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Abstract: The University of Washington Quality of Life (UW-QOL) questionnaire, created in 1993 to evaluate health related quality of life, has been widely used in English-speaking populations and translated and validated in other languages. The aim of the present study was to carefully translate and psychometrically validate the UW-QOL questionnaire in Greek. The revised version of the questionnaire was obtained by forward and backward translation of the original English version, according to internationally accepted guidelines. Validation was performed in 120 patients with head and neck cancer treated in a Greek Anticancer Institute in Athens, during their follow-up visits. Eligible patients completed the Greek version of the questionnaire and two other previously validated quality of life questionnaires (EORTC QLQ H&N35 and C-30). Related data and the patients' demographics were extracted from the patient's notes. Strong internal consistency (mean Cronbach α value of 0.83) was shown, with good construct validity. Statistically significant differences were noted between tumour staging and treatment modality and global quality of life. Strong correlation was shown between previously validated EORTC questionnaires and the translated UW-QOL questionnaire. In conclusion, the Greek version of the UW-QOL questionnaire appears to be culturally appropriate and psychometrically valid. [Copyright &y& Elsevier]

Purpose: To investigate gender and other possible factors affecting the frequency and severity of postoperative complications in head and neck cancer free flap reconstruction. Materials and Methods: A prospective longitudinal cohort study was conducted at the Greek Anticancer Institute, St. Savvas Hospital in head and neck cancer free flap reconstruction concerning postoperative complications. We documented the patients' demographic characteristics, social habits, and perioperative factors (ie, duration of general anesthesia), reconstructive techniques, neoadjuvant radiotherapy, and physical status. Initially, univariate statistical analysis was performed to confirm which predictor variables might influence the presence and severity of complications. Next, multivariate statistical analysis was performed using logistical regression and including the factors that were statistically significant on univariate analysis. Results: From 1999 to 2009, we assessed 95 patients who had undergone surgery for head and neck cancer. Of the 95 patients, 24 were women and 71 were men. The patient age range was 20 to 87 years (mean 52, median 55). A total of 55 complications occurred in 49 patients (51.57%). Of the 55 complications, 12 (12.63%) were of major severity, 21 (22.10%) of median severity, and 22 (23.15%) of low severity. The statistical analysis revealed that the factors associated with complications were preoperative radiotherapy, female gender, and operation time. The factors associated with severe complications were female gender and alcohol use. Conclusions: Multivariate analysis of the data revealed that the factor associated with an increased incidence of postoperative complications was preoperative radiotherapy. Moreover, the variable that remained statistically significant and correlated with an increased incidence and severity of free flap reconstruction complications was female gender. Identifying the etiology of these findings is an intriguing field for additional research. [Copyright &y& Elsevier]

Summary: Background: Publication bias (PB) diminishes the full distribution of research, distorts and discredits the scientific record, and thus compromises evidence-based practice. The objective of this study was to analyse published controlled trials with regard to PB in leading oral and maxillofacial surgery (OMS) journals. Methods: All controlled trials published in the International Journal of Oral and Maxillofacial Surgery, Journal of Cranio-Maxillofacial Surgery, Journal of Oral and Maxillofacial Surgery, and British Journal of Oral and Maxillofacial Surgery in 2008 were analysed for a primary outcome, country of authors, sample size, gender of the first author, funding source and location of the study. Results: Of 952 published articles, 53 controlled trials (5.7%) were identified. The OMS journals preferentially published controlled trials with a positive outcome (77.4%) and from high-income countries (73.6%). Single-centred trials (86.8%) with low sample size (n <100; 69.8%) were published more frequently. The majority of the first authors were male (75.5%). Funding source disclosure in most studies (73.6%). Conclusions: Our results suggest the possible existence of PB in the OMS literature. Hence, it should be borne in mind that the published articles may not be representative of all scientific works, especially when systematic reviews and meta-analyses are conducted or read. In the meantime, journals should establish measures to eliminate PB to uphold scientific integrity. However, this study was an observation based on the published articles. An analysis of all submitted manuscripts would provide more accurate estimates of PB. Ethical considerations on PB are also discussed. [Copyright &y& Elsevier]

Objectives: To review outcomes and complications of endoscope-assisted submandibular sialadenectomy (EASS) and to analyze this innovative technique with regard to ethical issues. Methods: We used a systematic review study design to identify clinical studies on EASS, published in English, French, German, and Thai. The last electronic search was conducted in September 2009. We checked the bibliographies of the identified articles, relevant local journals, and congress abstracts. Publications were further assessed and assigned their respective levels of evidence. We also investigated reporting on human subject protection, conflicts of interest, funding support, and commercial relationships. Results: Five case series reporting a total of 28 patients met the inclusion criteria. There was no need of recourse to open surgery. All of the authors claimed satisfactory cosmetic results. Complications were uncommon. However, no controlled trial was available, and outcome measures varied between studies. Human subject protection and funding sources were mentioned in only 2 articles. Commercial relationships and conflicts of interest could not be identified. Conclusions: All of the reports favor outcomes of EASS. However, their level of evidence is low, and the superiority of this procedure over the conventional surgery remains unknown. The success of this procedure should not be overemphasized in information for consent and mislead surgeons to begin it without adequate training and elaborate environment. The lack of ethical documentation creates a high degree of suspicion of the studies. [ABSTRACT FROM AUTHOR]

Patients with head and neck squamous cell carcinoma (HNSCC) are at considerable risk for death, with 5-year relative survival rates of approximately 60%. The profound multifaceted deficiencies in cell-mediated immunity that persist in most patients after treatment may be related to the high rates of treatment failure and second primary malignancies. Radiotherapy and chemoradiotherapy commonly have severe acute and long-term side effects on immune responses. The development of immunotherapies reflects growing awareness that certain immune system deficiencies specific to HNSCC and some other cancers may contribute to the poor long-termoutcomes. Systemic cell-mediated immunotherapy is intended to activate the entire immune system and mount a systemic and/or locoregional antitumor response. The delivery of cytokines, either by single cytokines, for example, interleukin-2, interleukin-12, interferon-?, interferon-a, or by a biologic mix of multiple cytokines, such as IRX-2, may result in tumor rejection and durable immune responses. Targeted immunotherapy makes use of monoclonal antibodies or vaccines. All immunotherapies for HNSCC except cetuximab remain investigational, but a number of agents whose efficacy and tolerability are promising have entered phase 2 or phase 3 development. [ABSTRACT FROM AUTHOR]

Purpose: The use of temporalis myofascial flap (TMF) as a pedicled flap in craniofacial reconstructive surgery is well established. The transposition of temporalis muscle results in a large hollowing of the temporal fossa that leaves the patient with a cosmetic impairment. Reconstruction of this donor site deformity is desirable. One of the established reconstructive techniques is the use of a prefabricated porous high-density polyethylene (HDPE) temporal implant. In order to evaluate results from its use, we retrospectively reviewed a series of 21 consecutive patients. Materials and Methods: From October 1999 to October 2004, 21 patients (7 men and 14 women) aged 32 to 85 years (mean, 65) had their surgical defects reconstructed with the use of a TMF. The majority of patients (15 of 21) had squamous cell carcinoma of the maxilla or the maxillary sinus. In 17 patients, the reconstructive procedure was performed simultaneously with the oncological resection, whereas in 4, a secondary reconstruction was performed. In 1 patient, bilateral TMFs were used to cover a total maxillectomy defect. Standard surgical approach was used in all patients during TMF elevation. The temporal defect was reconstructed with the use of a prefabricated sterile HDPE implant (Medpor; Porex Surgical Inc, College Park, GA). Fixation of the implant to the recipient infratemporal fossa was performed with black silk sutures (in 2 patients) or titanium miniscrews (in 19 patients). The manufacturer’s instructions for the placement of the implant were followed in all cases. One of the 21 operated patients preoperatively received radiotherapy (RT). Of the remaining 20 patients, 5 underwent postoperative RT. Results: Eighteen patients are alive and free from disease. One died during the perioperative period from myocardial infarction and 2 more from locoregional recurrence of their disease, 18 and 27 months postoperatively. In all 21 patients, the placement of the Medpor temporal implant was successful and no immediate or perioperative complications resulting from its use were encountered, giving an overall success implantation rate of 100%. Follow-up ranged from 9 to 70 months (mean, 39). The condition of the implant was evaluated with computed tomography in 18 of the 21 patients as part of the standard postoperative assessment. Radiographic results of the recipient site did not reveal any abnormalities. In 7 patients, the contour of the HDPE implant could be manually palpated, and in 3, it could be seen to protrude subcutaneously. Esthetic results were judged satisfactory from all patients. The hemicoronal skin flap healed uneventfully in all patients and did not cause a visible scar even to bald male patients. Conclusions: The reconstruction of the temporal defect after TMF transposition with the use of a Medpor temporal implant is an easy and safe method. The implant does not seem to cause any tissue reaction, and long-term functional and esthetic results are excellent. When properly used and the relevant manufacturers’ instructions are carefully followed, the success rate of the method is extremely high. [Copyright &y& Elsevier]

Purpose: Primary oral leiomyosarcomas are rare tumors. Information regarding the biological behavior, prognosis, and appropriate management of this neoplasm is lacking in the literature. The purpose of this report was to summarize the data of isolated case reports of primary oral leiomyosarcoma that have been published in the English literature during the past 25 years. The cases of 4 additional new patients who have been treated in our department during the past 10 years are also presented. Patients and Methods: The data for 46 patients obtained from 32 individual articles retrieved from the English literature were added to our 4 cases and produced a total number of 50 cases of primary leiomyosarcomas of the oral tissues. Patients were analyzed according to demographic data, anatomic location, type of treatment, and survival. Results: Primary oral leiomyosarcoma may affect any age with peaks of occurrence in the third, sixth, and seventh decades of life. There is no gender predilection. Female patients presented the higher incidence in the third decade, whereas males had an even age distribution. The tumor arises in approximately 70% of the cases in the maxillary and mandibular bones. Radical surgery was the treatment of choice. Radiotherapy and chemotherapy when applied in recurrent tumors had little effect. The most adverse prognostic factor was the positive surgical margins. The 5-year survival was 62% (62.9% for females and 52.6% for males, P > .1968). Conclusions: Cases of oral leiomyosarcoma appear to be associated with major neurovascular structures of the facial skeleton, as evidenced from the imaging studies of our 4 patients. Primary oral leiomyosarcoma is a rare tumor that should be managed with aggressive surgical resection in order to safeguard curability. Histopathologic diagnosis is greatly facilitated with positive immunohistochemical staining for smooth muscle antigenic markers. [Copyright &y& Elsevier]

Malignant tumors of the orbit and the orbitomaxillary region constitute 4-8% of head and neck malignancies. The lesions can be primary orbital malignant tumors or can invade the orbit from the eyelids, the eyeball or the paranasal sinuses, especially the maxillary sinus and ethmoids. The commonest primary malignant tumors of the orbit are lymphomas, rhabdomyosarcomas and lacrimal gland epithelial tumors. These tumors are excluded from the present study since their management differs from that of metastatic tumors. Our experience is based on a series of 48 patients operated during the last five years. There was an equal distribution according to both age and sex, with two-thirds of the patients being over 60 years of age. Histologically, the basal cell carcinomas (B.C.C.) prevailed with 19 cases, followed by squamous cell carcinomas (Sq.C.C.) in 12, adenocarcinomas (AdenoCa) in 10 and orbital melanomas (O.M.) in 7. In 13 cases the maxilla was also affected. Surgical treatment varied from exenteration to wide cran iofacial resections; immediate reconstruction followed in all cases. Only 10 patients were treated with surgery alone. In the remaining 38 patients radiotherapy was given, alone or in combination with chemotherapy. The surgical techniques included exente ration with split-thickness skin grafting in 19 cases, exenteration with coverage with median forehead flap in 16, and maxillectomy with forehead and temporalis flaps in 7 cases. The tumors recurred in 12 patients, all of them in the first postoperative year. Ten patients died from intracranial involvement or distant metastases. In six of these patients the lesions were Sq.C.C., in two AdenoCa and in two O.M. It is concluded that the surgical treatment of orbital and orbitomaxillary malignancies, although subject to broad guidelines that determine the operability of the tumors, should be individualized according to the extent of the lesion and the experience of the surgeon. [ABSTRACT FROM AUTHOR]