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临床试验/NCT07343622
NCT07343622尚未招募不适用

Robot/Laparoscopic-Assisted Transanal Transection Duhamel Versus Modified Soave Pull-Through for Total Colonic Hirschsprung Disease: A Multicenter Controlled Trial

Zunyi Medical College1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Postoperative bowel function

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Month 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

结局指标

主要结局

Postoperative bowel function

时间窗: From enrollment to the end of treatment at 24 months

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 .

Hirschsprung-associated enterocolitis (HAEC) incidence

时间窗: From enrollment to the end of treatment at 24 months

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

次要结局

  • 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)
  • Anal resting pressure(From enrollment to the end of treatment at 24 months)
  • Dehydration episodes(From enrollment to the end of treatment at 24 months)
  • Hospital readmissions(From enrollment to the end of treatment at 24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zebing Zheng

Affiliated Hospital of Zunyi Medical University

Zunyi Medical College

研究点 (1)

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