NCT03052946Unknown2 期
A Prospective Randomized Study Between the Use of Bulking Agent and the Endoanal Electrostimulation Therapy in Patients With Mild or Moderate Anal Incontinence
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 主要终点
- Fecal incontinence
研究概览
简要总结
Randomized trial with a estimated number of 60 patients with mild or moderate anal incontinence at the clinic Physiology of the Hospital das Clínicas of the Medical School of the University of São Paulo (HC-FMUSP).
- Exclusion criteria: symptoms of anal incontinence for less than six months, with severe anal incontinence, associated external anal sphincter damage, past pelvic radiotherapy, evidence of perineal sepsis, rectal prolapse, anorectal cancer, inflammatory bowel disease, malignant disease Congenital formation, scleroderma, Parkinson's disease, immunosuppression and ongoing gestation. In addition, those patients who do not agree to participate in the survey will be excluded.
- The study will have 4 phases: preoperative, surgical, recent postoperative and later postoperative
详细描述
- Prospective randomized trial
- Estimated number of 60 patients with mild or moderate anal incontinence with isolated anal sphincter muscle damage or evidence of anal incontinence without verification of anatomical damage to the anorectal sphincter complex with dysfunction or inadequate action of the internal anal sphincter accompanied at the outpatient clinic Physiology of the Hospital das Clínicas of the Medical School of the University of São Paulo (HC-FMUSP).
- Exclusion criteria: symptoms of anal incontinence for less than six months, with severe anal incontinence, associated external anal sphincter damage, past pelvic radiotherapy, evidence of perineal sepsis, rectal prolapse, anorectal cancer, inflammatory bowel disease, malignant disease Congenital formation, scleroderma, Parkinson's disease, immunosuppression and ongoing gestation. In addition, those patients who do not agree to participate in the survey will be excluded.
- The study will have 4 phases: preoperative, surgical, recent postoperative and later postoperative
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate fecal incontinence
排除标准
- •Severe fecal incontinence
- •Pelvic radiotherapy
研究组 & 干预措施
Bulking agent
Active Comparator
Bulking agent in fecal incontinence
干预措施: Bulking agent (Procedure)
Endoanal electrostimulation
Placebo Comparator
Endoanal electrostimulation in fecal incontinence
干预措施: Endoanal electrostimulation (Procedure)
结局指标
主要结局
Fecal incontinence
时间窗: 6 months
Score of Fecal Incontinence
次要结局
未报告次要终点
研究者
Leonardo Alfonso Bustamante
Surgeon research at the colon and rectum service. Gastroenterology Department
University of Sao Paulo
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