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| Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00059891 |
Purpose
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.
| Condition | Intervention |
|
Anal Cancer Colorectal Cancer Perioperative/Postoperative Complications |
Procedure: conventional surgery Procedure: management of therapy complications |
| MedlinePlus related topics: | Anal Cancer Cancer Colorectal Cancer |
| Study Type: | Interventional |
| Study Design: | Supportive Care |
| Official Title: | Total Anorectal Reconstruction With The American Medical Systems, Inc. Acticon Neosphincter Prosthesis After Abdominoperineal Resection |
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2003 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
PROJECTED ACCRUAL: At least 20 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed distal rectal or anal cancer
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, New York | |||||
| Memorial Sloan-Kettering Cancer Center | Recruiting | ||||
| New York, New York, United States, 10021 | |||||
| Contact: W. Douglas Wong, MD 212-639-5117 | |||||
| Memorial Sloan-Kettering Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | W. Douglas Wong, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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| Study ID Numbers: | CDR0000298984, MSKCC-02124 |
| First Received: | May 6, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00059891 |
| Health Authority: | Unspecified |
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