Neurostimulation for the Treatment of Post-Operative Ileus
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Illinois
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Chicago, Illinois, Forente stater, 60611
- Northwestern
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Maryland
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Baltimore, Maryland, Forente stater, 21205
- Johns Hopkins Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19106
- Pennsylvania Hospital
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: 2
Subject will be observed until recovery of normal GI function
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|
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Eksperimentell: 1
Spinal neurostimulation
|
An electrical neurostimulation signal will be applied to the spine
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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
Tidsramme: 30 days
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30 days
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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.
Tidsramme: 48 hours
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48 hours
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Michael Erdeck, MD, Johns Hopkins Medical Center
- Hovedetterforsker: David Walega, MD, Northwestern University Medical Center
- Hovedetterforsker: Robert Frye, MD, Pennsylvania Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IL - 01
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