Optimising Microsurgical Reconstruction After Advanced Head and Neck Cancers

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• Adult, Older adult

Study population: All patients undergoing surgery and microvascular reconstruction for head and neck cancers. Procedures may be "primary" or for recurrent disease. Patients often suffer from several comorbidities. Most patients have a history of tobacco use. Prognosis is poor and five-year rate of survival is 35-37%.

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Optimising Microsurgical Reconstruction After Advanced Head and Neck Cancers - Enhanced Recovery and Improved Clinical Pathway

Conditions

Head and Neck Cancer

Being tested

Early ambulation, Early oral feeding, Multimodal opioid-sparing analgesia, Goal-directed fluid therapy, CAD/CAM system for reconstructive plates

Keywords

free flap, microsurgery, microvascular reconstruction, Enhanced recovery after surgery, ERAS

Medical subject headings

Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Early ambulationBehavioural

  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.

• Early oral feedingBehavioural

  Also called Focus on nutritional status

  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.

• Multimodal opioid-sparing analgesiaOther

  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.

• Goal-directed fluid therapyProcedure or surgery

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

• CAD/CAM system for reconstructive platesProcedure or surgery

  Also called Minimally invasive surgery

  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.

• Functional discharge criteriaOther

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

• Standard/historical postoperative regimenOther

  Non-formalised historical peri- and postoperative regimen.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Length of stay (LOS)

   Time from surgery to discharge

   Measured: 1 to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted16 Mar 2020
2. Study start1 Jun 2019
3. Primary completion31 Jan 2021 (estimated)
4. Study completion31 Mar 2021 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (8)Papers the sponsor has linked to this study.
• Other trials for Head and Neck CancerStudies of the same condition, open and under way.
• More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.