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Total Anorectal Reconstruction With The American Medical Systems, Inc. Acticon Neosphincter Prosthesis After Abdominoperineal Resection


N/A
18 Years
N/A
Not Enrolling
Both
Anal Cancer, Colorectal Cancer, Perioperative/Postoperative Complications

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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 CenterNew York, New York  10021