Colorectal Cancer Clinical Trial
Official title:
Total Anorectal Reconstruction With The American Medical Systems, Inc. Acticon Neosphincter Prosthesis After Abdominoperineal Resection
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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