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临床试验/NCT02147574
NCT02147574已完成4 期

Laparoscope Subtotal Colectomy With Anti-peristaltic Ileo-sigmoid Anastomosis for the Treatment of Slow-transit Constipation:Therapeutic Evaluation

Anlong Zhu1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年12月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Improvement of signs and symptoms associated with constipation complication

研究概览

简要总结

Purpose:

To evaluate the curative effect of Laparoscope Sub-total Colectomy with Anti-peristaltic ileosigmoid anastomosis for the treatment of slow-transit constipation on the patients with STC.

Methods and techniques:

The data of patients with STC preformed surgery of laparoscopic subtotal colectomy with anti-peristaltic ileosigmoid anastomosis during 2009.01-2014.05 was reviewed. The related status such as frequency of defecation, course of constipation, laxatives use condition the condition of using laxatives, and changes in weight were investigated. Changes of defecation and weight, periprocedural complications (wound infection, lung infection and intestinal fistula), long-term complication (malnutrition, abdominal pain, ileus), life satisfaction, wexner score of pre-operation and postoperation ect were investigated in follow-ups.

详细描述

Theoretical Basis:

As far as the current research status, total colectomy or subtotal colectomy has become the preferred type of surgery for slow-transit constipation treatment. There are different opinions on intestinal anastomosis and the specific scope of excision. There is a type of surgery reserving the ileocecum, as the ileocaecal valve has the function of postponing the fecal evacuation. There's also a type of surgery excising the ileocecum , and establishing the pouch, as reserving the ileocecum may cause the recurrence of constipation, and establishing the pouch has function of relieving the postoperative fecal incontinence. On the basis, our own type of surgery is designed; ileocecum is excised for preventing the recurrence of constipation, while the anti-peristaltic ileosigmoid anastomosis between the small intestine and part of sigmoid is made for preventing the severe diarrhea.

Methods and techniques:

The data of patients with STC preformed surgery of laparoscopic subtotal colectomy with anti-peristaltic ileosigmoid anastomosis during 2009.01-2014.05 was reviewed. The related status such as frequency of defecation, course of constipation, laxatives use condition the condition of using laxatives, and changes in weight were investigated. Changes of defecation and weight, periprocedural complications (wound infection, lung infection and intestinal fistula), long-term complication (malnutrition, abdominal pain, ileus), life satisfaction, wexner score of pre-operation and postoperation ect were investigated in follow-ups.

Surgical operation process:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • the clinical diagnose of STC
  • Severe symptoms of constipation, defecating less than 2 times per week, no awareness of defecation, using laxatives to help defecation or there's no effects of laxatives.
  • Symptoms of constipation last at least 2 years, and ineffective effects received from medicine treatment for more than one year.
  • Colorectal organic disease was excluded
  • More than one colonic transit trials suggest dysfunction of colon transport, no significant intestinal transit dysfunction

排除标准

  • significant mental disorder
  • surgical contraindications
  • Can't accept surgery subjectively

结局指标

主要结局

Improvement of signs and symptoms associated with constipation complication

时间窗: preoperative, and at 6 months postoperative

次要结局

  • Improvement of signs and symptoms associated with constipation complication(preoperative, at 12 months postoperative)

研究者

发起方
Anlong Zhu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anlong Zhu

Vice Chairman

First Affiliated Hospital of Harbin Medical University

研究点 (1)

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