Anabolic Effects of Intraoperative Feeding in Reconstruction Surgery

NCT ID: NCT04266015

Last Updated: 2022-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-16
• Study Completion Date: 2022-04-13

Brief 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.

Conditions

Fasting; Feeding, Time Restricted; Stress-related Problem; Head and Neck Neoplasms; Catabolic State; Hyperglycemia Stress; Muscle Wasting; Complication,Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

Patients assigned to control group will not receive feeding via the nasogastric tube during operation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intraoperative feeding group

Patients assigned to intraoperative feeding group will receive enteral nutrition formula via the nasogastric tube during operation

Group Type: EXPERIMENTAL

Enteral nutrition formula

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

E-DA Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tu, Yuan-Kun

Superintendent, professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chen-Fuh Lam, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

E-Da Hospital, Taiwan

Locations

E-Da Hospital

Yanchao, Kaohsiung, Taiwan

Countries

Taiwan

References

Hwang TZ, Wang YM, Jeng SF, Lee YC, Chen TS, Su SY, Huang CC, Lam CF. Intraoperative Enteral Nutrition Feeding in Free-Flap Healing after Reconstruction Surgery for Head and Neck Cancers. Otolaryngol Head Neck Surg. 2023 Oct;169(4):843-851. doi: 10.1002/ohn.335. Epub 2023 Mar 24.

Reference Type: DERIVED

PMID: 36960779 (View on PubMed)

Other Identifiers

EMRP71108N

Identifier Type: -

Identifier Source: org_study_id