The 33 reference contexts in paper F. Carta, A. Figus, N. Chuchueva, D. Quartu, G. Sambiagio B., R. Loche F., C. Gerosa, R. Puxeddu, Ф. Карта, А. Фигус, H. Чучуева, Д. Кварту, Дж. Самбьяджо Б., Р. Локе Ф., К. Джероза, Р. Пукседу (2018) “Влияние интенсивной терапии на исходы и частоту осложнений после реконструктивных операций в области головы и шеи // The effect of admission to intensive care unit on outcomes and complication rates after head and neck reconstruction” / spz:neicon:ogsh:y:2018:i:3:p:61-71

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    Влияние интенсивной терапии на исходы и частоту осложнений после реконструктивных операций в области головы и шеи. Опухоли головы и шеи 2018;8(3):61–71. Introduction Nowadays, microvascular free flap reconstruction is an essential step in the treatment of head and neck malignancies
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    because it offers the opportunity to perform an oncologic sound surgical resection associated with the immediate repair of complex 3-dimensional structures, improving patients’ quality of life and survival [2].
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    Introduction Nowadays, microvascular free flap reconstruction is an essential step in the treatment of head and neck malignancies [1] because it offers the opportunity to perform an oncologic sound surgical resection associated with the immediate repair of complex 3-dimensional structures, improving patients’ quality of life and survival
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    [2]
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    . Although patients may suffer from general surgical complications such as bleeding and/or infection, free flap failure, due to irreversible arterial or venous thrombosis, is one of the most important complications to be avoided.
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    Close monitoring has been demonstrated successful in reducing these complications but, whether Intensive Care Unit (ICU) must be considered as an integral part of the postoperative management of the patients undergoing head and neck free flap reconstruction or not, it is still unclear
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    . The present study analysed the selection criteria and the outcomes of all consecutive patients undergoing ablative surgery followed by microvascular reconstruction for head and neck malignancies in our centre.
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    for free flap reconstruction during the primary treatment for head and neck malignancies at early and advanced stages, or after recurrent disease or inadequate reconstructions performed in other Centres. Previous chemotherapy and/or radiotherapy were not exclusion criteria alone, but were correlated with age and comorbidities, according to the Age Adjusted Charlson Comorbidity Index (AACCI)
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    . Fragile elderly patients with AACCI >5, were generally submitted to simpler reconstructive procedures with pedicled flaps. Preoperative histologic diagnosis was obtained in all patients with head and neck lesions.
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    Preoperative histologic diagnosis was obtained in all patients with head and neck lesions. All patients were restaged according to the 8th edition of the Union for International Cancer Control – American Joint Committee on Cancer TNM staging system
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    . Patients with head and neck malignancy underwent wide radical excision of the primary tumour with ipsilateral or bilateral neck dissection (according to the site of the tumour and the risk for nodal involvement) followed by free flap reconstruction.
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    In case of doubtful flap survival, the surgeon was promptly called to evaluate the situation as to go back to theatre for exploration and flap salvage. Outcome parameters included length of hospital stay and complications. According to E. M. Genden et al.
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    and the Clavien–Dindo system [7], complications were divided into surgical donor-site and flap complications (requiring surgical re-exploration) or non-surgical donor-site and flap complications managed with medical therapy.
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    In case of doubtful flap survival, the surgeon was promptly called to evaluate the situation as to go back to theatre for exploration and flap salvage. Outcome parameters included length of hospital stay and complications. According to E. M. Genden et al. [6] and the Clavien–Dindo system
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    [7]
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    , complications were divided into surgical donor-site and flap complications (requiring surgical re-exploration) or non-surgical donor-site and flap complications managed with medical therapy. According to E.
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    Clavien–Dindo system [7], complications were divided into surgical donor-site and flap complications (requiring surgical re-exploration) or non-surgical donor-site and flap complications managed with medical therapy. According to E. O. Dimovska et al., complications were also divided in early and late complications, when observed within and after the first 30 postoperative days respectively
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    [8]
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    . Donor-site complications include seroma, haematoma, infection, dehiscence, venous congestion and skin loss. Flap complications include partial or total flap failure, cervical hematoma, surgical site infection, wound dehiscence, fistula.
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    Postoperative arrhythmia, myocardial infarction, pulmonary oedema, postoperative hypertension, deep vein thrombosis, pulmonary embolism, acute renal failure, respiratory failure, pneumonia and sepsis are classified as systemic complications. Adjuvant therapy was planned for advanced T stage (pT3 or pT4), multiple positive nodes, and/or per neural/lymphatic/vascular invasion
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    [9]
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    . All patients were addressed for regular follow-up according to the American Head and Neck Society guidelines [10] (mean time of 3.4 years, median time of 1.8 years, range of 6 months – 7 years). A disease-free state was defined as the absence of cancer demonstrated by head and neck surgeon and imaging, and (if necessary) pathological examination following biopsy, while the definition of dise
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    Adjuvant therapy was planned for advanced T stage (pT3 or pT4), multiple positive nodes, and/or per neural/lymphatic/vascular invasion [9]. All patients were addressed for regular follow-up according to the American Head and Neck Society guidelines
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    [10]
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    (mean time of 3.4 years, median time of 1.8 years, range of 6 months – 7 years). A disease-free state was defined as the absence of cancer demonstrated by head and neck surgeon and imaging, and (if necessary) pathological examination following biopsy, while the definition of disease state was referred to the presence of a local, regional or loco/regional relapse and/or distant metastases.
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    A disease-free state was defined as the absence of cancer demonstrated by head and neck surgeon and imaging, and (if necessary) pathological examination following biopsy, while the definition of disease state was referred to the presence of a local, regional or loco/regional relapse and/or distant metastases. Comorbidities were categorized retrospectively using the AACCI
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    [4]
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    . In the present study one of the goals was to compare complications and outcomes between elderly (≥65 years) vs young (<65 years) patients, between patients with AACCI ≤5 vs patients with AACCI >5, and between patients admitted in ICU during the early postoperative period vs patients treated only in the ward after surgery.
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    There is still a debate as to which venous system (cephalic or comitantes veins) should be anastomosed, but we found the anastomosis of the cephalic vein only was reliable in 71.6 % of the cases (n = 78). This finding confirms the recent experience of S. Razzano et al.
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    . Adequate venous out-flow must be assured to guarantee the survival of free flaps. In literature a dual venous anastomosis has been related with lower failure rate Table 3. Patients’ distribution according to stages of head and neck squamous cell carcinomas (by 8 th edition of the American Joint Committee on Cancer TNM staging system, n = 135) Таблица 3.
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    AACCI – индекс коморбидности Чарлсона с поправкой на возраст. (in the 1.51 % vs 5.03 % after single anastomosis), lower venous thrombosis rate (2.74 % vs 4.54 %), and lower revision rate (11.87 % vs 6.04 %)
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    . In our series 75.7 % patients (n = 109) received a single venous anastomosis. In the present series, the number of the anastomosis did not influence the outcomes. Although flap failures (n = 3) were observed in patients with a single venous anastomosis, these occurred during the early period of our experience, and statistical analysis did not show any significant difference (p = 0.447).
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    pedicle geometry, avoid the use of vein grafts, preserve potential recipient veins for future free flaps, make surgery technically simpler by using a single proximal large confluent vein rather than two distal smaller venae comitantes minimizing the risk for low blood velocity. According to literature, the recipient veins were generally identified among the internal jugular vein system
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    [13]
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    . Venous anastomosis is one of the most challenging technical aspects of microsurgery, but it can be improved by the use of an anastomotic coupler device. It is quicker and more reliable in maintaining the anastomotic site patent and it could be used also as end-to-side technique on the internal jugular vein (2 cases in our series).
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    II100.0SE 0Univariate analysis Pharynx and larynx (n = 6) Глотка и гортань (n = 6) III–IV62.5SE 21.960.0SE 21.962.5SE 21.3 Face (n = 7) Лицо (n = 7) All Все 100.0 SE 0 88.9 SE 10.5 72.9 SE 16.5 All the series Всего 72.4 SE 4.9 60.6 SE 5.1 67.5 SE 4.9 Note. SE – standard error. Примечание. SE – стандартная ошибка. although we are aware of possibility of forearm advancement-rotation flaps
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    [14]
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    . Two patients required a revision of the donor site defect with a further skin graft. Microsurgical vascularised osteo-myocutaneous free flaps are very useful for reconstruction of complex defects following maxillectomy and mandibulectomy [15, 16].
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    Two patients required a revision of the donor site defect with a further skin graft. Microsurgical vascularised osteo-myocutaneous free flaps are very useful for reconstruction of complex defects following maxillectomy and mandibulectomy
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    [15, 16]
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    . Both iliac crest and fibula free flaps can be considered the best option for mandibular reconstruction [15, 16]. We preferred the use of the vascularized iliac crest flap. There are no significant differences in terms of morbidity of the donor site between iliac crest and fibula free flaps patients [17].
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    Microsurgical vascularised osteo-myocutaneous free flaps are very useful for reconstruction of complex defects following maxillectomy and mandibulectomy [15, 16]. Both iliac crest and fibula free flaps can be considered the best option for mandibular reconstruction
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    [15, 16]
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    . We preferred the use of the vascularized iliac crest flap. There are no significant differences in terms of morbidity of the donor site between iliac crest and fibula free flaps patients [17]. All patients of the present series experienced pain at the donor site, which lasted for a mean time of 1.7 months; nevertheless, a follow-up of more than 6 months showed no residual donor site morbi
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    Both iliac crest and fibula free flaps can be considered the best option for mandibular reconstruction [15, 16]. We preferred the use of the vascularized iliac crest flap. There are no significant differences in terms of morbidity of the donor site between iliac crest and fibula free flaps patients
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    [17]
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    . All patients of the present series experienced pain at the donor site, which lasted for a mean time of 1.7 months; nevertheless, a follow-up of more than 6 months showed no residual donor site morbidities.
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    or distant metastases in total or subtotal glossectomy and despite we did not performed a quality of life assessment, the patients reconstructed with a vertical rectus abdominis muscle flap referred an improvement in the quality of life following reconstruction. Functional rehabilitation remains difficult but the use of the myocutaneous free flap has been demonstrated to deliver good outcomes
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    [18]
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    . In our series, the vertical rectus abdominis muscle flap was fixed anteriorly to the mandible and posteriorly to the base of tongue. The downfall of the larynx was avoided with the suspension of the hyoid bone to the mandible with non-absorbable suture.
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    The nasogastric feeding tube was routinely preferred for the supportive feeding since it was temporary and without potential mortality and morbidity as reported for percutaneous endoscopic gastrostomy
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    [19]
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    . Reconstructive failure almost doubles the patient’s length of stay, and is strongly associated with in-hospital mortality, since it can result in exposure of the great vessels or skull base, or the development of a pharyngo-cutaneous fistula [20].
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    Reconstructive failure almost doubles the patient’s length of stay, and is strongly associated with in-hospital mortality, since it can result in exposure of the great vessels or skull base, or the development of a pharyngo-cutaneous fistula
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    [20]
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    . In our series, we observed 40 (27.8 %) postoperative complications, including 3 (2.1 %) flap failures. B. H. Haughey et al. reported a 57 % rate of medical complication and a 29 % of flap complications, including a 4 % rate of complete flap failure [20].
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    In our series, we observed 40 (27.8 %) postoperative complications, including 3 (2.1 %) flap failures. B. H. Haughey et al. reported a 57 % rate of medical complication and a 29 % of flap complications, including a 4 % rate of complete flap failure
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    [20]
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    . Our patients who experienced free flap failure had a statistically significant longer hospitalization time (p <0.005) compared with the mean hospitalisation time of the whole cohort of patients (54.8 days vs 23.9 days respectively).
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    Our patients who experienced free flap failure had a statistically significant longer hospitalization time (p <0.005) compared with the mean hospitalisation time of the whole cohort of patients (54.8 days vs 23.9 days respectively). The role of anticoagulants is controversial, and includes aspirin, low-molecular-weight dextran, and subcutaneous heparin
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    [22, 23]
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    . Despite the increased risks of hematoma related to all the antithrombotic medicaments (most of all the aspirin) and the absence of general consensus on their efficacy in failure prevention, the morbidity represented by the loss of a free flap leaded us to systematically treat our patients with a daily dose of low-weight subcutaneous heparin and this protocol, that is also used for deep vein
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    to all the antithrombotic medicaments (most of all the aspirin) and the absence of general consensus on their efficacy in failure prevention, the morbidity represented by the loss of a free flap leaded us to systematically treat our patients with a daily dose of low-weight subcutaneous heparin and this protocol, that is also used for deep vein thrombosis prevention, appeared to be reliable
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    [21, 22]
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    . There are still no evidence-based guidelines for the prevention of microvascular thrombosis in the head and neck [21, 22]. Therefore, microsurgeons must evaluate carefully the clinical features of all flaps, since early detection of thrombosis is of primary importance and the chance of surgical salvage is lower after the first 48 hours of ischemia [23], as a consequence, flap monitoring shou
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    failure prevention, the morbidity represented by the loss of a free flap leaded us to systematically treat our patients with a daily dose of low-weight subcutaneous heparin and this protocol, that is also used for deep vein thrombosis prevention, appeared to be reliable [21, 22]. There are still no evidence-based guidelines for the prevention of microvascular thrombosis in the head and neck
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    [21, 22]
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    . Therefore, microsurgeons must evaluate carefully the clinical features of all flaps, since early detection of thrombosis is of primary importance and the chance of surgical salvage is lower after the first 48 hours of ischemia [23], as a consequence, flap monitoring should be compulsory during the first 48 postoperative hours, and clinical monitoring four times daily should be sufficient th
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    Therefore, microsurgeons must evaluate carefully the clinical features of all flaps, since early detection of thrombosis is of primary importance and the chance of surgical salvage is lower after the first 48 hours of ischemia
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    [23]
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    , as a consequence, flap monitoring should be compulsory during the first 48 postoperative hours, and clinical monitoring four times daily should be sufficient thereafter. Among microvascular surgeons, postoperative monitoring regimens vary greatly, including close observation of the flap colour (used by 79.4 % of surgeons), Doppler signal (used by 79.4 % of surgeons), hourly “flap monitoring
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    monitoring regimens vary greatly, including close observation of the flap colour (used by 79.4 % of surgeons), Doppler signal (used by 79.4 % of surgeons), hourly “flap monitoring pin prick”, and bleeding rate (used by 67.6 % of surgeons), capillary refill (used by 61.8 % of surgeons), skin surface temperature (used by 11.8 % of surgeons), and implanted Doppler (used by 8.8 % of surgeons)
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    , but in our opinion, clinical observation remains the simplest method of identifying vascular compromise. In our series, we reported a percentage of surgical revision of the anastomosis of 5.5 % (8 out of 144) comparable to the data reported in literature (4.5–17.0 %) [1, 25].
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    of surgeons), skin surface temperature (used by 11.8 % of surgeons), and implanted Doppler (used by 8.8 % of surgeons) [24], but in our opinion, clinical observation remains the simplest method of identifying vascular compromise. In our series, we reported a percentage of surgical revision of the anastomosis of 5.5 % (8 out of 144) comparable to the data reported in literature (4.5–17.0 %)
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    [1, 25]
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    . Three patients of our microsurgical series experienced a flap failure (jejunum flap, iliac crest and forearm flap). In all cases the flap was replaced with a pectoralis major pedicled flap. Worldwide, a large number of patients undergoing microvascular free flap reconstruction are initially admitted to ICU on the premise of improved reconstructive outcomes.
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    Our results are in line with the most recent findings of the literature, confirming that protocol-driven non-ICUbased care can support successful reconstructive outcomes with comparable safety to ICU early admission routine
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    [26]
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    . Furthermore, avoiding ICU admission can reduce length of hospitalization and overall costs of care in both academic and community-based institutions. In literature age alone is not a reliable prognostic factor for predicting medical complications, but it should be related with general health status, since an American Society of Anesthesiologists score of 3 is a statistically significant pro
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    prognostic factor for predicting medical complications, but it should be related with general health status, since an American Society of Anesthesiologists score of 3 is a statistically significant prognostic factor for medical complications, and diabetes mellitus, advanced atherosclerosis or other cardiovascular diseases impair the quality of the vessel wall and wound healing in general
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    [27]
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    . By using the AACCI, the authors characterized the impact of age and comorbidity on postoperative outcomes, and we found a not statistically significant higher surgical complication rate in the elderly group (36.4 % of the elderly patients vs 25.2 % in younger patients; p = 0.171817), while we observed a significant higher morbidity rate in young patients with AACCI >5 (52.9 % vs 20.2 % in yo
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    patients with advanced squamous cell carcinoma of the facial skin experienced 5-year DSS, OS, and RFS rate of 100; 88.9 and 72.9 % respectively; these results show as free flaps reconstruction associated with a radical compartmental surgery allowed a positive curative in our series of patients (G. Almadori et al. reported 5-year DSS rate of 67.8 % in a series of 130 patients with oral cancer
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    , F. Bussu et al. reported a 5-year DSS rate of 82 % in their series of patients with advanced malignancy of the parotid area [29], and F. T. Hall et al. reported 5-year DSS rate of 67 % for patients with cancer of the larynx and 37 % for those with cancer of the hypopharynx [30]).
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    Almadori et al. reported 5-year DSS rate of 67.8 % in a series of 130 patients with oral cancer [28], F. Bussu et al. reported a 5-year DSS rate of 82 % in their series of patients with advanced malignancy of the parotid area
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    , and F. T. Hall et al. reported 5-year DSS rate of 67 % for patients with cancer of the larynx and 37 % for those with cancer of the hypopharynx [30]). Conclusion A precise preoperative evaluation tailored to each patient on the basis of the functional age is mandatory to select the best candidates for head and neck microsurgical reconstruction.
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    Bussu et al. reported a 5-year DSS rate of 82 % in their series of patients with advanced malignancy of the parotid area [29], and F. T. Hall et al. reported 5-year DSS rate of 67 % for patients with cancer of the larynx and 37 % for those with cancer of the hypopharynx
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    [30]
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    ). Conclusion A precise preoperative evaluation tailored to each patient on the basis of the functional age is mandatory to select the best candidates for head and neck microsurgical reconstruction.
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