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

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Brief Title

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

Official Title

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

Brief 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.
    

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.
    


Study Type

Interventional


Primary Outcome

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.

Secondary Outcome

 Determine continence, bowel function, and quality of life of patients treated with this surgery.

Condition

Anal Cancer

Intervention

conventional surgery

Study Arms / Comparison Groups

 Anal Sphincter Prosthesis
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

4

Start Date

January 2003

Completion Date

October 2009

Primary Completion Date

October 2009

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

W. Douglas Wong, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00059891

Organization ID

02-124

Secondary IDs

P30CA008748

Responsible Party

Sponsor

Study Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

W. Douglas Wong, MD, Study Chair, Memorial Sloan Kettering Cancer Center


Verification Date

February 2013