Neurostimulation for the Treatment of Post-Operative Ileus

Study Overview
=================
Brief Summary
-----------------
The primary goal of this study is to validate the design of the ElectroCore RMS-1100 Resolution Motility System™ and the ability to safely place a stimulation electrode in the epidural space of the spine in a post-operative subject, and to evaluate the subject's ability to tolerate stimulation for up to 48 hours. The secondary goal is to confirm that the electrical signal being delivered via this electrode shows evidence of effectiveness in improving the functional GI motility in subjects experiencing post-operative paralytic ileus

Detailed Description
-----------------
The purpose of this study is to investigate the effects of neurostimulation in the epidural space in the spine on the activity of the enteric nervous system (ENS). ElectroCore has successfully studied POI in an animal model and believes that temporary neurostimulation of the spine may be useful in re-starting the ENS in humans, resulting in the resumption of coherent GI motility in the gut and normal bowel function in a shorter period of time than currently occurs. Electrical pulses will be used to modulate the signals that may be preventing a return to normal GI activity. This device and procedure used in this study are similar to the system and procedure used to implant the temporary trial stimulator used evaluate the effectiveness of spine pain stimulation prior to implantation of the permanent device.

Official Title
-----------------
Neurostimulation for the Treatment of Post-Operative Ileus

Conditions
-----------------
Ileus

Intervention / Treatment
-----------------
* Device: ElectroCore RMS-1100 Resolution Motility System™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female, Age >18 years, < 65 years Partial small or large bowel open resection with primary anastomosis 120 hours post-operative with no signs of functional bowel activity Able to give Informed Consent By Post-Op Day 5, patient care has involved at least 3 of the following conservative therapies to minimize long term POI: i. post-operative, patient controlled opioid analgesia ii. removal of intra-operative nasogastric tube at time of surgery or on post-operative day 1 iii. advancement of liquid diet iv. advancement of solid food v. ambulation vi. use of chewing gum Exclusion Criteria: Pregnant Undergoing surgery for repair of penetrating trauma injury, gangrene or ischemic bowel Evidence of anastomotic leak, abdominal infection, sepsis, bowel perforation, mechanical small bowel obstruction or metabolic derangement (e.g., low potassium/magnesium) Presence of existing implanted or external stimulator for pain or other indications (including pacemaker) Operative blood lost of > 500 cc Significant scarring of the skin along the lower thoracic/lumbar spine or deformation of thoracic spinal canal from congenital, developmental or traumatic causes, or previous extensive spinal thoracic surgery other than diskectomy Received a lumbar or thoracic epidural block placed immediately prior to surgery Body Mass Index > 35 Unstable cardiac status Severe hypertension American Society of Anesthesiologists (ASA) Score greater than/equal to 3 On anti-coagulation therapy (other than aspirin) or has an underlying bleeding disorder Active or suspected pelvic infection Unable to communicate perception of the stimulation Significant surgical complications where in the view of the physician, participation in the study could further complicate subject care (i.e. infection at surgical site, deep venous thrombosis, respiratory complications, etc) Treatment with Entereg (alvimopam) during post-operative period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 2<br>Subject will be observed until recovery of normal GI function | |
| Experimental: 1<br>Spinal neurostimulation | Device: ElectroCore RMS-1100 Resolution Motility System™<br>* An electrical neurostimulation signal will be applied to the spine<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To validate the design of ElectroCore Resolution Motility System™ , to safely place a stimulation electrode in the epidural space of the spine in a post-operative subject, and to evaluate the subject's ability to tolerate stimulation for up to 48 hours |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To confirm that the electrical signal being delivered via this electrode shows evidence of effectiveness in improving the functional motility in subjects experiencing post-operative paralytic ileus. |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post-operative Paralytic Ileus, Neuromodulation, Neurostimulation, Extended loss of functional bowel motility