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The First Affiliated Hospital of Zhengzhou University, Shenzhen Maternity & Child Healthcare Hospital, The Affiliated Hospital of Binzhou Medical College, Guizhou Provincial People's Hospital
Conditions Total Colonic Aganglionosis, Hirschsprung Disease, Duhamel, Soave
Enrollment 50 participants
Start Date 2026-01-30
Primary Completion 2027-10-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-15