NCT02574611

Use of High Resolution Colonic Manometry in Studying Motility

Safety and Efficacy of High Resolution Manometry in Studying Colonic Motility and Iontophoretic Administration of Prokinetic Agents

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: James J. Peters Veterans Affairs Medical Center · Federal
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Gastrointestinal Dysfunction

Interventions

Type	Name	Description
DRUG	Neostigmine
DRUG	Glycopyrrolate
OTHER	Saline (Placebo)
DEVICE	High Resolution Colonic Manometry

Timeline

• Start date: 2015-10-13
• Primary completion: 2017-12-25
• Completion: 2018-12-25
• First posted: 2015-10-14
• Last updated: 2021-09-28

Locations

1 site across 1 country: United States