Optimising Microsurgical Reconstruction After Advanced Head and Neck Cancers

Summary

This study aims to improve the peri- and postoperative care regimen for patients undergoing microvascular reconstruction after head and neck cancer by introducing an enhanced recovery after surgery (ERAS) programme.

Conditions

• Head and Neck Cancer

Interventions

BEHAVIORAL

Early ambulation

Early ambulation will help prevent postoperative infections, especially pneumonia and urinary tract infections. Additionally it will prevent constipation by promotion of bowel-movement and function and prevent thromboembolic complications. Patients undergoing surgery with a free fibula flap are currently unable to ambulate for 6 to 7 days while a split-thickness skin-graft is healing. We will apply a pressure dressing to the wound which makes ambulation possible immediately after surgery (or after return from the ICU). Likewise, all other patient groups will be encouraged to fully ambulate on POD (post-operative day) 1 or POD 2.

BEHAVIORAL

Early oral feeding

To monitor the patients' nutritional status, blood samples will be taken to identify risk of refeeding syndrome and patients will be evaluated according to the current guidelines from the ENT (ear-, nose-, throat-) department. We wil use the ESPEN guidelines for nutritional risk screening (NRS-2002), which have been validated for head and neck cancer patients to perform a risk assessment for malnutrition. A consultation with a clinical dietician will be arranged in order to calculate the required daily nutritional intake. Patients in risk of refeeding syndrome will be closely monitored in the outpatient clinic during the time from the MDT(Multi Disciplinary Team) conference to the day of surgery. Patients in need of additional nutritional support will be provided with supplementary energy/protein drinks. Some patients may need closer monitoring, guidance regarding extra meals and to have a nasogastric tube placed to get used to the tube and optimize pre-operative nutritional status.

OTHER

Multimodal opioid-sparing analgesia

On-label use of already approved drugs including perioperative dexamethasone, administered with the aim of reducing opioid intake. Pre-operatively the patients are given 400 mg of Celebra. During surgery 24 mg of dexamethasone is administered. The post-operative regimen consists of 12 mg of Dexamethasone 48 and 96 hours post-operatively, 200 mg of Celebra morning and evening (maximum 14 days) and 1g of paracetamol times four times daily. Morphine will only be administered when assessed necessary with a dose of 10 mg p.n. maximum six times a day.

PROCEDURE

Goal-directed fluid therapy

Focus on avoidance of over-hydration. Aim for fluid-load after surgery: max: +1000-1500 ml

PROCEDURE

CAD/CAM system for reconstructive plates

Computer-assisted design and modelling (CAD/CAM) are a system for pre-operative planning and construction of reconstructive plates used for mandibular reconstruction. This will help reduce the operating-time, as the maxillofacial surgeon will bring a pre-bent reconstructive plate to the procedure instead of manually forming it during surgery. Already implemented for several procedures in the department.

OTHER

Functional discharge criteria

Introduction of a number of functional discharge criteria to avoid prolonged postoperative hospitalisation

OTHER

Standard/historical postoperative regimen

Non-formalised historical peri- and postoperative regimen.

Sponsors & Collaborators

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Jens H Hojvig, Md · Rigshospitalet, Denmark

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-01

Primary Completion

2021-01-31

Completion

2021-03-31

Countries

• Denmark

Study Locations