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

February 26, 2013 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: conventional surgery
Procedure: management of therapy complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 2 years
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: W. Douglas Wong, MD, Memorial Sloan Kettering Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

May 6, 2003

First Submitted That Met QC Criteria

May 6, 2003

First Posted (Estimate)

May 7, 2003

Study Record Updates

Last Update Posted (Estimate)

February 27, 2013

Last Update Submitted That Met QC Criteria

February 26, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-124
  • P30CA008748 (U.S. NIH Grant/Contract)
  • MSKCC-02124

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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