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临床试验/NCT07410286
NCT07410286已完成不适用

Comparative Study Between Swenson and Soave Techniques for Cases With Hirschsprung Disease

Ahmed Aouf1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年8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
已完成
发起方
入组人数
20
试验地点
1
主要终点
Operative time.

研究概览

简要总结

Hirschsprung's disease is characterized by a lack of enteric nervous system ganglion cells (aganglionosis) in a variable extent of distal bowel. It is the commonest congenital bowel motility disorder and affected neonates usually present with distal intestinal obstruction in the first few days of life. Despite the common underlying pathology of Hirschsprung disease, it has varying presentations. Infants classically present with delayed passage of meconium, feeding intolerance, and bilious emesis. In fact, 90% of children with Hirschsprung will not have passage of stool within the first 24 h of life. Neonates and infants can also present with abdominal distension, failure to thrive, enterocolitis, or bowel perforation.

Hirschsprung's disease is characterized by a variable length of distal colonic aganglionosis. In approximately 80% of cases, it is short-segment, and only involves the rectosigmoid colon. Less commonly, it can extend proximal to the sigmoid colon (15%), include the entire colon (total colonic aganglionosis, 5%), or rarely, the entire intestine (total intestinal aganglionosis). The principles of the operation are to remove the aganglionic colon and connect the normally innervated bowel just above the anus, at a level which prevents further functional obstruction, but at the same time preserves fecal continence.

The surgical treatment of Hirschsprung's disease has evolved from the historical three-stage procedure to a single-stage technique. Since then, multiple series reported its safety, efficacy, and feasibility in the management of HSCR in the neonatal period. Swenson and Bill, Soave, and Duhamel are the most common procedures for Hirschsprung's disease. However, there is a heated debate about which technique gives the best short- and long-term outcomes. There are many surgical approaches to Hirschsprung's disease, including the transabdominal approach (TAB) and transanal endorectal pull-through (TERPT). The TAB includes 4 types: the Swenson, Duhamel, Rehbein, and Soave procedures. Both the Swenson and the Soave procedures have been adapted as transanal approaches.

Transanal access is based on the traditional surgical techniques performed previously in abdominal approach. This type of surgery is used for the treatment of small children. Transanal endorectal pull-through method performed with transanal access is characterized by low invasiveness of surgery and good results of treatment.

The Swenson procedure involves the removal of the entire affected site and end-to-end anastomosis of the normal colonic anal canal. In the Soave procedure, physiological saline is injected into the rectum after cutting through the rectal muscle layer in a circular manner, while keeping the mucosa intact to the dentate line level.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • Pediatric patients who are present with Hirschsprung disease.

排除标准

  • • Patients with severe systemic disease making anesthesia or surgery prohibitively risky (American society of Anesthesiologists (ASA) class IV.
  • Children who underwent secondary surgery from the study.
  • Total colonic aganglionosis.

研究组 & 干预措施

Swenson procedure

Active Comparator

full-thickness dissection is started 1 cm above the dentate line

干预措施: Swenson operation includes resection of the aganglionic segment and anastomosis with full thickness layer above the dentate. (Procedure)

Soave procedure

Active Comparator

circumferential incision is made 1cm above the dentate line in the rectal mucosa. Using blunt dissection, a submucosal plane is developed

干预措施: Soave procedure: includes resection of the aganglionic segment and anastomosis with submucosal thickness layer above the dentate. (Procedure)

结局指标

主要结局

Operative time.

时间窗: From enrollment to the 6 months postoperatively.

Time taken to perform the surgery completely.

次要结局

  • Frequency of defecation(From the time of enrollment to the 6 months after surgery)

研究者

发起方
Ahmed Aouf
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ahmed Aouf

Assistant lecturer

Kafrelsheikh University

研究点 (1)

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