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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Study of Total Anorectal Reconstruction Using the Acticon Neosphincter Prosthesis After Abdominoperineal Resection in Patients With Anal or Rectal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Supportive care	Active	18 and over	NCI	MSKCC-02124 NCT00059891

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No recurrent or metastatic cancer
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will undergo surgery to remove the rectum and anus and create an ileostomy and perineal colostomy. At least 3 months after surgery, they will undergo placement of the anal sphincter prosthesis around the perineal colostomy. At least 6 weeks later, patients will begin to use the prosthesis. When patients are able to use the prosthesis, they will undergo surgery to close the ileostomy. Quality of life will be assessed and patients will be evaluated at 6 and 12 months and once a year thereafter.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

W. Douglas Wong, MD, Protocol chair		Ph: 212-639-5117; 800-525-2225

U.S.A.
New York
	New York
	Memorial Sloan-Kettering Cancer Center
		W. Douglas Wong, MD	Ph:  212-639-5117 800-525-2225

Registry Information
Official Title		Total Anorectal Reconstruction With The American Medical Systems, Inc. Acticon Neosphincter Prosthesis After Abdominoperineal Resection
Trial Start Date		2003-01-14
Trial Completion Date		2010-01-14 (estimated)
Registered in ClinicalTrials.gov		NCT00059891
Date Submitted to PDQ		2003-03-12
Information Last Verified		2009-07-21
NCI Grant/Contract Number		P30-CA08748

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