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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Total Anorectal Reconstruction With The American Medical Systems, Inc. Acticon Neosphincter Prosthesis After Abdominoperineal Resection

Conditions
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Anal Cancer, Colorectal Cancer, Perioperative/Postoperative Complications

Intervention / Treatment
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* Procedure: conventional surgery
* Procedure: management of therapy complications


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anal Sphincter Prosthesis<br>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. | Procedure: conventional surgery<br> <br> Procedure: management of therapy complications<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine continence, bowel function, and quality of life of patients treated with this surgery. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perioperative/postoperative complications, stage II anal cancer, stage I anal cancer, stage III anal cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer