Total Anorectal Reconstruction With The American Medical Systems, Inc. Acticon Neosphincter Prosthesis After Abdominoperineal Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Determine the risk of complications and feasibility of total anorectal reconstruction using the Acticon Neosphincter prosthesis after abdominoperineal resection in patients with anal or rectal cancer.
研究概览
简要总结
RATIONALE: An anal sphincter prosthesis may replace the need for a permanent colostomy and may improve the quality of life of patients who are undergoing surgery for anal or rectal cancer.
PURPOSE: Clinical trial to study the effectiveness of an anal sphincter prosthesis in treating patients who have anal or rectal cancer and are undergoing surgery to remove the anus and rectum.
详细描述
OBJECTIVES:
- Determine the risk of complications and feasibility of total anorectal reconstruction using the Acticon Neosphincter prosthesis after abdominoperineal resection in patients with anal or rectal cancer.
- Determine continence, bowel function, and quality of life of patients treated with this surgery.
OUTLINE: Patients undergo abdominoperineal resection (APR) with perineal colostomy and diverting loop ileostomy. At least 3 months after APR, patients undergo placement of the Acticon Neosphincter prosthesis. At least 6 weeks after prosthesis placement, the prosthesis is activated. When the patient demonstrates the ability to operate the prosthesis, the ileostomy is reversed.
Quality of life is assessed at 6 and 12 months and then annually thereafter.
Patients are followed at 6 and 12 months and then annually thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject Inclusion Criteria:
- •Histologically proven cancer of distal rectum or anus
- •Not candidates for sphincter preservation
- •> or = 18 years of age
- •an acceptable risk for surgery and general anesthesia
- •sufficient dexterity and mental capacity to operate the device
- •willing and able to give valid Informed Consent
排除标准
- •Patients with recurrent anorectal cancer
- •Patients with metastatic anorectal cancer
- •Patients at high risk for local recurrence
- •Patients with active pelvic sepsis
- •Patients currently enrolled in another study involving an investigational product
研究组 & 干预措施
Anal Sphincter Prosthesis
All patients will follow a common treatment algorithm. Anorectal reconstruction with the ABS neosphincter device will be a staged surgical approach. Routine postoperative testing will then be performed at 6 months (+/- 8 weeks) and 12 months (+/- 8 weeks), following ileostomy reversal which we have designated as time zero. Postoperative testing will include completion of a series of questionnaires.
干预措施: conventional surgery (Procedure)
Anal Sphincter Prosthesis
All patients will follow a common treatment algorithm. Anorectal reconstruction with the ABS neosphincter device will be a staged surgical approach. Routine postoperative testing will then be performed at 6 months (+/- 8 weeks) and 12 months (+/- 8 weeks), following ileostomy reversal which we have designated as time zero. Postoperative testing will include completion of a series of questionnaires.
干预措施: management of therapy complications (Procedure)
结局指标
主要结局
Determine the risk of complications and feasibility of total anorectal reconstruction using the Acticon Neosphincter prosthesis after abdominoperineal resection in patients with anal or rectal cancer.
时间窗: 2 years
次要结局
- Determine continence, bowel function, and quality of life of patients treated with this surgery.(2 years)