Use of High Resolution Colonic Manometry in Studying Motility
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | October 2015 |
| End Date: | December 2017 |
| Contact: | Mark A Korsten, MD |
| Email: | mark.korsten@va.gov |
| Phone: | 718-584-9000 |
Safety and Efficacy of High Resolution Manometry in Studying Colonic Motility and Iontophoretic Administration of Prokinetic Agents
An injury to the spinal cord (SCI) results in numerous medical complications, including
gastrointestinal (GI) function. Individuals with SCI may experience severe constipation
(prolonged stool retention), incontinence (accidents), and overall difficulty in bowel
evacuation. While various treatments and medications have been established to address this
complication, there is little knowledge relating to the overall colonic motility. However,
new technology such as High Resolution Colonic Manometry allows physicians to visualize high
pressure contractions inside the colon, leading to a greater understanding of typical
motility, a more accurate diagnosis, and an effective treatment. In this study, the
investigators propose to use this technology to understand the effects of SCI on colonic
motility by comparing to normal colonic function observed in able-bodied (AB) individuals.
In addition, the investigators plan to study the effects of pharmacological treatments, such
as neostigmine, on promoting peristaltic contractions in the colon as it is delivered across
the skin.
gastrointestinal (GI) function. Individuals with SCI may experience severe constipation
(prolonged stool retention), incontinence (accidents), and overall difficulty in bowel
evacuation. While various treatments and medications have been established to address this
complication, there is little knowledge relating to the overall colonic motility. However,
new technology such as High Resolution Colonic Manometry allows physicians to visualize high
pressure contractions inside the colon, leading to a greater understanding of typical
motility, a more accurate diagnosis, and an effective treatment. In this study, the
investigators propose to use this technology to understand the effects of SCI on colonic
motility by comparing to normal colonic function observed in able-bodied (AB) individuals.
In addition, the investigators plan to study the effects of pharmacological treatments, such
as neostigmine, on promoting peristaltic contractions in the colon as it is delivered across
the skin.
The investigators data suggests that the fundamental consequence of SCI is a slowing of
intestinal peristaltic activity, most likely as a result of down regulation of
parasympathetic neural pathways. Furthermore, the investigators have effectively shown that
measures involved in increase parasympathetic stimulation results in efficient bowel
evacuation and improved bowel care. Such measures include the administration of neostigmine
(NEO), which increases peristaltic contractions in the colon, resulting in predictable bowel
evacuations. Given the cardiopulmonary side-effects of NEO, an ant-cholinergic known as
Glycopyrrolate (GLY) is usually co-administered with NEO to reverse these side effects.
However, the investigators knowledge regarding the effects of SCI on colonic motility is
still primitive, mainly due to pervious technological disadvantages. New High Resolution
Colonic Manometry systems (Medical Measurement Systems Dover, NH) simultaneously capture
high amplitude pressure contractions (HAPCs) across the ascending, transverse, descending,
and recto-sigmoid colon. Such capabilities allow for a much clearer display of pressure
events compared to previous line tracing manometric systems and the direction of
contractions are much easier to discern as well. To date, this technology has been an
effective tool in diagnosing bowel disorders and complications, such as constipation in
able-bodied individuals (AB). However, such studies have not been conducted in a SCI
population. This technology also has the potential to capture the effects of NEO+GLY on
improving colonic function.
intestinal peristaltic activity, most likely as a result of down regulation of
parasympathetic neural pathways. Furthermore, the investigators have effectively shown that
measures involved in increase parasympathetic stimulation results in efficient bowel
evacuation and improved bowel care. Such measures include the administration of neostigmine
(NEO), which increases peristaltic contractions in the colon, resulting in predictable bowel
evacuations. Given the cardiopulmonary side-effects of NEO, an ant-cholinergic known as
Glycopyrrolate (GLY) is usually co-administered with NEO to reverse these side effects.
However, the investigators knowledge regarding the effects of SCI on colonic motility is
still primitive, mainly due to pervious technological disadvantages. New High Resolution
Colonic Manometry systems (Medical Measurement Systems Dover, NH) simultaneously capture
high amplitude pressure contractions (HAPCs) across the ascending, transverse, descending,
and recto-sigmoid colon. Such capabilities allow for a much clearer display of pressure
events compared to previous line tracing manometric systems and the direction of
contractions are much easier to discern as well. To date, this technology has been an
effective tool in diagnosing bowel disorders and complications, such as constipation in
able-bodied individuals (AB). However, such studies have not been conducted in a SCI
population. This technology also has the potential to capture the effects of NEO+GLY on
improving colonic function.
Inclusion Criteria:
- Chronic SCI >1year
- Able-Bodied (non SCI)
- Undergoing Elective Colonoscopy
- Age 18-75 years.
Exclusion Criteria:
- Previous adverse reaction or hypersensitivity to electrical stimulation
- Known sensitivity to neostigmine or glycopyrrolate
- Persons with SCI who do not require additional bowel care or have "normal bowel
function"
- Known hypersensitivity to neostigmine or glycopyrrolate
- History of mechanical obstruction of the intestine or urinary tract
- History of Myocardial infarction
- Uncontrollable Hypertension Defined by a blood pressure reading of 160/100 mmHg or
higher
- Organ damage (heart & kidney) and/or transient ischemic attack-cerebral vascular
accident as a result of hypertension
- Known past history of coronary artery disease or bradyarrythmia
- Active respiratory disease
- Known history of asthma during lifetime or recent (within 3 months) respiratory
infections
- Adrenal insufficiency
- Diagnosed coagulopathy
- Any renal disease or dysfunction
- Potential for pregnancy
- Lactating/nursing females
- Slow-heart beat (HR<45 bpm)
- Lack of mental capacity to give consent
- Use of any antibiotic in the past 7 days
- Use of medications known to affect the respiratory system
- Use of medications known to alter airway caliber
- Concurrent participation in other clinical trials (within 30 days)
We found this trial at
1
site
Bronx, New York 10468
Principal Investigator: Mark A. Korsten, MD
Phone: 718-584-9000
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