Anal Sphincter Prosthesis in Treating Patients Who Are Undergoing Surgery for Anal or Rectal Cancer
NCT ID: NCT00059891
Last Updated: 2013-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
4 participants
INTERVENTIONAL
2003-01-31
2009-10-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Anal Sphincter Prosthesis
All patients will follow a common treatment algorithm. Anorectal reconstruction with the ABS neosphincter device will be a staged surgical approach. Routine postoperative testing will then be performed at 6 months (+/- 8 weeks) and 12 months (+/- 8 weeks), following ileostomy reversal which we have designated as time zero. Postoperative testing will include completion of a series of questionnaires.
conventional surgery
management of therapy complications
Interventions
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conventional surgery
management of therapy complications
Eligibility Criteria
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Inclusion Criteria
* Not candidates for sphincter preservation
* \> or = 18 years of age
* an acceptable risk for surgery and general anesthesia
* sufficient dexterity and mental capacity to operate the device
* willing and able to give valid Informed Consent
Exclusion Criteria
* Patients with metastatic anorectal cancer
* Patients at high risk for local recurrence
* Patients with active pelvic sepsis
* Patients currently enrolled in another study involving an investigational product
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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W. Douglas Wong, MD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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Other Identifiers
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MSKCC-02124
Identifier Type: -
Identifier Source: secondary_id
02-124
Identifier Type: -
Identifier Source: org_study_id
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