Anal Sphincter Prosthesis in Treating Patients Who Are Undergoing Surgery for Anal or Rectal Cancer
This study has been completed.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00059891
First received: May 6, 2003
Last updated: February 26, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Anal Cancer Colorectal Cancer Perioperative/Postoperative Complications |
Procedure: conventional surgery Procedure: management of therapy complications |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Total Anorectal Reconstruction With The American Medical Systems, Inc. Acticon Neosphincter Prosthesis After Abdominoperineal Resection |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Determine continence, bowel function, and quality of life of patients treated with this surgery. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 4 |
| Study Start Date: | January 2003 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Anal Sphincter Prosthesis
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.
|
Procedure: conventional surgery Procedure: management of therapy complications |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00059891
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Study Chair: | W. Douglas Wong, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00059891 History of Changes |
| Other Study ID Numbers: | 02-124, P30CA008748, MSKCC-02124 |
| Study First Received: | May 6, 2003 |
| Last Updated: | February 26, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Anus Neoplasms Rectal Neoplasms Colorectal Neoplasms Postoperative Complications Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Anus Diseases Rectal Diseases Colonic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013