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

NCT07295548 | Recruiting

• 1 other identifier: RIA_COMPL
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Reconstructive Surgery; Head and Neck Microvascular Free Flap

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

ICU (Intensive Care Unit) Cohort

Procedure: free flap surgery

non-ICU (Intensive Care Unit) Cohort

Procedure: free flap surgery

Interventions

free flap surgery PROCEDURE

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

ICU (Intensive Care Unit) Cohort; non-ICU (Intensive Care Unit) Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

RECRUITING

Central Study Contacts

Simone Mauramati

CONTACT

+39 3668734310; s.mauramati@smatteo.pv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 19, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): October 13, 2027
• Study Completion (Estimated): October 13, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-11

Locations

IT (1)