Clinical trial · Observational
Optimising Microsurgical Reconstruction After Advanced Head and Neck Cancers
Optimising Microsurgical Reconstruction After Advanced Head and Neck Cancers - Enhanced Recovery and Improved Clinical Pathway
NCT04308525CI-TRIAL-00044205unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAD/CAM system for reconstructive plates | Procedure | — | UNRESOLVED |
| Early ambulation | Behavioral | — | UNRESOLVED |
| Early oral feeding | Behavioral | — | UNRESOLVED |
| Functional discharge criteria | Other | — | UNRESOLVED |
| Goal-directed fluid therapy | Procedure | — | UNRESOLVED |
| Multimodal opioid-sparing analgesia | Other | — | UNRESOLVED |
| Standard/historical postoperative regimen | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- ERAS Group
- description
- Prospectively included patients after introduction of an ERAS programme
- interventionNames
- Behavioral: Early ambulation
- Behavioral: Early oral feeding
- Other: Multimodal opioid-sparing analgesia
- Procedure: Goal-directed fluid therapy
- Procedure: CAD/CAM system for reconstructive plates
- Other: Functional discharge criteria
- label
- Control group
- description
- We retrospectively evaluated our procedures for the period 2014-2016
- interventionNames
- Other: Standard/historical postoperative regimen
Primary outcomes (1)
- measure
- Length of stay (LOS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (8)
- BACKGROUNDHanasono 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 19373778
- BACKGROUNDMontero 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 25979396
- BACKGROUNDBak 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 20036611
- BACKGROUNDWei 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 3523559
- BACKGROUNDOmura 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 24682763
- BACKGROUNDRasmussen 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 27682582
- BACKGROUNDKehlet 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 9175983
- BACKGROUNDBonde 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.