Anabolic Effects of Intraoperative Feeding in Reconstruction Surgery
Condition: Fasting; Feeding, Time Restricted; Stress-related Problem; Head and Neck Neoplasms; Catabolic State; Hyperglycemia Stress; Muscle Wasting; Complication,Postoperative
MeSH terms: Head and Neck Neoplasms; Muscular Atrophy; Hyperglycemia; Postoperative Complications
Study type: Interventional

Summary: 
      Perioperative fasting remains a common clinical practice in surgical patients to prevent the
      development of postoperative anesthesia- and surgical-related complications. Clinical
      observational studies indicated that the combination catabolic effects resulted from
      prolonged perioperative fasting and profound surgical stress are likely to induce extensive
      protein catabolism, muscle breakdown and impaired glycemic control during postoperative
      phase, leading to the development of severe complications. Furthermore, prolonged
      gastrointestinal fasting is associated with microbial translocation that deteriorates the
      early recovery after surgery. This clinical trial anticipates in determining the beneficial
      effect of intraoperative feeding to improve intraoperative hemodynamics and enhance
      postoperative recovery due to attenuation of systemic catabolism and improvement of insulin
      sensitivity to glycemic control.
    

Detailed description: 
      Perioperative fasting remains a common clinical practice in surgical patients, aiming to
      prevent pulmonary aspiration during anesthesia induction, improve bowel preparation, and
      ameliorate the development of postoperative nausea/vomiting or other surgical-related
      complications. Major head-and-neck tumor excision and reconstruction surgery is one of the
      most time-consuming surgeries that usually takes more than 12 h to complete. In addition to
      the preoperative fasting and postoperative recovery time periods, most of these patients will
      be fasted for more than 24-36 h before they are fed via nasogastric tubes in the
      postoperative care units. The combination catabolic effects resulted from prolonged
      perioperative fasting and profound surgical stress are likely to induce extensive protein
      catabolism, muscle breakdown and impaired glycemic control during postoperative phase. These
      catabolic responses may lead to the development of post-operative surgical site infection,
      delayed wound healing, re-intervention, cardiac arrest, and death in diabetic and
      non-diabetic patients. Furthermore, prolonged gastrointestinal fasting is associated with
      dehydration, perturbed gut integrity/permeability (leaky gut) and microbial (bacterial)
      translocation that deteriorates the early recovery after reconstruction surgery. The aim of
      this clinical trial is to test the effect of intraoperative feeding in patients receiving
      head-and-neck tumor excision and reconstruction surgery, and anticipate that reduction of
      perioperative fasting time may improve intraoperative hemodynamics and enhance postoperative
      recovery due to attenuation of systemic catabolism and improvement of insulin sensitivity to
      glycemic control.

      This single-center clinical trial will be undertaken in a randomized, double-blind,
      placebo-controlled fashion, in which patients with advanced head-and-neck tumor who are
      scheduled for extended tumor resection and free-flap reconstruction will be randomly assigned
      to receive control (no intraoperative feeding) or intraoperative feeding group. Feeding via
      the nasogastric (NG) tube will start after the establishment of tracheostomy and completion
      of tumor resection at fusion rate of 10-30 ml/h (feeding diet 1 Kcal/ml and 0.04 g
      protein/ml). This trial anticipates in detecting differences in intraoperative hemodynamic
      stability and development of major postoperative complications, including delayed wound
      healing, surgical site infections and insulin-resistant hyperglycemia between controls and
      intraoperative feeding group. The outcomes of this clinical trial may provide fundamental
      evidence for vigorous enteric nutrition and energy support during prolonged high surgical
      stress operation.
    

Intervention name(s): Enteral nutrition formula
Intervention type(s): Dietary Supplement
Intervention description(s): Intervention group will receive nasogastric feeding with commercially available liquid enteral diet (250 ml/can, Kcal/ml, 10.4 g protein/can) during free flap reconstruction at feeding rates 10-30 ml/h.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized double-blind controlled trial
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment