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Study of Inhaling Carbon Monoxide to Treat Patients With Intestinal Paralysis After Colon Surgery.

2014-08-27 03:16:34 | BioPortfolio

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Ileus

Intervention

Inhaled Carbon Monoxide, Synthetic Air

Location

Kingston General Hospital
Kingston
Ontario
Canada
K7L 2V7

Status

Not yet recruiting

Source

Queen's University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:34-0400

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