Feasibility Study of a New Circular Anal Dilator for Transanal Hemorrhoidectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Evaluate the safety of the new device by the number of participants with Adverse Events
研究概览
简要总结
The purpose of this research study is to test the effectiveness of a new anoscope used while performing a traditional hemorrhoidectomy.
详细描述
Historically, surgical hemorrhoidectomy has been effective at eliminating hemorrhoids but is associated with high complication rates and post-operative disability. The problems that are most common immediately after hemorrhoidectomy are severe pain, urinary retention, bleeding and fecal impaction. The most dreaded long term complications are anal stricture and fecal incontinence.
Stricture or narrowing of the anal canal after hemorrhoidectomy is the direct result of excising too much anoderm and mucosa. Even in circumferential prolapsed hemorrhoids, a standard three quadrant hemorrhoidectomy is all that is necessary. Mild anal stricture can be treated with a Hegar dilator but severe stricture requires a lateral internal sphincterotomy with or without a skin advancement flap. These operations are morbid and results are generally poor.
Anal sensation is partially impaired leading to some degree of incontinence of 50% of patients after hemorrhoidectomy. Persistent incontinence results from being over aggressive during the hemorrhoidectomy and excising muscle with the hemorrhoid during dissection.
The majority of these long term complications are solely dependent on surgical technique. The majority of hemorrhoidectomies performed today are still performed by non-specialty surgeons. They rely on various instruments during the surgery to perform the operation in the anal canal with adequate exposure but the most important instrument is the anoscope.
A variety of anoscopes are currently available, but the standard anoscope used for hemorrhoidectomy is the Hill-Ferguson. The Hill-Ferguson is a crescent shaped instrument that provides adequate exposure in the anal canal and allows the surgeon to perform a Ferguson hemorrhoidectomy, the standard of care for hemorrhoidectomy in this country. During this procedure an elliptical excision is begun at the perianal skin to include both external and internal hemorrhoids and is ended at the anorectal ring. A full thickness of mucosa and submucosa is excised and the surgeon should dissect superficial to the internal sphincter muscle. The strip of this excision should be no wider than 1.5 cm but currently nothing prevents the surgeon from exceeding this limitation or from taking muscle with the excision. The widely accepted Hill-Ferguson Anoscopes provide vast exposure but do not set any boundaries for the surgeon when performing this operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with internal or external symptomatic hemorrhoids.
- •Subjects who have failed, or are not suitable for office management of their hemorrhoids.
- •Subjects who are 18 years of age and older
- •Subjects of either gender
- •Subjects, who are willing and able to adhere to protocol requirements, agree to participate in the study program and provide written and informed consent
排除标准
- •Subjects who have had previous hemorrhoid surgery.
- •Subjects with internal hemorrhoids that may be suitable for office management.
- •Subjects with incontinence.
- •Subjects with evidence of acute sepsis or the presence of a fistula.
- •Subjects with a medical condition that may interfere with the evaluation of safety or effectiveness of the study device.
- •Subjects who have another condition that in the opinion of the investigator precludes further participation in the study.
- •Subjects with an anal stricture.
结局指标
主要结局
Evaluate the safety of the new device by the number of participants with Adverse Events
时间窗: 1 year post-operative
This study will be monitored to ensure the identification, documentation and analysis of all adverse events in regards to safety and efficacy of the new device. All adverse events, unforeseen or otherwise will be recorded as data. Information will be reported on the 1)Visual Analog Pain scores, 2)Incontinence score, using the Wexner Oliveira score, 3) Presence of Stenosis 4) Continued bleeding or symptoms, 5) Wound Infection, 6) Bladder Retention
次要结局
- Evaluate the efficacy of the new device by the number of participants with Adverse Events(1 year post operative)
