MedDataX Logo

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

NCT ID: NCT07295548

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-13

Study Completion Date

2027-10-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Reconstructive Surgery Head and Neck Microvascular Free Flap

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ICU (Intensive Care Unit) Cohort

free flap surgery

Intervention Type 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

non-ICU (Intensive Care Unit) Cohort

free flap surgery

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Simone Mauramati

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Simone Mauramati

Role: CONTACT

Phone: +39 3668734310

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Simone Mauramati

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RIA_COMPL

Identifier Type: -

Identifier Source: org_study_id