NCT01257659终止不适用
STARR Type Trans-anal Resection Versus Vaginal Rectocele Repair Using a Posterier Elevate Prothesis: a Randomized, Multicentric, Prospective Study on Defecatory Function
Centre Hospitalier Universitaire de Nīmes7 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2011年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 7
- 主要终点
- presence/absence of a 50% drop in the ODS score
研究概览
简要总结
The primary objective of this study is to compare the function results between two methods for surgically repairing rectoceles: vaginal versus endo-anal surgery. Our working hypothesis is that the relatively new type of endo-anal surgery will result in better voiding function compared to the traditional vaginal surgery.
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
- •patient is not under any type of guardianship
- •patient has a rectocele > 3 cm during defecography
- •patient has persistent defecatory troubles depite medical treatment (laxatives for at least 1 month) and an ODS score > 10
- •patient recieved information and signed the consent form
排除标准
- •patient cannot read French
- •patient has an asymptomatic rectocele
- •patient with an enterocele at rest upon defecography, with opacification of the small bowel
- •patient with non-rehabilitated anorectal asynchrony (anism)
- •patient with anal incontinence, Wexner score > 7
- •patient has a rectal lesion
- •patient has previously had rectal surgery including a colorectal anastomosis
- •patient has previously had a surgery involving disection of the rectovaginal wall, except for myorraphy of relever muscles
- •patient has previously had pelvic radiotherapy
- •anal sphincter insufficiency detected by rectomanometry
- •megarectum detected by rectomanometry and defecography
- •granule transit anomaly: > 70h
- •exteriorized rectal prolapse
- •rectovaginal fistule
- •intestinal inflammatory disease
- •anal stenosis
- •anal or rectal tumor
- •patient refuses to participate or refuses to sign consent
- •patient is enrolled in another study
- •contra indication for general or localized anesthesia
- •patient does not have social security coverage
结局指标
主要结局
presence/absence of a 50% drop in the ODS score
时间窗: 12 months
presence/absence of a 50% drop in the ODS score: constipation score defined by Altomare et al, 2008.
次要结局
- Questionnaire PFDI 20(36 months)
- presence/absence of prolapse recurrence(36 months)
- Frequency of laxative use(36 months)
- Intervention time (min)(1 day)
- Questionnaire SF 36(36 months)
- Questionnaire PISQ-12(36 months)
- Questionnaire PFIQ 7(36 months)
研究者
研究点 (7)
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