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

Not Applicable

Completed

• Conditions: Anal Cancer; Colorectal Cancer; Perioperative/Postoperative Complications
• Interventions: Procedure: conventional surgery; Procedure: management of therapy complications

• Registration Number: NCT00059891
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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 Timeline

• Study Start: 2003-01
• Study First Submitted: 2003-05-06
• Study First Submitted QC: 2003-05-06
• Study First Posted: 2003-05-07
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-26
• Last Update Posted: 2013-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anal Sphincter Prosthesis	conventional surgery	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.
Anal Sphincter Prosthesis	management of therapy complications	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.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Determine continence, bowel function, and quality of life of patients treated with this surgery.	2 years

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States