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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Anal Cancer; Perioperative/Postoperative Complications; Colorectal Cancer

Treatments: Procedure: management of therapy complications; Procedure: conventional surgery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00059891

P30CA008748 (U.S. NIH Grant/Contract)

02-124

MSKCC-02124

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Anal Sphincter Prosthesis

Experimental group

Description:

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.

Treatment:

Procedure: management of therapy complications

Procedure: conventional surgery