What Benefit With a New Stapler Device in the Surgical Treatment of Obstructed Defecation? Two-Year Outcomes From a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- incidence of recurrences
研究概览
简要总结
This randomized study was designed to compare the 2 year clinical and functional results with the STARR procedure using a new curved cutter stapler or the same operation done with 2 traditional circular staplers.
详细描述
From January to November 2006, 80 women were selected, with clinical examination, constipation score, colonoscopy, anorectal manometry, and perineography and randomly assigned to 2 groups: 40 patients underwent stapled transanal rectal resection with two staplers PPH-01 (Ethicon Endosurgery Inc, Pomezia, Italy) (STARR group) and 40 had the same operation with new, curved multi-fire stapler Contour R Transtar TM (TRANSTAR group). Patients were followed up with clinical examination, constipation score, and perineography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rectal prolapse
- •Rectocele
- •ODS score > 15
- •Continence score < 3
- •Resting pressure > 40 mm/Hg
排除标准
- •Previous anorectal surgery
- •Ods score < 15
- •Continence score > 3
- •Resting pressure < 40
- •Concomitant pelvic floor diseases
- •Psychiatric diseases
- •Absolute contraindications to surgery
结局指标
主要结局
incidence of recurrences
时间窗: 2 years
次要结局
- outcomes on symptoms and defecography(2 years)