TerminatedPhase 2

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

Stopped: According to retired PI, resident graduated and next resident never carried it to fruition.

Canada3 participantsStarted 2011-04

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men and women, age \> 18 years. * Women must be using acceptable contraceptives, post-menopausal or surgically sterile. * No prior smoking history. * BMI between 16 and 30 inclusive. * No significant abnormalities on history, physical examination or laboratory parameters. Exclusion Criteria: * Exposure to any carbon monoxide source during the 48 hours prior to the study day or occupational exposure to CO. * Significant disease or disorder (as explained in Study B). * Complete bowel obstruction. * Intra-abdominal inflammation (diverticulitis, inflammatory bowel disease, colitis). * Retroperitoneal hematomas. * Known GI motility disorder. * Underlying lung disease such as pneumonia, asthma or COPD. * Sepsis. * Planned pregnancy, already pregnant or breastfeeding. * Electrolyte disturbance (hypokalemia, hypomagnesemia, hyponatremia). * Significant opioid and laxative use 4 weeks prior to surgery. * Anti-inflammatory use 2 days prior to surgery. * Drugs such as antacids, Coumadin, amitriptyline, chlorpromazine. * Baseline oxygen saturation \<92% on room air. * Baseline blood level of COHb \>2%. * Baseline hemoglobin \<90 g/dL. * Participation in another clinical trial within 2 months prior to study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Duration of post operative ileus (radiologic)

Timeframe: 1 week

Incidence of pathological post operative ileus

Timeframe: 1 week

Duration of post operative ileus (clinical)

Timeframe: 1 week

Trial details

NCT IDNCT01050712

SponsorQueen's University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-09

View on ClinicalTrials.gov More Ileus trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.