Effect of Intravenous Nutrition and Epidural Analgesia on Protein Loss After Surgery (NCT00614133) | Clinical Trial Compass
CompletedNot Applicable
Effect of Intravenous Nutrition and Epidural Analgesia on Protein Loss After Surgery
Canada22 participantsStarted 2004-06
Plain-language summary
Loss of muscle mass and body protein are the main causes of fatigue after bowel surgery, which may result in a longer hospital stay and a higher rate of complications. This particularly applies to malnourished patients with cancer who undergo surgery with less muscle protein reserves than patients who are well-nourished. Anesthesiologists can favourably influence these undesirable consequences of surgery by choosing the type of pain treatment, i.e. analgesia. Our group recently observed that pain treatment with epidural catheters (these are placed in the so called epidural space, which lies between the spine and the skin of the back), in contrast to the more conventional use of intravenous morphine, can prevent the loss of body protein after surgery.
The goal of the present research program is to study whether this protein sparing effect of epidural analgesia can be further augmented if we feed our patients intravenously with glucose and protein starting the day prior to surgery. We believe that this new concept will not only avoid the increased protein loss after surgery, but will also help patients to build up new protein which is needed to fight the stress caused by the operation.
Who can participate
Age range
18 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:
* American Society of Anesthesiologists \<3
* colorectal surgery for non-metastatic colorectal carcinoma including right and left hemicolectomy, transverse, subtotal and total colectomy, sigmoid resection
* ability to give informed consent
Exclusion Criteria:
* signs of severe malnutrition or obesity: body mass index \<18 or \>25 \>10% involuntary body weight loss over the preceding 6 months serum albumin \<21 g/L
* significant cardiorespiratory, hepatic, renal and neurological disease
* ingestion of drugs known to affect protein, glucose and lipid metabolism (for example steroids)
* musculoskeletal or neuromuscular disease
* severe anemia (hemoglobin \<10 g/dL)
* pregnancy
* history of severe sciatica or back surgery or other conditions which contraindicate the use of epidural catheters
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
1
protein balance
Timeframe: two days after surgery
Trial details
NCT IDNCT00614133
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre