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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00059891

Enrollment

Registered

2003-05-07

Start date

2003-01-31

Completion date

2009-10-31

Last updated

2013-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

PROCEDUREconventional surgery

PROCEDUREmanagement of therapy complications

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026