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

Overview

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 Title of Study: “Total Anorectal Reconstruction With The American Medical Systems, Inc. Acticon Neosphincter Prosthesis After Abdominoperineal Resection”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2009

Detailed 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.

Interventions

  • Procedure: conventional surgery
  • Procedure: management of therapy complications

Arms, Groups and Cohorts

  • Experimental: Anal Sphincter Prosthesis
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
    • Time Frame: 2 years

Secondary Measures

  • Determine continence, bowel function, and quality of life of patients treated with this surgery.
    • Time Frame: 2 years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Memorial Sloan Kettering Cancer Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • W. Douglas Wong, MD, Study Chair, Memorial Sloan Kettering Cancer Center

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