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Institutional Review Board Approval (institutional + review_board_approval)
Selected AbstractsInstitutional Review Board Approval for Clinical Application of New Medical Devices Rather Than Government AgencyARTIFICIAL ORGANS, Issue 12 2004Ph.D. Emeritus Editor in Chief, Yukihiko Nosé M.D. No abstract is available for this article. [source] Cervical epidural analgesia via a thoracic approach using nerve-stimulation guidance in adult patients undergoing total shoulder replacement surgeryACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 2 2007B. C. H. Tsui Background:, Continuous cervical epidural anesthesia can provide excellent peri- and post-operative analgesia, although several factors prevent its widespread use. Advancing catheters from thoracic levels to the cervical region may circumvent these barriers, provided they are accurately positioned. We hypothesize that guiding catheters from thoracic to cervical regions using low-current epidural stimulation will have a high success rate and enable excellent analgesia in adults undergoing total shoulder arthroplasty. Methods:, After Institutional Review Board approval, adult patients were studied consecutively. A 17-G Tuohy needle was inserted into the thoracic epidural space using a right paramedian approach with loss of resistance. A 20-G styletted epidural catheter, with an attached nerve stimulator, was primed with saline and a 1,10 mA current was applied as it advanced in a cephalad direction towards the cervical spine. Muscle twitch responses were observed and post-operative X-ray confirmed final placement. After a test dose, an infusion (2,8 ml/h) of ropivacaine 2 mg/ml and morphine 0.05 mg/ml (or equivalent) was initiated. Verbal analog pain scale scores were collected over 72 h. Results:, Cervical epidural anesthesia was performed on 10 patients. Average current required to elicit a motor response was 4.8 ± 2.0mA. Post-operative X-ray of catheter positions confirmed all catheter tips reached the desired region (C4,7). The technical success rate for catheter placement was 100% and excellent pain control was achieved. Catheters were positioned two to the left, four to the right and four to the midline. Conclusion:, This epidural technique provided highly effective post-operative analgesia in a patient group that traditionally experiences severe post-operative pain and can benefit from early mobilization. [source] Sacral nerve stimulation for voiding dysfunction: One institution's 11-year experience,NEUROUROLOGY AND URODYNAMICS, Issue 1 2007Suzette E. Sutherland Abstract Aim The purpose of this study was to review our institution's 11-year experience with SNS for the treatment of refractory voiding dysfunction. Dating back to 1993, it covers a span of time which describes the evolution of SNS as it includes PNE trials, non-tined (bone-anchored or fascial-anchored) leads, percutaneous tined leads with two-staged procedures, and even percutaneous pudendal trials. Methods A retrospective review was performed on SNS patients who received an implantable pulse generator (IPG) in our practice from 12/1993 to 12/2004. After Institutional Review Board approval, consents for chart review were obtained from 104 patients, representing 44% of this neuromodulatory patient population. Results Of our population, 87% were female and 13% were male. Average age at implant was 50 years,±,13.4 years. Duration of symptoms before implantation was 116 months (range 9,600 months). Eighty percent were implanted for a predominant complaint of urinary urgency and frequency (U/F). Overall, 22% had U/F only, 38% had concomitant urge incontinence (UI), and 20% had concomitant mixed incontinence (MI). Twenty percent were treated for non-obstructive urinary retention (UR), with half of these associated with a neurogenic etiology. Additionally, 46.2% had pelvic pain, 58.6% had bowel complaints, and 51% reported sexual dysfunction. In patients with U/F, mean voiding parameters as described by pre-implant voiding diaries revealed the following: 12.4 (±5.1) voids per 24 hr; 2.3 (±1.8) voids per night; 5.0 (±4.7) leaks per 24 hr; and 2.3 (±2.6) pads per 24 hr. Statistically significant improvements post-implantation were noted with mean decreases in the following: 4.3 voids per 24 hr; 1.0 void per night; 4.4 leaks per 24 hr; and 2.3 pads per 24 hr (all P,<,0.05). In the UR group a statistically significant improvement post-implantation was noted only in voids per night, with a mean decrease of 0.8 (P,<,0.05). With a mean follow up of 22 months (range 3,162 months), sustained subjective improvement was >50%, >80%, and >90% in 69%, 50%, and 35% of patients, respectively. By quality of life survey, 60.5% of patients were satisfied and 16.1% were dissatisfied with current urinary symptoms. Only 13% (14 patients) abandoned therapy, making up a significant portion of those dissatisfied with current urinary symptoms. Good overall lead durability was seen (mean 22 months, range 1,121 months), with the first successful lead proving to be the most durable (mean 28 months, range 1.4,120 months). Lead durability decreased progressively with subsequent trials. Overall, 53% of patients experienced at least one reportable event (RE) attributable to either lead or IPG. A total of 126 REs were noted, with 97% mild-to-moderate in severity. REs included lack of efficacy, loss of efficacy, infection, hematoma/seroma, migration, pain, undesirable change in sensation, and device malfunction. In this population, 47.1% of leads were tined while 52.9% were non-tined. Tined leads had an overall lower RE rate as compared to non-tined leads: 28% and 73%, respectively. Conclusions SNS is an effective method for treating certain types of voiding dysfunction. Although 53% of patients experienced at least one RE, 97% were mild-to-moderate and did not appear to affect the continued use of this therapy. With improved technology, such as percutaneous tined leads, the RE rate is decreasing. Further analyses of subsets of this population are currently underway. Neurourol. Urodynam. © 2006 Wiley-Liss, Inc. [source] Intraoperative reported adverse events in childrenPEDIATRIC ANESTHESIA, Issue 8 2009ATHINA KAKAVOULI MD Summary Background:, Significant intraprocedural adverse events (AE) are reported in children who receive anesthesia for procedures outside the Operating Rooms (NORA). No study, so far, has characterized AE in children who receive anesthesia in the operating rooms (ORA) and NORA when anesthesia care is provided by the same team in a consistent manner. Objective/Aim:, We used the same patient-specific Quality Assurance questionnaires (QAs), to elucidate incidences of intraoperative reported AE for children receiving anesthesia in NORA and ORA locations. Through multivariate logistic regression analysis, we assessed the association between patient's AE risk and procedure's location while adjusting for American Society of Anesthesiologists (ASA) status, age, and unscheduled nature of the procedure. Methods/Materials:, After Institutional Review Board approval, we used returned QAs of patients under 21 years, who received anesthesia from our pediatric anesthesia faculty from May 1 2006 through September 30, 2007. We analyzed QA data on: service location, unscheduled/scheduled procedure, age, ASA status, presence, and type of AE. We excluded QAs with incomplete information on date, location, age, and ASA status. Results:, We included 8707 cases, with 3.5% incidence of reported AE. We had 1898 NORA and 6808 ORA cases with AE incidence of 2.5% and 3.7%, respectively. Multivariate regression analysis revealed that patients with higher ASA status or younger age had higher incidence of reported AE, irrespective of location or unscheduled nature of the procedure. The most common AE type, for both sites, was respiratory related (1.9%). Conclusions:, Pediatric reported AE incidence was comparable for NORA and ORA locations. Younger age or higher ASA status are associated with increased risk of AE. [source] Pentobarbital vs chloral hydrate for sedation of children undergoing MRI: efficacy and recovery characteristicsPEDIATRIC ANESTHESIA, Issue 7 2004Shobha Malviya MD Summary Background :,Chloral hydrate (CH) sedation for magnetic resonance imaging (MRI) is associated with significant failure rates, adverse events and delayed recovery. Pentobarbital (PB), reportedly produces successful sedation in 98% of children undergoing diagnostic imaging. This study compared the efficacy, adverse events and recovery characteristics of CH vs PB in children undergoing MRI. Methods :,With Institutional Review Board approval and written consent, children were randomly assigned to receive intravenous (i.v.) PB (maximum 5 mg·kg,1 in incremental doses) or oral CH (75 mg·kg,1) prior to MRI. Sedation was augmented with 0.05 mg·kg,1 doses of i.v. midazolam (maximum 0.1 mg·kg,1) as necessary. Adverse effects, including hypoxaemia, failed sedation, paradoxical reactions and behavioural changes, the return of baseline activity, and parental satisfaction were documented. The quality of MRI scans was evaluated by a radiologist blinded to the sedation technique. Results :,PB facilitated an earlier onset of sedation (P = 0.001), higher sedation scores (P = 0.01), and less need for supplemental midazolam compared with CH. Severe hypoxaemia occurred in two children (6%) in the PB group. Fourteen per cent of the PB group experienced a paradoxical reaction, 9% sedation failure and 11% major motion artefact, compared with 0% (P = 0.05), 3 and 2% (P = NS), respectively, in the CH group. CH and PB were both associated with a high incidence of motor imbalance, and agitation. However, children who received PB had a slower return to baseline activity (P = 0.04). Conclusions :,Although PB facilitated a quicker sedation onset and reduced the requirement for supplemental sedation, it produced a higher incidence of paradoxical reaction and prolonged recovery with a similar failure rate compared with CH. [source] Paradoxical Vocal Fold Motion: A Sensory-Motor Laryngeal Disorder,THE LARYNGOSCOPE, Issue 2 2008Sabrina Cukier-Blaj SLP Abstract Objectives: The purpose of this study is to determine the laryngeal sensitivity (LS) thresholds and the ratings of laryngopharyngeal reflux symptoms in patients with paradoxical vocal fold motion (PVFM). Methods: This is a chart review following Institutional Review Board approval of 75 patients from January 2006 to June 2007. The patients were diagnosed with PVFM following case history, transnasal flexible laryngoscopy and spirometric testing. The data analyzed consisted of the reflux symptom index (RSI) and laryngopharyngeal sensitivity (LS). Laryngeal sensitivity and RSI were graded according to mild, moderate, or severe. Results: There were 12 (16%) patients with normal RSI scores, 37 patients (49.3%) with moderate RSI (RSI 11,22), and 26 patients (34.7%) with severe RSI (RSI >22). The right LS was normal in 11 patients (14.7%), moderately impaired in 16 patients (21.3%), and severely impaired in 48 (64%) patients. The left LS showed normal sensation in 11 patients (14.7%), moderately impaired LS in 13 patients (17.3%), and severe impairment in 51 patients (68%). Only one patient had both normal sensation and normal RSI, and 70.4% of patients had abnormal RSI and sensation thresholds. Conclusions: Patients diagnosed with PVFM had a high prevalence of symptoms related to LPR and markedly reduced LS. These findings suggest that PVFM may be triggered by reduced peripheral sensation or laryngeal inflammation. [source] Centrifugal Pump Support for Distal Aortic Perfusion During Repair of Traumatic Thoracic Aortic InjuryARTIFICIAL ORGANS, Issue 11 2002Joseph T. Walls Abstract: Paraplegia from ischemic injury of the spinal cord and renal failure from inadequate perfusion of the kidneys may occur from aortic cross-clamping during repair of traumatic thoracic aortic injuries. After Institutional Review Board approval, we retrospectively reviewed the charts of 26 patients surgically treated for traumatic transection of the descending thoracic aorta during a 14 year period (1987,2001), using centrifugal pump (Sarns) support for distal aortic perfusion. The study group comprised 19 males and 7 females, whose ages ranged from 15 to 69 years. For all but 1 patient, who fell from a flagpole, the injuries were incurred in motor vehicle accidents. Aortic cross-clamp time lasted between 5 to 78 min (median = 40 min). Mean arterial pressure ranged from 50 to 80 mm Hg (median = 70 mm Hg). All patients survived operation without developing paraplegia or renal failure. Distal centrifugal pump perfusion during repair of traumatic injury of the descending thoracic aorta is a valuable adjunct during surgical treatment and aids in preservation of spinal cord and renal function. [source] Rater and occasion impacts on the reliability of pre-admission assessmentsMEDICAL EDUCATION, Issue 12 2009Rick D Axelson Context, Some medical schools have recently replaced the medical school pre-admission interview (MSPI) with the multiple mini-interview (MMI), which utilises objective structured clinical examination (OSCE)-style measurement techniques. Their motivation for doing so stems from the superior reliabilities obtained with the OSCE-style measures. Other institutions, however, are hesitant to embrace the MMI format because of the time and costs involved in restructuring recruitment and admission procedures. Objectives, To shed light on the aetiology of the MMI's increased reliability and to explore the potential of an alternative, lower-cost interview format, this study examined the relative contributions of two facets (raters, occasions) to interview score reliability. Methods, Institutional review board approval was obtained to conduct a study of all students who completed one or more MSPIs at a large Midwestern medical college during 2003,2007. Within this dataset, we identified 168 applicants who were interviewed twice in consecutive years and thus provided the requisite data for generalisability (G) and decision (D) studies examining these issues. Results, Increasing the number of interview occasions contributed much more to score reliability than did increasing the number of raters. Conclusions, Replicating a number of interviews, each with one rater, is likely to be superior to the often recommended panel interview approach and may offer a practical, low-cost method for enhancing MSPI reliability. Whether such a method will ultimately enhance MSPI validity warrants further investigation. [source] Effectiveness of Adenoidectomy and Laser Tympanic Membrane Fenestration,THE LARYNGOSCOPE, Issue 2 2001Steven P. Cook MD Abstract Objective Adenoidectomy alone or with tonsillectomy (A±T) is an effective surgical intervention in the management of otitis media in children, especially when it is performed in conjunction with insertion of pressure equalization tubes (PETs). Otorrhea and persistent tympanic membrane (TM) perforation are frequent complications. This study evaluates the effectiveness of intermediate duration middle ear ventilation using laser tympanic membrane fenestration (LTMF) without tube insertion and as an adjunct to adenoidectomy in resolving middle ear disease within the first 90 days after surgery. Study Design This pilot study was a multicenter, prospective clinical cohort trial. Institutional review board approval and informed consent were obtained. The study involved four tertiary care pediatric otolaryngology departments. Fifty children (96 ears) were treated with LTMF in conjunction with A±T from June 1, 1998, through March 30, 1999. Ages ranged from 9 months to 12 years. Patients undergoing A±T who would have been recommended for PET insertion instead underwent middle ear ventilation with LTMF using the OtoLAMÔ device (ESC/Sharplan, Yokneam, Israel). Patients were seen at 30, 60, and 90 days postoperatively. Resolution of otitis media with effusion was determined by clinical examination, which included pneumatic otoscopy, audiometry, and tympanometry. Results Of the treated ears, 88%, 86%, and 83% had clinical resolution of middle ear disease at 30, 60, and 90 days, respectively. Preoperatively, 45% (n = 85) of ears had normal hearing; 92% (n = 49) had normal hearing at 90 days. Eighty-nine percent (n = 92) had type C2 or B tympanograms preoperatively, and 12% (n = 60) had type C2 or B at 90 days. Conclusion Laser tympanic membrane fenestration in conjunction with adenoidectomy was effective in restoring normal middle ear function at 90 days post-treatment in greater than 80% of children who otherwise may have had placement of PETs. [source] Does the Emergency Exception from Informed Consent Process Protect Research Subjects?ACADEMIC EMERGENCY MEDICINE, Issue 11 2005Nicole M. Delorio MD Abstract Although subject protection is the cornerstone of medical ethics, when considered in the context of research using emergency exception from informed consent, its success is debatable. The participants of a breakout session at the 2005 Academic Emergency Medicine Consensus Conference discussed the issues surrounding subject protection and advanced the following recommendations. 1) There are no outcome measures that define "protection"; therefore, it is not currently known whether or not subjects are protected under the current rules. 2) Care must be taken to protect not only the individual from harm during research but also to protect society from unregulated research in other countries and an inability to appropriately advance medical knowledge. 3) Some surrogate markers/methods of protection whose efficacies are debatable include data safety monitoring board activity, the community consultation and public notification (CC/PN) process, and institutional review board approval. 4) Minimal-risk studies should be held to different standards of protection than those that involve more significant risk to the subject. 5) A handful of studies have been published regarding community consultation and notification, and the majority are case studies. Those that are specifically designed to discover the most successful methods are hindered by a lack of formal outcomes measures and tend to have negative results. 6) Follow-up data from the CC/PN process should be disclosed to the Food and Drug Administration and incorporated into study designs. 7) Focus groups and/or random-digit dialing have been suggested as promising methods for fulfilling the CC/PN requirements. 8) Studies need to be funded and performed that formally investigate the best means of CC/PN. 9) More funding for this research should be a priority in the emergency medicine and critical care communities. More data regarding terminated studies should be made available to the research community. 10) Quantifiable markers of success for CC/PN must be validated so that research may determine the most successful methods. 11) Data regarding subjects' and family members' experiences with exception from informed consent studies need to be obtained. [source] Complete hypopharyngeal obstruction by mucosal adhesions: A complication of intensive chemoradiation for advanced head and neck cancerHEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 8 2006Elizabeth J. Franzmann MD Abstract Background. Severe swallowing dysfunction is the dominant long-term complication observed in patients treated for head and neck squamous cell carcinoma (HNSCC) with treatment protocols using intensive concurrent chemotherapy with radiation therapy (chemo/XRT). We identified a subset of these patients, who were seen with complete obstruction of the hypopharynx distal to the site of the primary cancer, and in whom we postulate that the obstruction was caused by separable mucosal adhesions rather than obliteration by a mature fibrous stricture. Methods. Seven patients were referred to the senior author with a diagnosis of complete hypopharyngeal obstruction between 1992 and 2001. The diagnosis was confirmed by barium swallow imaging and/or endoscopy before referral in all patients. Patients underwent recanalization by passing a Jesberg esophagoscope under general anesthesia, followed by serial dilations and intensive swallowing therapy. Patient charts were reviewed retrospectively after institutional review board approval. Results. All seven patients were successfully recanalized. No patient had a perforation or other significant complication related to the recanalization procedure or subsequent dilations. Five of the seven patients showed improvement in swallowing at some point after the initial procedure, but just two patients recovered sufficiently to have their gastrostomy tube removed permanently. Conclusions. We conclude that complete hypopharyngeal obstruction secondary to mucosal adhesions is one cause of gastrostomy tube dependence in patients who have been treated with chemo/XRT for HNSCC. It is a difficult problem to treat, but most patients can recover useful swallowing function without undergoing laryngectomy or major surgical reconstruction. The postulated pathophysiology has implications for prevention as well as treatment. © 2006 Wiley Periodicals, Inc. Head Neck, 2006 [source] Increased volume of coverage for abdominal contrast-enhanced MR angiography with two-dimensional autocalibrating parallel imaging: Initial experience at 3.0 TeslaJOURNAL OF MAGNETIC RESONANCE IMAGING, Issue 5 2009Darren P. Lum MD Abstract Purpose: To assess the feasibility and the quality of abdominal three-dimensional (3D) contrast enhanced MR angiograms acquired at 3.0 Tesla (T) using a new 2D-accelerated autocalibrating parallel reconstruction method for Cartesian sampling (2D-ARC). Materials and Methods: With institutional review board approval and written informed consent, a prospective trial in 6 normal healthy volunteers and 23 patients referred for evaluation of suspected renovascular disease was performed. The volunteers underwent abdominal MRA with and without 2D-ARC acceleration. Images were evaluated independently by two blinded vascular radiologists in randomized order. Vessel conspicuity was rated on a five-point scale. Evaluation for significant differences between the scores for each technique was performed using a Wilcoxon signed-rank test. Results: In the series of six volunteers, no statistical significance was found between the image quality scores for 2D-ARC accelerated and nonaccelerated exams. A high proportion of the 23 clinical 2D-ARC exams were graded as diagnostic (vessel conspicuity score ,2; Reader 1, 96%; Reader 2, 100%) for overall image quality. Conclusion: Subjective image quality of 2D-ARC accelerated MRA was equivalent to the conventional MRA method. However, the 2D-ARC accelerated sequence provided a 3.5-fold increase in imaging volume, complete abdominal coverage, and a 30% reduction in voxel volume, all within the same acquisition time. J. Magn. Reson. Imaging 2009;30:1093,1100. © 2009 Wiley-Liss, Inc. [source] Muscle biopsy substantiates long-term MRI alterations one year after a single dose of botulinum toxin injected into the lateral gastrocnemius muscle of healthy volunteers,MOVEMENT DISORDERS, Issue 10 2009A. Sebastian Schroeder MD Abstract Despite numerous clinical and experimental studies on botulinum toxin type A (BoNT/A), long-term alterations of muscle texture and fine structure following BoNT/A treatment have thus far not been studied in normal human skeletal muscle. After obtaining institutional review board approval, we performed a prospective, placebo-controlled, double-blinded follow-up study on two healthy adults using magnetic resonance imaging (MRI) and muscle biopsy to visualize long-term alterations after a single BoNT/A injection into the lateral head of the gastrocnemius muscle. MRI disclosed a high-signal-intensity pattern in short tau inversion recovery sequences, and a reduction of the cross-sectional area in the BoNT/A-injected, but not in the saline-injected contralateral control muscle (at 6 to 9 months in volunteer A: 73%, in B: 62%; at 12 months in A: 88%, and in B: 78%). Enzyme histochemistry, 12 months after injection, confirmed neurogenic atrophy of muscle fibers only in the BoNT/A-injected muscle. Electron microscopy revealed additional degenerative changes at the neuromuscular junction. The data confirm that MRI is a suitable tool to monitor the long-term effect of BoNT/A on skeletal muscle. Neurogenic muscle atrophy following a single BoNT/A injection should be taken into consideration when repeated BoNT/A injections into the same muscles are proposed. © 2009 Movement Disorder Society [source] Follow-Up Recommendations for Benign Breast BiopsiesTHE BREAST JOURNAL, Issue 5 2006Susanna Shin MD Abstract: Histologically proven benign breast disease increases a woman's relative risk for subsequent cancer development. Yet follow-up guidelines for mammogram and clinical breast examination after a benign breast biopsy are lacking. Our objective was to determine if increased surveillance is indicated following a benign breast biopsy. Following institutional review board approval, a retrospective database review was conducted of prospectively gathered patients who had a benign breast biopsy (core or excisional) for an abnormality detected on mammogram, ultrasound, or clinical breast examination. Follow-up, for all subjects, was a clinical breast examination and mammogram or ultrasound at 6 months, 1 year, and 2 years after benign breast biopsy by a breast surgeon. End points were the need for additional biopsies or cancer detection. Statistical analysis was performed using chi-squared analysis. From January 2000 to July 2003, 156 patients age 18,86 years had a benign breast biopsy. During the 2 year follow-up, 20 patients (13%) required a subsequent biopsy. No significant difference was observed in mean age, race, menarche, menopause, parity, age at first live birth, use of oral contraceptives, history of prior biopsy, or the pathology of the initial lesion between those who needed a subsequent biopsy and those who did not. Seven excisional biopsies were performed (one at 6 months, four at 1 year, and two at 2 years follow-up) for growth of the benign breast biopsy lesion, and pathology remained concordant with the original diagnosis. Thirteen biopsies were done for new findings on mammogram or ultrasound. Three of these (1.9%) yielded a cancer diagnosis (one at 6 months, one at 1 year, and one at 2 years follow-up). No new lesions were identified on follow-up by clinical breast examination alone. Increased surveillance following a benign breast biopsy is necessary because of the increased need for subsequent biopsy or risk of cancer development. This should include imaging (mammography or ultrasound) and a clinical breast examination 6 months, 1 year, and 2 years after a benign breast biopsy. [source] Preparation Techniques for the Injection of Human Autologous Cartilage: An Ex Vivo Feasibility Study,THE LARYNGOSCOPE, Issue 1 2008J Pieter Noordzij MD Abstract Objectives: To determine the optimum donor site and preparation technique for injecting human autologous cartilage as a potentially permanent implant material for vocal fold medialization. Study Design: Prospective ex vivo experimental model. Methods: Human nasal septal and auricular cartilage was obtained from eight surgical cases after institutional review board approval. The auricle and nasal septum were chosen as potential donor sites because of ease of accessibility, volume of cartilage potentially available, and minimal subsequent cosmetic deformity after the tissue harvesting procedure. Various preparation techniques readily available in most operating rooms were tested for their efficacy in generating an injectable cartilage slurry. The various cartilage slurries were injected through sequentially smaller needles and examined cytologically. Results: The best injection properties for both nasal septal and auricular cartilage were obtained by drilling the cartilage down with a 5 mm otologic cutting bur, which allowed free passage through an 18 gauge needle. Cytologic examination of drilled septal cartilage showed good uniformity of cartilage pieces with a mean largest dimension of 0.44 ± 0.33 mm, and 33% of lacunae contained viable-appearing chondrocytes. Cytologic examination of drilled auricular cartilage was similar, exceptonly 10% of lacunae were occupied by chondrocytes. Other techniques tested (knife, morselizer, and cartilage crusher) did not yield injectable cartilage slurries. Conclusions: Both nasal septal and auricular cartilage can be prepared for injection via an 18 gauge needle using a cutting otologic bur. Further testing of in vivo viability and long-term volume retention is needed. [source] Advanced-stage renal cell carcinoma treated by radical nephrectomy and adjacent organ or structure resectionBJU INTERNATIONAL, Issue 2 2009Michael E. Karellas OBJECTIVE To examine the effect of radical nephrectomy (RN) with adjacent organ and structure resection on survival, as invasion of adjacent organs in patients with renal cell carcinoma (RCC) is rare. PATIENTS AND METHODS After institutional review board approval, we reviewed our database and statistically analysed of patients with pathological stage T3 or T4 RCC who had RN and resection of a contiguous organ or structure. RESULTS We identified 38 patients of 2464 (1.5%) who had RN with adjacent organ or structure resection. The median (interquartile range) size of the mass was 11 (8,14) cm, and the follow-up 13 (5,33) months. Most patients (68%) were pT4 stage and had conventional clear cell carcinoma (95%). Fourteen patients (37%) had positive surgical margins. The liver (10) was the most commonly resected adjacent organ or structure. Only one patient remains alive with no evidence of disease at 5 years, while three are currently alive with disease. Overall, 34 of 38 patients (90%) ultimately died from disease at a median (range) of 11.7 (5.4,29.2) months after surgical resection. The surgical margin status was the only statistically significant factor for recurrence and death (P = 0.006). CONCLUSIONS The prognosis for patients with advanced RCC and adjacent organ or structure involvement is extremely poor and similar to that of patients with metastatic disease. These patients should be thoroughly counselled about the impact of surgical management and considered for entry into neoadjuvant or adjuvant clinical trials with new targeted systemic agents. [source] | ||||||||||