Clinical Research Directory

Energy Expenditure Assessment in Head and Neck Cancer Patients Treated With Free Flap Surgery

What is the purpose of this study? Patients with head and neck cancer who undergo surgery with free flap reconstruction often need careful nutritional support during recovery. The purpose of this study is to better understand how much energy (calories) these patients need before and after surgery and whether nutrition is related to recovery, complications, and overall outcomes. Who can participate? Adults (18 years and older) with head and neck cancer who are scheduled to undergo free flap reconstructive surgery at Tel Aviv Sourasky Medical Center may be invited to participate. What will participants do? Participants will undergo several nutrition-related assessments before and after surgery, including: Indirect calorimetry tests, which measure how much energy the body uses. Body composition measurements using a non-invasive device. A questionnaire about food intake. Collection of routine clinical information, laboratory results, and recovery data from medical records. The indirect calorimetry assessments will be performed before surgery, several days after surgery, before hospital discharge, and approximately one month after discharge. What are the possible benefits of the study? The information obtained may help researchers better understand the nutritional needs of patients with head and neck cancer undergoing major surgery. This knowledge may improve nutritional care and recovery for future patients. Will participation affect medical care? Participation in the study will not change the standard medical or nutritional care patients receive. Nutritional follow-up will continue according to routine clinical practice. How will privacy be protected? Study data will be stored in a coded form, and access will be limited to authorized study personnel. Personal identifying information will be kept separate from the research database.

Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction (VISION Trial)

This is a prospective multicentre randomised controlled trial evaluating whether intraoperative indocyanine green (ICG) fluorescence angiography improves outcomes in head and neck free flap reconstruction compared with standard clinical assessment of flap perfusion. Adult patients undergoing microvascular free flap reconstruction for oncologic, trauma, or benign head and neck defects will be randomised to either intraoperative ICG angiography or conventional clinical perfusion assessment. The primary outcome is partial flap loss requiring intervention within 30 days after surgery. Secondary outcomes include total flap loss, flap-related re-exploration, flap salvage, and postoperative complications.

Effect of Dezocine Versus Nalbuphine Combined With Sufentanil on Postoperative Analgesia, Complications, and Free Flap Survival in Patients Undergoing Oral Cancer Radical Surgery: A Randomized Controlled Clinical Trial.

Background: Oral cancer radical surgery often requires free flap reconstruction. Postoperative pain is severe, and traditional opioids like sufentanil have side effects and may adversely affect tumor biology. Dezocine and nalbuphine are opioid agonist-antagonists with potentially better safety profiles. Their comparative effects on analgesia, complications, and flap survival in oral cancer surgery are unknown. Objective: To compare the efficacy of dezocine versus nalbuphine, both combined with sufentanil, for postoperative analgesia, and to evaluate their impact on postoperative complications and free flap survival/function in patients undergoing oral cancer radical surgery with flap reconstruction. Methods: This is a prospective, randomized, double-blind, controlled trial. Sixty eligible patients (aged 18-70, ASA I-III) will be randomly assigned (1:1) to receive postoperative patient-controlled intravenous analgesia (PCIA) with either Sufentanil + Dezocine or Sufentanil + Nalbuphine. The primary outcome is pain intensity assessed by the Visual Analogue Scale (VAS) at 2, 24, and 48 hours postoperatively. Secondary outcomes include flap survival status, sensory function recovery, incidence of adverse events (e.g., nausea, vomiting), and hospitalization duration. Potential Impact: This study may identify a superior postoperative analgesic regimen that provides effective pain relief while potentially improving flap outcomes and minimizing side effects for oral cancer patients.