跳至主要内容
临床试验/NCT05730959
NCT05730959Enrolling By Invitation不适用

Sacral Nerve Modulation in IPAA Patients With Poor Function

University Hospital, Akershus0 个研究点目标入组 22 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
22
主要终点
Øresland Score

研究概览

简要总结

IPAA patients with poor functional outcome where no obvious reason can be detected are identified from our patient registry. These patients are offered a sacral nerve modulation test period of three weeks. They will then be scored on function and physiological testing will be done by a Barostat. After a another 14 days without stimulation the tests will be repeated. Those who respond positively will be offered permanent implantation of the Device..

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • UC With IPAA
  • Bad functional outcome

排除标准

  • Established treatable cause of malfunction

结局指标

主要结局

Øresland Score

时间窗: 12 months

functional score

次要结局

  • Bowel physiology(At inclusion and at 12 months)

研究者

发起方
University Hospital, Akershus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tom Oresland

Clinical professor

University Hospital, Akershus

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