跳至主要内容
临床试验/NCT07468565
NCT07468565尚未招募不适用

A Bicenter Retrospective Comparative Study of the Surgical Approach for the Treatment of Hirschsprung Disease Using the Swenson Technique

University Hospital, Angers0 个研究点目标入组 70 人开始时间: 2026年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
主要终点
To compare the short-term effectiveness of different surgical laparoscopic approaches used for the Swenson technique.

研究概览

简要总结

Hirschsprung disease (HD) is a rare congenital disorder of the enteric nervous system, affecting approximately 1 in 5,000 live births. It is characterized by the absence of ganglion cells in the distal colon, leading to functional intestinal obstruction due to impaired peristalsis. Surgical treatment consists of resection of the aganglionic segment-most commonly rectosigmoid-followed by a colo-rectal, colo-anal, or ileo-anal anastomosis.

Among colo-anal pull-through procedures, the Swenson technique was historically performed through an exclusively transanal approach, which carries a risk of sphincter injury correlated with operative duration. More recently, combined laparoscopic and transanal approaches have been developed to reduce this risk, although they may be associated with higher overall complication and reoperation rates.

The Swenson procedure can be performed using a single-port laparoscopic approach, a technique that is sparsely described in the literature and rarely practiced in France. Single-port laparoscopy represents an emerging surgical technique that, despite increased technical complexity for surgeons, may further enhance postoperative recovery and cosmetic outcomes compared to conventional multiport laparoscopy.

The objective of this study is to describe the outcomes of single-port laparoscopic Swenson pull-through in children with Hirschsprung disease and to compare them with outcomes obtained using more conventional approaches, namely exclusive transanal surgery or combined multiport laparoscopic and transanal approaches.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
— 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children under 16 years of age
  • Diagnosis of Hirschsprung disease confirmed by initial rectal biopsy and postoperative pathological examination
  • Primary Swenson coloanal pull-through performed at Angers or Caen University Hospital between January 1, 2010 and June 30, 2025

排除标准

  • Parental or legal guardian opposition to the use of medical data for research purposes
  • Hirschsprung disease treated with other surgical techniques (Duhamel, Soave, De La Torre, TERPT)
  • Patients operated on in another hospital
  • Patients who underwent rectosigmoid resection for causes of constipation other than Hirschsprung disease

研究组 & 干预措施

SIL-Swenson

Swenson coloanal pullthrough with single incision laparoscopy

干预措施: transanal or laparoscopy assisted Swenson coloanal pullthrough (Procedure)

CL-Swenson

Swenson coloanal pullthrough with conventional (multiport) laparoscopy

干预措施: transanal or laparoscopy assisted Swenson coloanal pullthrough (Procedure)

TA-Swenson

Swenson coloanal pullthrough with exclusive trananal approach

结局指标

主要结局

To compare the short-term effectiveness of different surgical laparoscopic approaches used for the Swenson technique.

时间窗: From surgery to 12 months postoperatively

Short-term effectiveness, defined as spontaneous bowel transit without obstructive-spectrum events during the first postoperative year, including: * Constipation * Delayed resumption of oral feeding * Sphincter hypertonicity * Hirschsprung-associated enterocolitis

次要结局

  • To compare intraoperativensurgical efficiency according to surgical approach(During surgery (day 0))
  • To compare immediate postoperative recovery(At hospital discharge (average 5 days))
  • Short-term complications(From hospital discharge to 30 days after surgery)
  • Long-term complications(From 31 days after surgery up to the last clinical follow-up visit (mean follow-up: 5.5 years))
  • Long-term continence outcomes(Assessed after toilet training age (≥3-4 years old) and up to the last clinical follow-up visit (mean follow-up: 5.5 years))

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

相似试验