Clinical trial NCT00059891: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anal Cancer
Colorectal Cancer
Perioperative/Postoperative Complications
Keywords: 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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-05-07
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
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.
timeFrame: 2 years
Secondary outcomes:
measure: Determine continence, bowel function, and quality of life of patients treated with this surgery.
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: W. Douglas Wong, MD
role: STUDY_CHAIR
References: