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Optimising Microsurgical Reconstruction After Advanced Head and Neck Cancers

2020年3月21日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (予想される)

25

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • København Ø
      • Copenhagen、København Ø、デンマーク、2100
        • 募集
        • Copenhagen University Hospital, Rigshospitalet
        • コンタクト:
        • コンタクト:
          • Christian T Bonde, MD, PhD
          • 電話番号:+45 35458701
          • メール:bonde@rh.dk

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

なし

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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%.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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.
他の名前:
  • 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.
他の名前:
  • 低侵襲手術
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Length of stay (LOS)
時間枠:1 to 4 weeks
Time from surgery to discharge
1 to 4 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
ICU LOS
時間枠:1-2 days
Time spent in the ICU (intensive care unit) post-operatively
1-2 days
Time to ambulation
時間枠:1-7 days
Days from surgery until full ambulation (walking)
1-7 days
Incidence of infections
時間枠:30 days
Number of postoperative infections
30 days
Incidence of re-operations
時間枠:30 days
Number of return-to-theatre events
30 days
Complication-rate
時間枠:30 days
Number of surgical related complications
30 days

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Jens H Hojvig, Md、Rigshospitalet, Denmark

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2019年6月1日

一次修了 (予想される)

2021年1月31日

研究の完了 (予想される)

2021年3月31日

試験登録日

最初に提出

2020年3月11日

QC基準を満たした最初の提出物

2020年3月11日

最初の投稿 (実際)

2020年3月16日

学習記録の更新

投稿された最後の更新 (実際)

2020年3月24日

QC基準を満たした最後の更新が送信されました

2020年3月21日

最終確認日

2020年3月1日

詳しくは

本研究に関する用語

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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