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



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

For Condition: Anal Cancer,perioperative and postoperative complications,Rectal Cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: An analsphincterprosthesis 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.
Details: 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. PROJECTED ACCRUAL: At least 20 patients will be accrued for this study.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed distal rectal or anal cancer - No recurrent or metastatic disease - Not at high risk for local recurrence - Not a candidate for sphincter-preserving surgery PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - No active pelvic sepsis - Acceptable risk for surgery and general anesthesia - Sufficient dexterity and mental capacity to operate the Acticon Neosphincter prosthesis PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - See Disease Characteristics Other - Not other concurrent investigational products
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
W.Wong,  Study Chair,  Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting W.  Wong 212-639-5117


Additional Information:
Study ID Numbers:
  CDR0000298984;  MSKCC-02124
Study Start Date: 
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059891

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