Total Anorectal Reconstruction With The American Medical Systems, Inc. Acticon Neosphincter Prosthesis After Abdominoperineal Resection
18 Years
N/A
Both
Anal Cancer, Colorectal Cancer, Perioperative/Postoperative Complications
Trial Information
Total Anorectal Reconstruction With The American Medical Systems, Inc. Acticon Neosphincter Prosthesis After Abdominoperineal Resection
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.
Subject
Inclusion Criteria:
- Histologically proven cancer of distal rectum or anus
- 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
Subject Exclusion Criteria:
- Patients with recurrent anorectal cancer
- 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
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.
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
W. Douglas Wong, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
02-124
NCT ID:
NCT00059891
Start Date:
January 2003
Completion Date:
October 2009
Related Keywords:
- Anal Cancer
- Colorectal Cancer
- Perioperative/Postoperative Complications
- 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
- Anus Neoplasms
- Rectal Neoplasms
- Colorectal Neoplasms
- Postoperative Complications
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
