Ileus Clinical Trial
Official title:
Inhaled Carbon Monoxide in Patients With Post-Operative Ileus Following Colon Resection.
Post operative ileus (POI), a temporary paralysis of the intestines, is a serious health
care problem. It normally occurs in all patients after surgery to the abdomen but in some
cases can result in serious complications. The objective of this study is to determine if
inhaling very low doses of carbon monoxide (CO) before and after colon surgery will shorten
the duration of normal POI and/or prevent the development of POI complications in patients
undergoing colon surgery.
A preliminary study will be conducted in six healthy volunteers to monitor for blood levels
and adverse effects that occur at 3 different doses of inhaled CO to establish a safe dose
for patients in the main trial. For the main trial, patients requiring surgery to their
colon will be assigned randomly to receive one hour treatments of either CO or oxygen by
face mask before and after their operation. Length of normal POI and occurrence of POI
complications will be compared between the two groups. Side effects that occur from inhaling
CO or oxygen will also be recorded.
We hypothesize that inhaling CO before and after colon surgery will shorten the length of
normal POI and decrease the occurrence of POI complications with minimal side effects.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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