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Efficacy and Safety of Bowel Preparations for Colonoscopy in SCI


Phase 4
18 Years
N/A
Not Enrolling
Both
Spinal Cord Injury

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Trial Information

Efficacy and Safety of Bowel Preparations for Colonoscopy in SCI


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 polyps is now the central strategy in reducing the risk of colon cancer.
Thus, failure to detect and remove small cancers and polyps can have dire consequences.
Although it has not been shown that persons with spinal cord injury (SCI) have an increased
risk of this disease, there is no reason to assume that the incidence after SCI would be
less than that of the general population.

Colonoscopy would appear to be a better approach to colon cancer screening after SCI but may
also be unreliable if bowel evacuation is unsatisfactory for complete large bowel
visualization. Poor colonoscopic visualization is a major concern in persons with SCI
because they have long-standing difficulty with evacuation (DWE) and might not respond in a
predictable or satisfactory manner to the conventional bowel preparations used for
colonoscopy. Furthermore, to the extent that bowel preparation for colonoscopy is
unsatisfactory in persons with SCI, the putative benefits of colonoscopy in reducing colon
cancer mortality may not be realized.

In the absence of effective regimens for bowel preparation in persons with SCI, we suspect
that the documented benefits of screening colonoscopy in the able-bodied may not generalize
to persons with SCI. Regardless, these observations support the need for improved bowel
preparation approaches in persons with SCI. One such approach might involve the adjunctive
administration of prokinetic drugs to standard practices. A prokinetic agent that might be
beneficial in this context is neostigmine, an anticholinesterase inhibitor with prominent
parasympathomimetic actions (stimulation of peristalsis) on the colon. We have studied
neostigmine extensively in persons with SCI and have shown that, when given in combination
with glycopyrrolate, this approach to stimulate bowel evacuation is safe and effective for
bowel evacuation.


Inclusion Criteria:



1. SCI and able-bodied patients with clinical indication for a colonoscopic examination

Exclusion Criteria:

1. Able-bodied patients with a GFR 50ml/min.

2. SCI and able-bodied patients who are not candidates for elective colonoscopy (i.e.,
those with recent myocardial infarction, terminal illness, etc.)

3. SCI and able-bodied patients who have a contraindication to PEG and/or ascorbic acid
administration (i.e., those with colonic obstruction, etc.)

4. 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)

5. SCI and able-bodied patients with a history of bradyarrhythmia, active coronary
artery disease or asthma will also be excluded from receiving
neostigmine/glycopyrrolate

6. Known hypersensitivity to neostigmine or glycopyrrolate

7. 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.)

8. Lactating/nursing females

9. SCI patients with known adverse reactions to per-rectal colonic lavage.

10. SCI patients with a serum sodium <130 mM.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

Quality of bowel preparation

Outcome Time Frame:

1-2 days following intervention

Safety Issue:

No

Principal Investigator

Mark A. Korsten, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

VA Medical Center, Bronx

Authority:

United States: Federal Government

Study ID:

A6428-R

NCT ID:

NCT00745095

Start Date:

March 2009

Completion Date:

May 2013

Related Keywords:

  • Spinal Cord Injury
  • Safety
  • Efficacy
  • Colonoscopy
  • PIEE
  • MoviPrep
  • Spinal Cord Injuries

Name

Location
VA Medical Center, Bronx Bronx, New York  10468