Clinical trial NCT00854074: Neurostimulation for the Treatment of Post-Operative Ileus
Official title: Neurostimulation for the Treatment of Post-Operative Ileus
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ileus
Keywords: Post-operative Paralytic Ileus
Neuromodulation
Neurostimulation
Extended loss of functional bowel motility
Lead sponsor: ElectroCore INC
Sponsor class: INDUSTRY
First posted: 2009-03-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: 30 days
Secondary outcomes:
measure: 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.
timeFrame: 48 hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Medical Center
state: Maryland
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: Johns Hopkins Medical Center
name: Michael Erdeck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University Medical Center
name: David Walega, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pennsylvania Hospital
name: Robert Frye, MD
role: PRINCIPAL_INVESTIGATOR
References: