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

Zunyi Medical College

Status: Not yet enrolling

Conditions: Hirschsprung Disease; Soave; Duhamel; Total Colonic Aganglionosis

Treatments: Procedure: Modified Soave Pull-Through; Procedure: Transanal Transection Duhamel operation

Study type: Interventional

Funder types: Other

Identifiers

NCT07343622

TCA/total colonic aganglionosi

No. MS-2025-406 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 1 month to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Transanal Transection Duhamel Pull-Through for total colonic aganglionosis

Experimental group

Description:

Arm A: Robot-Assisted Transanal Transection Duhamel (Modified Duhamel) Procedure: Robot-assisted or laparoscopic-assisted abdominal mobilization (as per center standard) plus transanal external transection Duhamel pull-through with retrorectal channel creation and side-to-side colorectal/coloanal anastomosis according to a standardized operative protocol. Perioperative care: Standardized bowel preparation (if used), antibiotic prophylaxis, postoperative feeding pathway, and anal dilatation schedule per protocol.

Treatment:

Procedure: Transanal Transection Duhamel operation

Modified Soave Pull-Through for total colonic aganglionosis

Active Comparator group

Description:

Arm B: Modified Soave Pull-Through Procedure: Minimally invasive (laparoscopic or robot-assisted per center capability) mobilization plus modified Soave endorectal pull-through with mucosectomy/cuff management according to a standardized operative protocol. Perioperative care: Same enhanced recovery and dilatation protocol framework.

Treatment:

Procedure: Modified Soave Pull-Through