Hippocration General Hospital of Athens
Athens, Greece
NCT Number: NCT06737211
Major surgical operations of the gastrointestinal tract, such as colorectal resections due to several diseases, lead to significant burden on the human body, which is expressed during the first postoperative hours with an intense inflammatory reaction and consumption of a large amount of energy, increasing nutritional requirements of the patients. Therefore, specific protocols have been implemented for the early initiation of oral feeding in patients undergoing colorectal resections. However, it is not feasible for every patient to meet them due to several reasons, such as old age and associated pathophysiological changes, use of opioid drugs for the management of postoperative pain, which is associated with postoperative ileus or nausea, as well as open resection which lead to gastrointestinal impairment during the first postoperative days. The energy deficit that occurs during the early postoperative period, which appears to be associated with adverse clinical outcomes, can be counterbalanced by the administration of parenteral nutrition. However, the conventional way of administration through central venous lines is associated with significant complications. For this reason, administration of parenteral nutrition through a peripheral venous catheter could be used alternatively, which avoids morbidity and has been also effective in maintaining the patients' energy balance, even during the first postoperative hours. Therefore, the main purpose of the present study is to investigate the efficacy of the administration of peripheral parenteral nutrition on the postoperative outcomes of patients undergoing colorectal resections. Moreover, the correlation of the administration of peripheral parenteral nutrition with the reaction to post-operative stress and with the nutritional status of the patients post-operatively, which are determining factors for the clinical course of these patients, will be investigated.
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Notify Me18 year–95 year
All sexes
Interventional
Not applicable
Athens, Greece
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2000 mL of peripheral parenteral nutrition with electrolytes (20 mL 7.45% KCl, 10 mL 20% MgSO4 and 20 mL 8.7% Na3PO4) will be administered via a peripheral venous catheter with a rhythm of 80cc/h from the time they will leave the operation room and will be transferred to the ward or the critical care unit (CCU) until the 5th postoperative day
Time frame: 5 postoperative days
Serum nutritional markers and acute phase proteins indicating postoperative surgical stress response.
Time frame: 90 postoperative days
Complications after surgery and their classification according to Calvin-Dindo score.
Time frame: 30 postoperative days
Postoperative day of nasogastric tube removal
Time frame: 30 postoperative days
Postoperative day of feeding start
Time frame: 30 postoperative days
Postoperative day of mobilization
Time frame: 30 postoperative days
Utilization of epidural sparing catheter
Time frame: 30 postoperative days
Thrombophlebitis, hyperglycemia, re-feeding syndrome
National and Kapodistrian University of Athens
Other
Optimizing Postoperative Nutrition in Colorectal Surgery: a Prospective Randomized Clinical Trial.
Acronym: OPTI-NUTRICS
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