NCT00059891

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2003

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

February 27, 2013

Status Verified

February 1, 2013

Enrollment Period

6.8 years

First QC Date

May 6, 2003

Last Update Submit

February 26, 2013

Conditions

Anal CancerColorectal CancerPerioperative/Postoperative Complications

Keywords

perioperative/postoperative complicationsstage II anal cancerstage I anal cancerstage III anal cancerstage I rectal cancerstage II rectal cancerstage III rectal cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    2 years

Study Arms (1)

Anal Sphincter Prosthesis

EXPERIMENTAL

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 surgeryProcedure: management of therapy complications

Interventions

conventional surgeryPROCEDURE
Anal Sphincter Prosthesis
management of therapy complicationsPROCEDURE
Anal Sphincter Prosthesis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Anus NeoplasmsColorectal NeoplasmsPostoperative ComplicationsRectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal DiseasesColonic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • W. Douglas Wong, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2003

First Posted

May 7, 2003

Study Start

January 1, 2003

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

February 27, 2013

Record last verified: 2013-02

Locations

US(1)