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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Transanal Transection Duhamel operation
Procedure/SurgeryThe 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.
Modified Soave Pull-Through
Procedure/SurgeryThe 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Transanal Transection Duhamel Pull-Through for total colonic aganglionosisExperimental treatment 1 intervention
Group B: Modified Soave Pull-Through for total colonic aganglionosisActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 .
Time frame
From enrollment to the end of treatment at 24 months2
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.
Time frame
From enrollment to the end of treatment at 24 monthsSecondary outcomes
1
Operative time
During definitive pull-through operation
Time frame
During surgery2
Intraoperative blood loss （ml）
Time frame
During surgery3
Postoperative length of stay (days)
Time frame
From enrollment to the end of treatment at 24 months4
postoperative complications
Overall postoperative complications within 30 days and within 12 months: anastomotic stricture, postoperative bleeding, perianal dermatitis, other prespecified surgical complications (ileus, pelvic abscess, reoperation)
Time frame
within 30 days and within 12 monthsSponsors and contacts
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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
Source ClinicalTrials.gov
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