Anal Sphincter Prosthesis in Treating Patients Who Are Undergoing Surgery for Anal or Rectal Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anal Cancer; Cancer-Related Problem/Condition; Colorectal Cancer
Intervention: conventional surgery (Procedure); management of therapy complications (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: Memorial Sloan-Kettering Cancer Center Official(s) and/or principal investigator(s):
W. Douglas Wong, MD, Study Chair, Affiliation: Memorial Sloan-Kettering Cancer Center
Summary
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.
Clinical Details
Official title: Total Anorectal Reconstruction With The American Medical Systems, Inc. Acticon Neosphincter Prosthesis After Abdominoperineal Resection
Study design: Supportive Care
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.
PROJECTED ACCRUAL: At least 20 patients will be accrued for this study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States; Recruiting
W. Douglas Wong, MD, Phone: 212-639-5117
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: January 2003
Last updated: October 18, 2008
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