Efficacy and Safety of Standard Oral Colonoscopic Preparations With or Without Neostigmine Compared to Pulse-Irrigation Colonic Lavage

July 2, 2014 updated by: US Department of Veterans Affairs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10468
        • VA Medical Center, Bronx

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: SCI MoviPrep® (without NG)
(Spinal Cord Injury (SCI), glomerular filtration rate (GFR)<=50ml/min and SCI, GFR>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid [MoviPrep®] (without neostigmine plus glycopyrrolate [NG])
NO_INTERVENTION: SCI PIEE (without NG)
(Spinal Cord Injury (SCI), glomerular filtration rate (GFR)>=50ml/min) pulsed irrigation enhanced evacuation [PIEE] (without neostigmine plus glycopyrrolate [NG])
NO_INTERVENTION: Control MoviPrep® only
(Control, glomerular filtration rate (GFR)>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid (MoviPrep®) only (no NG)
NO_INTERVENTION: Control PIEE only
(Control, glomerular filtration rate (GFR)>=50ml/min), pulsed irrigation enhanced evacuation (PIEE) only (no NG)
EXPERIMENTAL: SCI MoviPrep® (with NG)
(Spinal Cord Injury (SCI), glomerular filtration rate (GFR)<=50ml/min and SCI GFR>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid [MoviPrep®] (with neostigmine plus glycopyrrolate [NG])
Drug: Neostigmine
Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established
EXPERIMENTAL: SCI PIEE (with NG)
(Spinal Cord Injury (SCI), glomerular filtration rate (GFR)>=50ml/min) pulsed irrigation enhanced evacuation (PIEE) (with neostigmine plus glycopyrrolate [NG])
Drug: Neostigmine
Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Bowel Preparation
Time Frame: 1-2 days following intervention
The quality of bowel preparation was determined by using the Ottawa Scale for bowel Evacuation. The range of this score is from 0 (perfectly clean and dry colon) to 14 ( a colon filled with stool and liquid). The right, mid and rectosigmoid colon were independently rated from 0-4 and fluid quality of entire colon was recorded with an additional score of 0-2. The total Ottawa Score is calculated by the sum of the independent scores of all three sections of the colon plus the fluid content.
1-2 days following intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polyp Detection
Time Frame: Time of Study
The number of polyps detected during colonoscopic procedures were recorded and compared to each bowel cleansing preparation.
Time of Study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

September 2, 2008

First Submitted That Met QC Criteria

September 2, 2008

First Posted (ESTIMATE)

September 3, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 16, 2014

Last Update Submitted That Met QC Criteria

July 2, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6428-R
  • KOR-09-10 (OTHER: James J. Peters VA Medical Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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