Head and Neck Neoplasms Clinical Trial
Official title:
A Randomized Trial of Intraoperative Feeding to Ameliorate Catabolic Response in Free Flap Reconstruction Surgery for Head-and-neck Cancer Defect
Verified date | April 2022 |
Source | E-DA Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 13, 2022 |
Est. primary completion date | January 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | E-Da Hospital | Yanchao | Kaohsiung |
Lead Sponsor | Collaborator |
---|---|
E-DA Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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