Study of Inhaling Carbon Monoxide to Treat Patients With Intestinal Paralysis After Colon Surgery.
Status:
Terminated
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
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.