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

ConditionsReconstructive SurgeryHead and Neck Microvascular Free Flap
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFondazione IRCCS Policlinico San Matteo di Pavia

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • free flap surgery

    Procedure/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

Treatment groups

192 Participants
are divided into 2 treatment groups
Group A: ICU (Intensive Care Unit) Cohort1 intervention
Group B: non-ICU (Intensive Care Unit) Cohort1 intervention

Trial outcomes

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)

Time frame
up to 24 months

Secondary outcomes

1

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).

Time frame
up to 24 months
2

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)

Time frame
up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione IRCCS Policlinico San Matteo di Pavia

Lead sponsor

Source ClinicalTrials.gov
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