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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
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 |
| 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 2010 (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, 10065 | |
| Contact: W. Douglas Wong, MD 212-639-5117 | |
| Study Chair: | W. Douglas Wong, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000298984, MSKCC-02124 |
| Study First Received: | May 6, 2003 |
| Last Updated: | July 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00059891 History of Changes |
| Health Authority: | Unspecified |
|
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 |
|
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms Neoplasms |
Pathologic Processes Neoplasms by Site Digestive System Diseases Postoperative Complications Gastrointestinal Neoplasms Anus Neoplasms Anus Diseases Colorectal Neoplasms |
