Optimising Microsurgical Reconstruction After Advanced Head and Neck Cancers
1 other identifier
observational
25
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2019
CompletedFirst Submitted
Initial submission to the registry
March 11, 2020
CompletedFirst Posted
Study publicly available on registry
March 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedMarch 24, 2020
March 1, 2020
1.7 years
March 11, 2020
March 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of stay (LOS)
Time from surgery to discharge
1 to 4 weeks
Secondary Outcomes (5)
ICU LOS
1-2 days
Time to ambulation
1-7 days
Incidence of infections
30 days
Incidence of re-operations
30 days
Complication-rate
30 days
Study Arms (2)
ERAS Group
Prospectively included patients after introduction of an ERAS programme
Control group
We retrospectively evaluated our procedures for the period 2014-2016
Interventions
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.
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.
Introduction of a number of functional discharge criteria to avoid prolonged postoperative hospitalisation
Non-formalised historical peri- and postoperative regimen.
Eligibility Criteria
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%.
You may qualify if:
- Patients eligible for ablative surgery for head and neck cancer with primary microvascular reconstruction.
You may not qualify if:
- Patients with conditions leading to increased risk of thromboembolic events
- Patients pre-operatively admitted to the ICU
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Copenhagen University Hospital, Rigshospitalet
Copenhagen, København Ø, 2100, Denmark
Related Publications (8)
Hanasono MM, Friel MT, Klem C, Hsu PW, Robb GL, Weber RS, Roberts DB, Chang DW. Impact of reconstructive microsurgery in patients with advanced oral cavity cancers. Head Neck. 2009 Oct;31(10):1289-96. doi: 10.1002/hed.21100.
PMID: 19373778BACKGROUNDMontero PH, Patel SG. Cancer of the oral cavity. Surg Oncol Clin N Am. 2015 Jul;24(3):491-508. doi: 10.1016/j.soc.2015.03.006. Epub 2015 Apr 15.
PMID: 25979396BACKGROUNDBak M, Jacobson AS, Buchbinder D, Urken ML. Contemporary reconstruction of the mandible. Oral Oncol. 2010 Feb;46(2):71-6. doi: 10.1016/j.oraloncology.2009.11.006. Epub 2009 Dec 29.
PMID: 20036611BACKGROUNDWei FC, Chen HC, Chuang CC, Noordhoff MS. Fibular osteoseptocutaneous flap: anatomic study and clinical application. Plast Reconstr Surg. 1986 Aug;78(2):191-200. doi: 10.1097/00006534-198608000-00008.
PMID: 3523559BACKGROUNDOmura K. Current status of oral cancer treatment strategies: surgical treatments for oral squamous cell carcinoma. Int J Clin Oncol. 2014;19(3):423-30. doi: 10.1007/s10147-014-0689-z. Epub 2014 Apr 1.
PMID: 24682763BACKGROUNDRasmussen SO, Kristensen MB, Wessel I, Andersen JR. Incidence and Risk Factors of Refeeding Syndrome in Head and Neck Cancer Patients-An Observational Study. Nutr Cancer. 2016 Nov-Dec;68(8):1320-1329. doi: 10.1080/01635581.2016.1225103. Epub 2016 Sep 28.
PMID: 27682582BACKGROUNDKehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606.
PMID: 9175983BACKGROUNDBonde CT, Khorasani H, Elberg J, Kehlet H. Perioperative Optimization of Autologous Breast Reconstruction. Plast Reconstr Surg. 2016 Feb;137(2):411-414. doi: 10.1097/01.prs.0000475749.40838.85.
PMID: 26818274BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jens H Hojvig, Md
Rigshospitalet, Denmark
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Ph.D.-student
Study Record Dates
First Submitted
March 11, 2020
First Posted
March 16, 2020
Study Start
June 1, 2019
Primary Completion
January 31, 2021
Study Completion
March 31, 2021
Last Updated
March 24, 2020
Record last verified: 2020-03