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临床试验/NCT07295548
NCT07295548招募中不适用

Postoperative Management of Patients Undergoing Head and Neck Microvascular Free Flap Reconstructive Surgery: is Admission to an Intensive Care Unit Necessary?

Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2025年10月13日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
192
试验地点
1
主要终点
difference in proportions of minor complications in the two groups of patients

研究概览

简要总结

The aim of our study is to assess if patients undergoing head and neck free flap reconstructive surgery admitted to the ICU have equivalent postoperative outcomes to those admitted to an Otolaryngology specialty ward

详细描述

Reconstruction with microvascular free flaps has become the standard of care for various surgical defects in head and neck region. Free flap reconstructive surgery is considered a major surgery with long intraoperative time and critical post-operative care. Close monitoring of the flap viability is of utmost importance especially in the first 48-72 hours after surgery, during which most of the vascular complications could occur; this interval is also critical for eventual successful salvage of an ischemic flap. Despite the delicacy of the matter worldwide there's not yet consensus about which is the most appropriate protocol for postoperative management after free flap surgery. Many patients undergoing free flap surgery are initially admitted to intensive care unit (ICU), even in cases of patients that do not meet any specific indication supporting the need for admission to an ICU setting. There are several reasons to this behaviour but, unfortunately, a post-operative stay in ICU is associated with increased nosocomial infections, complications and costs. The primary aim of this study will be to assess safety and postoperative outcomes (major and minor complications, flap failure rates and length of hospital stay) of patients undergoing reconstructive surgery with microvascular free flaps admitted to ICU compared to a non-ICU ward.The primary objective is to identify in which group of patients minor complications are more frequently encountered (complications that do not require surgical treatment in the operating room are considered as minor).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • patients undergoing Head and Neck oncological demolitive surgery and reconstruction using free or pedicled flaps at the Fondazione IRCCS Policlinico San Matteo, Pavia

排除标准

  • patients treated for Head and Neck cancer without flap reconstruction (e.g., only chemotherapy-radiotherapy, only radiotherapy, only immunotherapy).

结局指标

主要结局

difference in proportions of minor complications in the two groups of patients

时间窗: up to 24 months

the difference in proportions of minor complications in the two groups of patients (ICU compared to a nonICU ward)

次要结局

  • difference in proportions of major complications and necrosis in the two groups of patients(up to 24 months)
  • difference in length of hospitalisation in the two groups of patients(up to 24 months)

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Simone Mauramati

Principal Investigator

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (1)

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