NCT00556283已完成4 期
Outcomes of Stapled Trans-Anal Rectal Resection (STARR) vs. Biofeedback in the Treatment of Outlet Obstruction Associated With Rectal Intussusception and Rectocele: A Multi-center Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 18
- 主要终点
- ODS total score
研究概览
简要总结
This study aimed to evaluate the safety and symptomatic outcomes achieved with Stapled Transanal Rectal Resection (STARR) compared to biofeedback training in patients with obstructed defecation syndrome (ODS).
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
- 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
- •Female patients >18 years old
- •Able to comprehend, follow, and provide written informed consent.
- •Minimum ODS Score of seven at screening.
- •Negative pregnancy test, by urine.
- •'Obstructed' defecation requiring straining/digitation as presenting lead symptom.
- •Adequate external sphincter on rectal digital examination.
- •Evidence of anterior rectocele and/or rectal intussusception on dynamic defecography. (Note: dynamic defecography taken within 12 months will be acceptable)
- •Willingness to comply with study requirements including follow-up visits
排除标准
- •Evidence of external sphincter injury associated with incontinence.
- •Enterocele at rest- requiring surgery.
- •Faecal incontinence (soiling and faecal urgency is admissible).
- •Any anterior defect, colpocele or cystocele requiring a combined surgical approach.
- •Physical or psychological condition which would impair participation in the study.
- •Participation in any other device or drug study within 90 days prior to enrollment.
- •Planned participation in any other device study during the timeframe of this study.
- •General contraindication for surgery.
- •Previous transanal surgery for ODS.
- •Immunocompromised subjects
研究组 & 干预措施
2
Active Comparator
Biofeedback
干预措施: Biofeedback (Behavioral)
1
Experimental
STARR
干预措施: STARR (Device)
结局指标
主要结局
ODS total score
时间窗: 12 months
次要结局
- PAC-QoL score(12 months)
研究者
研究点 (18)
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