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Optimising Microsurgical Reconstruction After Advanced Head and Neck Cancers

21 marzo 2020 aggiornato da: Jens Hjermind Højvig, Rigshospitalet, Denmark

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

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.

Panoramica dello studio

Descrizione dettagliata

Advanced stage head and neck cancers have a poor prognosis and a 5-year survival rate of as low as 35-37%. The treatment is complex and often requires a multidisciplinary approach including surgery. The goal besides removal of the cancer is to restore function and appearance. If possible, both resection as well as immediate reconstruction will be performed during the same surgical procedure. Due to the large bone- and soft tissue loss following the ablative procedure, local solutions are often inadequate for reconstruction. In addition, many patients require post-operative radiotherapy, which may result in tightness of scar tissue and impaired function. In these cases it is necessary to perform the reconstruction using a free flap.

Free flap reconstruction involves tissue taken from other parts of the body, that is transplanted along with the associated blood vessels to the reconstruction site. The vessels of the flap are usually anastomosed to the vessels of the neck (microvascular reconstruction) and the transplanted tissue thereby obtains a blood supply at its new location. Head and neck cancer patients are usually reconstructed using the free fibular flap, the latissimus dorsi flap, the radial forearm flap or the anterolateral thigh flap.

The combination of complicated surgery and often malnourished patients with a low body mass index (BMI), that typically suffer from tobacco and alcohol abuse, commonly lead to postoperative ICU treatment and complications. The most common are infections, re-operations, delayed wound healing and refeeding syndrome, which is reported in up to 35% of patients undergoing major surgery for head and neck cancer.

Even with successful reconstruction, many patients suffer from drooling, lack of adequate clenching, permanent gastric tube feeding, insufficient wound healing and a high recurrence rate. Enhanced recovery after surgery (ERAS) is a peri- and postoperative care concept designed to accelerate recovery and improve convalescence. It has previously been established as superior to conventional care for a wide variety of procedures. As one of the first departments in the world our department has successfully implemented an ERAS program for microsurgical patients that undergo breast reconstruction using autologous tissue. By utilizing our experience with ERAS and combining it with a review of our own patient data we have developed an ERAS protocol for microvascular reconstruction after ablative surgery for head and neck cancer.

Tipo di studio

Osservativo

Iscrizione (Anticipato)

25

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • København Ø
      • Copenhagen, København Ø, Danimarca, 2100
        • Reclutamento
        • Copenhagen University Hospital, Rigshospitalet
        • Contatto:
        • Contatto:
          • Christian T Bonde, MD, PhD
          • Numero di telefono: +45 35458701
          • Email: bonde@rh.dk

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

N/A

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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%.

Descrizione

Inclusion Criteria:

  • Patients eligible for ablative surgery for head and neck cancer with primary microvascular reconstruction.

Exclusion Criteria:

  • Patients with conditions leading to increased risk of thromboembolic events
  • Patients pre-operatively admitted to the ICU

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
ERAS Group
Prospectively included patients after introduction of an ERAS programme
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.
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.
Altri nomi:
  • Focus on nutritional status

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.

Focus on avoidance of over-hydration. Aim for fluid-load after surgery: max: +1000-1500 ml
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.
Altri nomi:
  • Chirurgia mininvasiva
Introduction of a number of functional discharge criteria to avoid prolonged postoperative hospitalisation
Control group
We retrospectively evaluated our procedures for the period 2014-2016
Non-formalised historical peri- and postoperative regimen.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Length of stay (LOS)
Lasso di tempo: 1 to 4 weeks
Time from surgery to discharge
1 to 4 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
ICU LOS
Lasso di tempo: 1-2 days
Time spent in the ICU (intensive care unit) post-operatively
1-2 days
Time to ambulation
Lasso di tempo: 1-7 days
Days from surgery until full ambulation (walking)
1-7 days
Incidence of infections
Lasso di tempo: 30 days
Number of postoperative infections
30 days
Incidence of re-operations
Lasso di tempo: 30 days
Number of return-to-theatre events
30 days
Complication-rate
Lasso di tempo: 30 days
Number of surgical related complications
30 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Jens H Hojvig, Md, Rigshospitalet, Denmark

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 giugno 2019

Completamento primario (Anticipato)

31 gennaio 2021

Completamento dello studio (Anticipato)

31 marzo 2021

Date di iscrizione allo studio

Primo inviato

11 marzo 2020

Primo inviato che soddisfa i criteri di controllo qualità

11 marzo 2020

Primo Inserito (Effettivo)

16 marzo 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 marzo 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 marzo 2020

Ultimo verificato

1 marzo 2020

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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