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

NCT07343622 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-15

No results posted yet for this study

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.

Conditions

  • Total Colonic Aganglionosis
  • Hirschsprung Disease
  • Duhamel
  • Soave

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 compression technique, enabling a wide side-to-side colorectal or coloanal anastomosis. The anterior rectal wall was preserved, maintaining rectal sensory structures and avoiding circumferential endorectal dissection as used in Soave procedures. This approach was intended to optimize anastomotic configuration and postoperative bowel function.

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 colorectal segment and avoids creation of a retrorectal pouch. Perioperative management and postoperative care were standardized across participating centers according to the study protocol.

Sponsors & Collaborators

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

    collaborator OTHER
  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER
  • Shenzhen Longhua District Maternity and Child Healthcare Hospital

    collaborator UNKNOWN
  • The Affiliated Hospital of Binzhou Medical College

    collaborator UNKNOWN
  • Guizhou Provincial People's Hospital

    collaborator OTHER
  • Zunyi Medical College

    lead OTHER

Principal Investigators

  • Saotao Tang, M.D · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-30
Primary Completion
2027-10-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07343622 on ClinicalTrials.gov