Study of Inhaling Carbon Monoxide to Treat Patients With Intestinal Paralysis After Colon Surgery.
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Inhaled Carbon Monoxide in Patients With Post-Operative Ileus Following Colon Resection.|
- Duration of post operative ileus (radiologic) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- Incidence of pathological post operative ileus [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- Duration of post operative ileus (clinical) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
|Experimental: Carbon Monoxide||
Drug: Inhaled Carbon Monoxide
Concentration of Carbon Monoxide to be inhaled by patients will be determined in a safety trial performed in healthy volunteers prior to the commencement of this trial. Patients randomized to received inhaled carbon monoxide will receive this concentration by cushioned face mask for one hour prior to colon resection and for one hour after colon resection
|Placebo Comparator: Synthetic Air||
Drug: Synthetic Air
Patients randomized to this intervention will receive this gas via cushioned face mask for one hour prior to colon resection and for one hour after colon resection
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050712
|Contact: Paul J Belliveau, MDMA, MPA, FRCSC||613-544-3400 ext email@example.com|
|Kingston General Hospital||Recruiting|
|Kingston, Ontario, Canada, K7L 2V7|
|Contact: Paul Belliveau firstname.lastname@example.org|
|Sub-Investigator: Abigail D`Sa, MD|
|Sub-Investigator: Kanji Nakatsu, PHD|
|Sub-Investigator: Graeme Smith, MD|
|Principal Investigator: Paul Belliveau, MD|
|Principal Investigator:||Paul J Belliveau, MD||Queen's University|