Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Catabolic State | — | UNRESOLVED | — |
| Complication,Postoperative | — | UNRESOLVED | — |
| Fasting | — | UNRESOLVED | — |
| Feeding, Time Restricted | — | UNRESOLVED | — |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Hyperglycemia Stress | — | UNRESOLVED | — |
| Muscle Wasting | — | UNRESOLVED | — |
| Stress-related Problem | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enteral nutrition formula | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control group
- description
- Patients assigned to control group will not receive feeding via the nasogastric tube during operation
- type
- EXPERIMENTAL
- label
- Intraoperative feeding group
- description
- Patients assigned to intraoperative feeding group will receive enteral nutrition formula via the nasogastric tube during operation
- interventionNames
- Dietary Supplement: Enteral nutrition formula
Primary outcomes (1)
- measure
- Number of participants that have reconstruction flap failure after operation
- timeFrame
- 7 days after free flap reconstruction
- description
- The definition of flap failure includes vascular occlusion of flap, surgical wound infection or poor healing that requires surgical reintervention
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHwang 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. PMID 36960779