GDFT on the Postoperative Outcome in Head and Neck Cancer Surgery

Not Applicable

Recruiting

• Conditions: Postoperative Complications

• Registration Number: NCT06468852
• Lead Sponsor: Beijing Tongren Hospital

Brief Summary

The goal of this clinical trial is to evaluate whether goal-directed fluid therapy (GDFT) can improve the postoperative recovery in patients undergoing head and neck cancer surgery. It aims to answer is:

• Whether GDFT can reduce the occurrence of serious postoperative complications? Researchers will compare GDFT protocol to a standard conventional fluid therapy in head and neck cancer surgery to see if GDFT strategy works to improve the postoperative recovery.

Participants will

* Receive GDFT protocol or a conventional fluid therapy during the surgery.

* Be continuously follow-up during hospitalization and after discharge to record the occurrence of postoperative complications.

Detailed Description

Postoperative complications have become the main cause of prolonged hospitalization and reduced postoperative survival rate among surgical patients. Goal-Directed Fluid Therapy (GDFT) has been reported to reduce the incidence of postoperative complications and mortality, shorten the hospital stay, and improve the outcome in major abdominal surgery patients. However, the benefit of the GDFT in patients undergoing head and neck surgery remains controversial. The purpose of this study is to evaluate whether GDFT can reduce the occurrence of serious postoperative complications and shorten the postoperative hospital stay, compared with a standard conventional fluid therapy in patients undergoing head and neck cancer surgery.

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-16
• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-16
• Last Update Submitted: 2024-06-16
• Study First Posted: 2024-06-21
• Last Update Posted: 2024-06-21
• Primary Completion: 2026-04-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

• Adult patients (Age≥18)
• Scheduled to undergo head and neck cancer surgery (including nasopharyngeal carcinoma, laryngocarcinoma, hypopharyngeal carcinoma, and other head and neck malignancies, but not thyroid cancer) with an expected duration of 2 hours or longer
• Agree to receive invasive artery blood pressure monitoring

Exclusion Criteria

• American Society of Anesthesiologists (ASA) classification>Ⅳ
• Palliative surgery was performed for the terminal tumors
• Microlaryngoscopic laser surgery or endoscopic surgery
• Underwent major thoracic or abdominal surgery within 30 days
• Regular renal replacement therapy is required
• NYHA grade>3 or ejection fraction <30%
• Lung disease does not tolerate the tidal volume by 8 ml/kg
• Atrial fibrillation
• Unable to give informed consent
• pregnant or lactating woman
• Emergency surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Serious complications occurred within 30 days after surgery	within 30 days after surgery	Unit: %; All postoperative complications will be evaluated according the Clavien-Dino classification(CDc) of surgical complications. Each complication has an equal weight, and patients with at least one complication will be considered to have experienced postoperative complications.; The serious postoperative complications were defined as CDc≥3.

Secondary Outcome Measures

Name	Time	Method
All complications within 30 days after surgery	within 30 days after surgery	Unit: %;All postoperative complications will be evaluated according the Clavien-Dino classification(CDc) of surgical complications.
Cost of hospitalization	1 months after operation	Unit: yuan; Total cost during hospitalization
The length of hospital stay after surgery	1 months after operation	Unit: days; from date of operation till date of discharge
Quality of Recovery Score	At 1,3, and 5 days after surgery	Unit: point; Use QoR-15 to evaluate the postoperative recovery of all patients. QoR-15 is a global measure of recovery after surgery that evaluates five dimensions of recovery: physical comfort (5 items), physical independence (2 items), emotional state (4 items), psychological support (2 items), and pain (2 items). Each item is rated on an 11- point scale based on its frequency on the questionnaire (greater score at greater frequency for positive items and less frequency for negative items). The total score ranged from 0 (poorest recovery quality) to 150 (best recovery quality).

Trial Locations

Locations (1)

Beijing tongren Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China