Status:
COMPLETED
Efficacy and Safety of Standard Oral Colonoscopic Preparations With or Without Neostigmine Compared to Pulse-Irrigation Colonic Lavage
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The annual incidence of colorectal cancer in the US during 2005 was approximately 150,000 cases and this neoplasm claimed 56,000 lives (American Cancer Society). Detection (and removal) of colonic pol...
Detailed Description
The annual incidence of colorectal cancer in the US during 2005 was approximately 150,000 cases and this neoplasm claimed 56,000 lives (American Cancer Society). Detection (and removal) of colonic pol...
Eligibility Criteria
Inclusion
- 1\. SCI and able-bodied patients with clinical indication for a colonoscopic examination
Exclusion
- Able-bodied patients with a GFR 50ml/min.
- SCI and able-bodied patients who are not candidates for elective colonoscopy (i.e., those with recent myocardial infarction, terminal illness, etc.)
- SCI and able-bodied patients who have a contraindication to PEG and/or ascorbic acid administration (i.e., those with colonic obstruction, etc.)
- SCI and able-bodied patients who have a contraindication for magnesium citrate (i.e., those with poor renal function, class 2 or greater symptomatic heart failure, ascites)
- SCI and able-bodied patients with a history of bradyarrhythmia, active coronary artery disease or asthma will also be excluded from receiving neostigmine/glycopyrrolate
- Known hypersensitivity to neostigmine or glycopyrrolate
- Potential for pregnancy. Women who are sexually active and of childbearing potential (i.e. not surgically sterile or at least 2 years postmenopausal) must have negative serum pregnancy test.)
- Lactating/nursing females
- SCI patients with known adverse reactions to per-rectal colonic lavage.
- SCI patients with a serum sodium \<130 mM.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00745095
Start Date
March 1 2009
End Date
May 1 2013
Last Update
July 16 2014
Active Locations (1)
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1
VA Medical Center, Bronx
The Bronx, New York, United States, 10468