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
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.
- 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
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.
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
Subject Exclusion Criteria:
- 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