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

NCT07343622 | Not Yet Recruiting DMC

• 2 other identifiers: TCA/total colonic aganglionosiNo. MS-2025-406
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Robotic surgery; total colonic aganglionosis; modified Duhamel procedure; modified Soave procedure; Hirschsprung disease

Outcome Measures

Primary Outcomes (2)

• Postoperative bowel function

  Defecation function will be evaluated using the Rintala scoring, which comprises seven domains: bowel control, awareness of the urge to defecate, defecation frequency, stool consistency, fecal soiling, constipation, and social functioning. A total score of 17-20 points is classified as excellent, 12-16 points as good, 9-11 points as fair, and ≤8 points as poor.24 months after definitive pull-through .

  From enrollment to the end of treatment at 24 months

• Hirschsprung-associated enterocolitis (HAEC) incidence

  HAEC diagnosed using a standardized criterion ( prespecified clinical criteria) and recorded as: cumulative incidence, number of episodes, episodes requiring hospitalization/IV antibiotics.

  From enrollment to the end of treatment at 24 months

Secondary Outcomes (8)

• Operative time

  During surgery

• Intraoperative blood loss （ml）

  During surgery

• Postoperative length of stay (days)

  From enrollment to the end of treatment at 24 months

• postoperative complications

  within 30 days and within 12 months

• Number of anal dilatations

  within 6 and 12 months

Study Arms (2)

Transanal Transection Duhamel Pull-Through for total colonic aganglionosis

EXPERIMENTAL

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.

Procedure: Transanal Transection Duhamel operation

Modified Soave Pull-Through for total colonic aganglionosis

ACTIVE COMPARATOR

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.

Procedure: Modified Soave Pull-Through

Interventions

Modified Soave Pull-Through PROCEDURE

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.

Modified Soave Pull-Through for total colonic aganglionosis

Transanal Transection Duhamel operation PROCEDURE

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.

Transanal Transection Duhamel Pull-Through for total colonic aganglionosis

Eligibility Criteria

• Age: 1 Month - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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).

Sponsors & Collaborators

• Zunyi Medical College: lead
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Shenzhen Longhua District Maternity and Child Healthcare Hospital: collaborator
• The Affiliated Hospital of Binzhou Medical College: collaborator
• Guizhou Provincial People's Hospital: collaborator

Study Sites (1)

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563000, China

Location

Related Publications (4)

• Minford JL, Ram A, Turnock RR, Lamont GL, Kenny SE, Rintala RJ, Lloyd DA, Baillie CT. Comparison of functional outcomes of Duhamel and transanal endorectal coloanal anastomosis for Hirschsprung's disease. J Pediatr Surg. 2004 Feb;39(2):161-5; discussion 161-5. doi: 10.1016/j.jpedsurg.2003.10.004.

  PMID: 14966732 BACKGROUND

• Bhandarkar K, De Coppi P, Cross K, Blackburn S, Curry J. Long-Term Functional Outcomes and Multidisciplinary Management after Ileorectal Duhamel Pull-Through for Total Colonic Aganglionosis-20-Year Experience in a Tertiary Surgical Center. Eur J Pediatr Surg. 2024 Oct;34(5):423-429. doi: 10.1055/a-2181-2065. Epub 2023 Sep 25.

  PMID: 37748721 BACKGROUND

• Zhang X, Cao GQ, Tang ST, Chang XP, Li S, Yang L, Li K, Zhou Y, Yang DH. Laparoscopic-assisted Duhamel procedure with ex-anal rectal transection for total colonic aganglionosis. J Pediatr Surg. 2018 Mar;53(3):531-536. doi: 10.1016/j.jpedsurg.2017.06.009. Epub 2017 Jun 27.

  PMID: 28705638 BACKGROUND

• Halaweish I, Srinivas S, Farooqui Z, Sutthatarn P, Campbell D, Frischer J, Wood RJ, Langer JC. Duhamel Versus Swenson Pull-Through for Total Colonic Aganglionosis: A Multi-Institutional Study. J Pediatr Surg. 2024 Feb;59(2):216-219. doi: 10.1016/j.jpedsurg.2023.10.017. Epub 2023 Oct 18.

  PMID: 37973423 BACKGROUND

MeSH Terms

Conditions

Hirschsprung Disease

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Megacolon; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Saotao Tang, M.D

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zebing zheng, M.D

CONTACT

+86-19985120815; zebing1988@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affiliated Hospital of Zunyi Medical University

Study Record Dates

• First Submitted: January 1, 2026
• First Posted: January 15, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)