Anabolic Effects of Intraoperative Feeding in Reconstruction Surgery

A Randomized Trial of Intraoperative Feeding to Ameliorate Catabolic Response in Free Flap Reconstruction Surgery for Head-and-neck Cancer Defect

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms; Complication,Postoperative; Fasting; Hyperglycemia Stress; Stress-related Problem; Muscle Wasting; Catabolic State; Feeding, Time Restricted
• Intervention / Treatment: Dietary supplement: Enteral nutrition formula

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung
    • Yanchao, Kaohsiung, Taiwan, 824
      • E-Da Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Advanced head-and-neck cancer
• Requires radical resection, tracheostomy and free flap reconstruction surgery

Exclusion Criteria:

• Anticipated total operation time < 6h
• Emergency operation
• Bowel obstruction
• Starts nasogastric feeding before operation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Patients assigned to control group will not receive feeding via the nasogastric tube during operation
Experimental: Intraoperative feeding group; Patients assigned to intraoperative feeding group will receive enteral nutrition formula via the nasogastric tube during operation	Dietary supplement: Enteral nutrition formula; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants that have reconstruction flap failure after operation	The definition of flap failure includes vascular occlusion of flap, surgical wound infection or poor healing that requires surgical reintervention	7 days after free flap reconstruction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants that have perioperative complications	The definition of composite perioperative complications during and after operation, include intraoperative hemodynamic stability (hypotension and requirement of inotropes), postoperative insulin sensitivity, glycemic control, skeletal muscle wasting, inflammatory cytokine profiles, length of hospital stay, re-intervention, other postoperative complications, mortality during hospital stay	Start of free flap reconstruction surgery to 28 days after operation

Collaborators and Investigators

• Sponsor: E-DA Hospital
• Investigators: Principal Investigator: Chen-Fuh Lam, MD, PhD, E-Da Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2020
• Primary Completion (Actual): January 10, 2022
• Study Completion (Actual): April 13, 2022

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Hyperglycemia; Head and Neck Neoplasms; Muscular Atrophy; Postoperative Complications
• Other Study ID Numbers: EMRP71108N

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No