Status:
WITHDRAWN
Neurostimulation for the Treatment of Post-Operative Ileus
Lead Sponsor:
ElectroCore INC
Conditions:
Ileus
Eligibility:
All Genders
18-65 years
Phase:
NA
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 sp...
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 studie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00854074
Start Date
July 1 2009
End Date
January 1 2010
Last Update
February 19 2018
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Northwestern
Chicago, Illinois, United States, 60611
2
Johns Hopkins Medical Center
Baltimore, Maryland, United States, 21205
3
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19106