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

Memorial Sloan Kettering Cancer Center4 enrolled

Overview

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.

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

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Anal Cancer Colorectal Cancer Perioperative/Postoperative Complications

Interventions

conventional surgeryPROCEDURE

management of therapy complicationsPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

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

Time frame: 2 years

Data from ClinicalTrials.gov

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