跳至主要内容
临床试验/NCT03269812
NCT03269812Unknown不适用

Laparoscopic Assisted Pull-through Versus Other Surgical Procedures for Treatment of Hirschsprung Disease.

Assiut University0 个研究点目标入组 60 人开始时间: 2017年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
主要终点
Constipation

研究概览

简要总结

To evaluate the outcomes of laparoscopic pull-through concerning constipation, incontinence and enterocolitis in comparison of other surgical procedures for treatment of Hirschsprung disease.

详细描述

Hirschsprung,s disease (HD) is a relatively common cause of intestinal obstruction in the newborn[1,2], The main goal in the treatment of patients with Hirschsprung,s disease is to resect the aganglionic segment and pull down the Normo-ganglionic bowel[3]. With the introduction of minimally invasive surgery, classic pull-through techniques were modified and improved with laparoscopy, because of the obvious advantages of laparoscopic-assisted pull-through operations in form of reduced pain and improved cosmoses this approach has gained much popularity[4,5].

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
6 Months 至 36 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Age from 6months to 3 years.
  • •Both sexes.
  • •Classic and long segment Hirshsprung.
  • •Total a ganglionic colon.
  • •Hirshsprung disease with leveling colostomy

排除标准

  • •Patients <6 months and >3 years.
  • •Short and Ultra-short Hirshsprung.
  • •Recurrent cases of Hirshsprung.
  • •Other contraindication of laparoscopy

研究组 & 干预措施

laparoscopic operated group

Experimental

Under general anesthesia and insertion of ports for laparoscopic instruments, laparoscopic assisted mobilization of sigmoid colon and dissection till pelvis and removal of a ganglionic segment of colon and laparoscopic assisted pull through of colon then colo-anal anastomosis will be done,

干预措施: laparoscopic assisted pull-through oeration (Procedure)

non laparoscopic operated group

Experimental

Under general anesthesia ,abdominal exploration ,removal of a ganglionic part by soav ,duhamel procedures and trans-anal pull through procedures.

干预措施: laparoscopic assisted pull-through oeration (Procedure)

结局指标

主要结局

Constipation

时间窗: from one to three months after operation

persistace of inablilty to pass stool even after operation and treatment,it is physiological parameter and assisted by asking the mothers of patients about the bowel habits.

次要结局

未报告次要终点

研究者

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

Mohammed Hamada Takrouney

Principal investigator and Assistant lecturer of pediatric surgery

Assiut University

相似试验