Jinling Hospital, China
Nanjing, Jiangsu, 210002, China
NCT Number: NCT03117348
Patients will be randomized to Gradual or immediate Goal-dose EN group at day 3 after abdominal surgery. Patients will receive Goal-dose EN gradually or immediately after abdominal surgery. Both groups will receive EN for 5 days except 80% of target energy delivered by oral feeding or patients are discharged from hospital. The primary and secondary outcomes will be collected.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Nanjing, Jiangsu, 210002, China
Patients after abdominal surgery will receive enteral nutrition for 2 days, if she/he can tolerate 30% of goal-dose EN, then she/he will be randomized to Gradual or immediate Goal-dose EN group at day 3. Patients in Gradual Goal-dose EN group will receive increased calories gradually by EN and will reach the 80% of target energy by EN at day 8 while patients in immediate Goal-dose EN group will receive 100% of target energy by EN at day 3 after abdominal surgery. Both groups will receive EN for 5 days except 80% of target energy delivered by oral feeding or patients are discharged from hospital, whichever arrives first. The primary and secondary outcomes will be collected.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients in Gradual Goal-dose EN group will receive increased calories gradually by EN and will reach the 80% of target energy by EN at day 8 while patients in immediate Goal-dose EN group will receive 100% of target energy by EN at day 3 after abdominal surgery. Both of the two group will receive EN for 5 days except 80% of target energy delivered by oral feeding or patients are discharged from hospital, whichever arrives first.
Time frame: From date of randomization until the date of infection from any cause, assessed up to 2 months.
Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.
Time frame: During the intervention, assessed up to 2 months.
The total energy patients received during the intervention.
Time frame: During the intervention, assessed up to 2 months.
Diarrhea, vomiting, abdominal distention or cramping and abdominal pain.
Time frame: At the date of patients enrollment and after intervention, assessed up to 2 months.
Albumin, pre-albumin, transferrin and retinol conjugated protein
Time frame: From date of operation until the date of patients discharged from hospital, assessed up to 12 months.
The length of patients stay in hospital
Time frame: From date of randomization until the date of death, assessed up to 2 months after patients discharged from hospital.
All deaths reported in all enrolled patients.
Jinling Hospital, China
Other
Gradual Versus Immediate Goal-dose Enteral Nutrition in Abdominal Surgery Patients: A Clinical Randomized Controlled Trial
Acronym: GIGENAS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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