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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00059891
• Other study ID #: 02-124
• Secondary ID: P30CA008748MSKCC
• Status: Completed
• Phase: N/A
• First received: May 6, 2003
• Last updated: February 26, 2013
• Start date: January 2003
• Est. completion date: October 2009

Study information

• Verified date: February 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Colorectal Cancer
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Procedure:
• conventional surgery

• management of therapy complications

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 years	Yes
Secondary	Determine continence, bowel function, and quality of life of patients treated with this surgery.		2 years	No