Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059891
Status:
COMPLETED
Last Update Posted:
2013-02-27
First Post:
2003-05-06
Brief Title:
Anal Sphincter Prosthesis in Treating Patients Who Are Undergoing Surgery for Anal or Rectal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Total Anorectal Reconstruction With The American Medical Systems Inc Acticon Neosphincter Prosthesis After Abdominoperineal Resection
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-02124 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |