Anal Sphincter Prosthesis in Treating Patients Who Are Undergoing Surgery for Anal or Rectal Cancer

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.

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