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

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

Study Overview

• Status: Recruiting
• Conditions: Reconstructive Surgery; Head and Neck Microvascular Free Flap
• Intervention / Treatment: Procedure: free flap surgery

Detailed Description

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).

• Study Type: Observational
• Enrollment (Estimated): 192

Contacts and Locations

• Study Contact: Name: Simone Mauramati; Phone Number: +39 3668734310; Email: s.mauramati@smatteo.pv.it

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Recruiting
      • Fondazione IRCCS Policlinico San Matteo
      • Contact: Simone Mauramati; Phone Number: +39 3668734310; Email: s.mauramati@smatteo.pv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ICU (Intensive Care Unit) Cohort	Procedure: free flap surgery; evaluation of major and minor complications, flap failure rates and length of hospital stay in patients undergoing free flap surgery admitted to intensive care unit and in those admitted to an Otolaryngology specialty ward
non-ICU (Intensive Care Unit) Cohort	Procedure: free flap surgery; evaluation of major and minor complications, flap failure rates and length of hospital stay in patients undergoing free flap surgery admitted to intensive care unit and in those admitted to an Otolaryngology specialty ward

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference in proportions of minor complications in the two groups of patients	the difference in proportions of minor complications in the two groups of patients (ICU compared to a nonICU ward)	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference in proportions of major complications and necrosis in the two groups of patients	the difference in proportions of major complications and necrosis in the two groups of patients (ICU compared to a nonICU ward).	up to 24 months
difference in length of hospitalisation in the two groups of patients	the difference in length of hospitalisation in the two groups of patients (ICU compared to a non ICU ward)	up to 24 months

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2025
• Primary Completion (Estimated): October 13, 2027
• Study Completion (Estimated): October 13, 2027

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: RIA_COMPL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No