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临床试验/NCT02731391
NCT02731391Unknown不适用

Clinical Research on Bowel Symptoms of Patients With Pelvic Organ Prolapse

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年4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
200
试验地点
1
主要终点
change in the prevalence of bowel symptoms

研究概览

简要总结

To study the prevalence of bowel symptoms in patients with pelvic organ prolapse.

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •The patients with stage>2 POP are recruited.The patients are all received surgeries, which include transvaginal synthetic mesh surgery, the sacral fixation, tissue repair surgery and colpocleisis.

排除标准

  • •Gestation;
  • •Inflammatory bowel disease;
  • •Slow transit constipation diagnosed by Colonic transit test;
  • •Unable to follow up.

研究组 & 干预措施

Mesh repairment

Experimental

patients undergoing pelvic floor Reconstruction using mesh

干预措施: Pelvic floor reconstruction(with or without mesh) (Procedure)

Tradition Neoplasty

Active Comparator

patients undergoing traditional surgical approaches

干预措施: Pelvic floor reconstruction(with or without mesh) (Procedure)

结局指标

主要结局

change in the prevalence of bowel symptoms

时间窗: baseline,1,3,6,12 months after operation.

change in the severity of intestinal symptoms

时间窗: baseline,1,3,6,12 months after operation.

assessed by Birmingham Bowel and Urinary Symptoms Questionnaire

次要结局

  • change in the quality of life(baseline,1,3,6,12 months after operation.)
  • length of the high-pressure zone recorded by anorectal manometry(baseline and 12 months after operation)
  • rectoanal inhibitory reflex recorded by anorectal manometry(baseline and 12 months after operation)
  • Rectal-Vaginal pressure interval during maximum Vasalva(baseline and 6 months after operation)

研究者

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

Tan Cheng

doctor

Peking University People's Hospital

研究点 (1)

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