Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04266015 |
Other study ID # |
EMRP71108N |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 16, 2020 |
Est. completion date |
April 13, 2022 |
Study information
Verified date |
April 2022 |
Source |
E-DA Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.