A phase 3 active-controlled trial of liposomal bupivacaine via sciatic nerve block in the popliteal fossa after bunionectomy.

STUDY OBJECTIVE: To investigate the efficacy, safety, pharmacodynamics, and pharmacokinetics of liposomal bupivacaine (LB) administered via ultrasound-guided sciatic nerve block in the popliteal fossa in participants undergoing bunionectomy. DESIGN: Two-part, randomized, double-blind, active-controlled trial (NCT05157841). SETTING: Operating room, postanesthesia care unit, and health care facility (6 sites). PATIENTS: Adults with American Society of Anesthesiologists physical status classification ≤3 and body mass index ≥18 to <40 kg/m2 undergoing elective distal metaphyseal osteotomy. INTERVENTIONS: Part A participants were randomized 1:1:1 to LB 266 mg, LB 133 mg, or bupivacaine hydrochloride 50 mg (BUPI). Part B participants were randomized 1:1 to LB (at the dose established by part A) or BUPI. MEASUREMENTS: The primary endpoint was area under the curve (AUC) of numerical rating scale (NRS) pain intensity scores 0-96 h after surgery. Secondary endpoints included total postsurgical opioid consumption, opioid-free status 0-96 h after surgery, and pharmacokinetic endpoints. MAIN RESULTS: Part A enrolled 22 participants per group. In part B, additional participants were randomized to LB 133 mg (n = 59) and BUPI (n = 60) (185 total). LB 133 mg had significant reductions versus BUPI in the AUC of NRS pain intensity score (least squares mean [LSM], 207.4 vs 371.4; P < 0.00001) and total opioid consumption 0-96 h after surgery (LSM, 17.7 [95% confidence interval (CI), 13.7, 22.8] morphine milligram equivalents [MMEs] vs 45.3 [95% CI, 35.1, 58.5] MMEs; P < 0.00001) and an increased proportion of opioid-free participants (24.4% vs 6%; odds ratio, 5.04 [95% CI, 2.01, 12.62]; P = 0.0003) in parts A + B. Adverse events were similar across groups. CONCLUSIONS: LB 133 mg administered via sciatic nerve block in the popliteal fossa after bunionectomy demonstrated superior and long-lasting postsurgical pain control versus BUPI. The clinical relevance of these findings is supported by concurrent reductions in pain and opioid consumption over 4 days after surgery and a significantly greater percentage of participants remaining opioid-free.

Adolescent Gastric Banding: a 5-Year Longitudinal Study.

BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) is used to treat obesity in adults. Less is known about long-term results of the procedure in adolescents. OBJECTIVES: To evaluate LAGB 5-year outcomes in teenagers with severe obesity. SETTING: Children's hospital, USA. METHODS: Adolescents (14-18 years) underwent LAGB in an FDA-approved observational clinical trial. Outcomes including anthropometric measurements, comorbid conditions, complications, and band retention were collected through 60 months. RESULTS: One hundred thirty-seven subjects underwent LAGB (94 female, 43 male; 43% white, 37% Hispanic, 17% black; 4% other). Mean age and body mass index (BMI) pre-operatively were 17.0 + 1.2 years and 48.3 + 8.2 kg/m2, respectively. Comorbidities were present in 71%. Maximum weight loss occurred by 36 months (mean % excess weight loss (EWL) 40.6 + 35.2, mean % excess BMI loss (EBMIL) 41.6 + 34.9) and was maintained through 5 years for most subjects. There were no significant differences in weight loss by gender. Twenty-three (18%) of 127 adolescents reporting at 60 months achieved 50% excess weight loss. Postoperative heartburn and emesis occurred in 70% and 32%, respectively. Complications requiring additional surgery occurred 80 times in 63 patients. Thirty-three (26%) of 127 subjects contacted at 5 years had undergone band removal. CONCLUSION: In this study, fewer than 20% of adolescents with severe obesity lost > 50% of their excess weight following LAGB. Nearly 50% of patients required additional surgery. With reports of success following sleeve gastrectomy and gastric bypass, we believe that LAGB is not a preferred choice to treat adolescents with obesity.

Adolescent laparoscopic adjustable gastric banding (LAGB): prospective results in 137 patients followed for 3 years.

BACKGROUND: Evidence supports weight loss surgery as an effective long-term weight reduction therapy in adults. METHODS: Few adolescent obesity surgery series report outcomes for laparoscopic gastric banding (LAGB). We studied a population of morbidly obese teenagers who underwent LAGB to evaluate its safety and effectiveness in this age group. Three hundred and six morbidly obese adolescent candidates for LAGB were screened. Enrollees were evaluated monthly by the nutritionist and the surgical team to monitor compliance with recommended changes in diet and exercise. Patients also underwent psychiatric and endocrine evaluations. Those who made good changes in eating and exercise habits over a 6-month period were offered LAGB. The setting was a university hospital in the United States. RESULTS: One hundred thirty-seven adolescent patients underwent LAGB. The mean weight gain between enrollment and LAGB was 4.7 kg. Mean preoperative weight, body mass index (BMI), and excess BMI were 136.1 kg, 48.3 kg/m2, and 23.6 kg/m2, respectively. Mean BMI at 6, 12, 18, 24, and 36 months was 43.8, 41.6, 41.5, 40.5, and 39.3. Excess BMI loss was 28.4%, 35.9%, and 41.1% at 1, 2, and 3 years postop. Co-morbid conditions improved or resolved with weight loss after LAGB. Thirty patients (22%) underwent one or more additional operations for complications. Twenty-seven patients (20%) converted to other weight loss procedures or had their bands removed. CONCLUSION: LAGB is a safe weight loss operation in adolescents. Morbidly obese adolescents can lose weight successfully and experience health improvement following LAGB, but the role of LAGB in the younger population requires long-term evaluation.

Comparative outcomes of laparoscopic adjustable gastric banding in adolescents and adults.

BACKGROUND: Obesity is a major health problem in all age groups. Morbidly obese adolescents often fail to lose weight with diet and exercise and, as adults, become candidates for surgical intervention. METHODS: We matched adolescents (14-19 yr) and adults (19-73 yr) retrospectively from university medical center-based adolescent and adult obesity surgery programs who had undergone laparoscopic adjustable gastric banding by gender and body mass index (n = 115). RESULTS: The most common co-morbid condition in adolescents was menstrual irregularity/polycystic ovary syndrome. Hypertension was the most common co-morbid condition in adults. The adults were nearly 9 times as likely to be diabetic as the adolescents. We analyzed patients with ≥6 months of follow-up for the percentage of excess weight loss at 6-month intervals for ≤24 months. Both groups demonstrated progressive weight loss that did not differ significantly in the initial 12 months; however, the data beyond 12 months were limited by the small numbers. CONCLUSION: The presence of more serious co-morbidities in obese adults, coupled with the successful weight loss after laparoscopic adjustable gastric banding, in adolescents suggests that weight loss surgery might be indicated at a younger age for severely obese individuals.

Re-emergence of diabetes after gastric bypass in patients with mid- to long-term follow-up.

BACKGROUND: Studies have shown that type 2 diabetes (T2DM) improves or resolves shortly after Roux-en-Y gastric bypass (RYGB). Few data are available on T2DM recurrence or the effect of weight regain on T2DM status. METHODS: A review of 42 RYGB patients with T2DM and >or=3 years of follow-up and laboratory data was performed. Postoperative weight loss and T2DM status was assessed. Recurrence or worsening was defined as hemoglobin A1c >6.0% and fasting glucose >124 mg/dL and/or medication required after remission or improvement. Patients whose T2DM recurred or worsened were compared with those whose did not, and patients whose T2DM improved were compared with those whose T2DM resolved. RESULTS: T2DM had either resolved or improved in all patients (64% and 36%, respectively); 24% (10) recurred or worsened. The patients with recurrence or worsening had had a lower preoperative body mass index than those without recurrence or worsening (47.9 versus 52.9 kg/m2; P = .05), regained a greater percentage of their lost weight (37.7% versus 15.4%; P = .002), had a greater weight loss failure rate (63% versus 14%; P = .03), and had greater postoperative glucose levels (138 versus 102 mg/dL; P = .0002). Patients who required insulin or oral medication before RYGB were more likely to experience improvement rather than resolution (92% versus 8%, P

Outcomes of laparoscopic adjustable gastric banding in patients with low body mass index.

BACKGROUND: The current National Institutes of Health guidelines have recommended bariatric surgery for patients with a body mass index (BMI) >40 kg/m(2) or BMI >35 kg/m(2) with significant co-morbidities. However, some preliminary studies have shown that patients with a BMI that does not meet these criteria could also experience similar weight loss and the benefits associated with it. METHODS: An institutional review board-approved protocol was obtained to study the effectiveness of laparoscopic adjustable gastric banding in patients with a low BMI. A total of 66 patients with a BMI of 30-35 kg/m(2) and co-morbidities (n = 22) or a BMI of 35-40 kg/m(2) without co-morbidities (n = 44) underwent laparoscopic adjustable gastric banding. These patients were compared with 438 standard patients who had undergone laparoscopic adjustable gastric banding who met the National Institutes of Health criteria for bariatric surgery. The excess weight loss at 3, 6, 12, and 18 months and the status of their co-morbidities were compared between the 2 groups. RESULTS: The average BMI for the study group was 36.1 +/- 2.6 kg/m(2) compared with 46.0 +/- 7.3 kg/m(2) for the control group. Both groups had significant co-morbidities, including hypertension, diabetes, hyperlipidemia, arthritis, gastroesophageal reflux disease, stress incontinence, and obstructive sleep apnea. The mean percentage of excess weight loss was 20.3% +/- 9.0%, 28.5% +/- 14.0%, 44.7% +/- 19.3%, and 42.2% +/- 33.7% at 3, 6, 12, and 18 months, respectively. This was not significantly different from the excess weight loss in the control group, except for at 12 months. Both groups showed similar improvement of most co-morbidities. CONCLUSION: Moderately obese patients whose BMI is less than the current guidelines for bariatric surgery will have similar weight loss and associated benefits. Laparoscopic adjustable gastric banding is a safe and effective treatment for patients with a BMI of 30-35 kg/m(2).

Adjustable gastric banding as revisional bariatric procedure after failed gastric bypass--intermediate results.

BACKGROUND: Although gastric bypass is the most common bariatric procedure in the United States, it is has been associated with a failure rate of 15% (range 5-40%). The addition of an adjustable gastric band to Roux-en-Y gastric bypass has been reported to be a useful revision strategy in a small series of patients with inadequate weight loss after proximal gastric bypass. METHODS: We report on 22 patients who presented with inadequate weight loss or significant weight regain after proximal gastric bypass. All patients underwent revision with the placement of an adjustable silicone gastric band around the proximal gastric pouch. The bands were adjusted at 6 weeks postoperatively and beyond, as needed. Complications and weight loss at the most recent follow-up visit were evaluated. RESULTS: The mean age and body mass index at revision was 41.27 years (range 25-58) and 44.8 +/- 6.34 kg/m(2), respectively. Patients had experienced a loss of 19%, 27%, 47.3%, 42.3%, 43%, and 47% of their excess weight at 6, 12, 24, 36, 48, and 60 months after the revisional procedure, respectively. Three major complications occurred requiring reoperation. No band erosions have been documented. CONCLUSION: The results from this larger series of patients have also indicated that the addition of the adjustable silicone gastric band causes significant weight loss in patients with poor weight loss outcomes after gastric bypass. That no anastomosis or change in absorption is required makes this an attractive revisional strategy. As with all revisional procedures, the complication rates appear to be increased compared with a similar primary operation.

Frequency distribution of weight loss percentage after gastric bypass and adjustable gastric banding.

BACKGROUND: The results of surgical procedures for weight loss are often described in terms of the percentage of excess weight lost. Expressing outcomes using the mean and standard deviation might not adequately describe the clinical experience. This could in part be because the use of the mean +/- standard deviation assumes a normal or random distribution of outcomes. It has been our perception that the weight loss results after gastric bypass are relatively normally and tightly distributed around the mean, making it relatively predictable. However, we have found that the results after adjustable gastric banding are more highly variable. In fact, there appears to be 2 groups of patients after this restrictive operation. One group, that is able to work well and does not struggle much against the restriction, accepts the limits that it imposes, and another group, that does not easily learn to deal with the restriction and hence mal-adapts. METHODS: To evaluate the validity of our clinical perception, we undertook an analysis of the distribution of weight loss by the percentiles of excess weight lost. All patients with follow-up of > or =1 years after gastric bypass or adjustable banding were evaluated for this analysis. The demographics and percentage of excess weight loss were evaluated. The distribution of the percentage of excess weight loss in 10% increments was evaluated. RESULTS: Both groups were similar with respect to the mean patient age. However, the patients in the gastric bypass group had had a significantly greater mean preoperative body mass index and were more likely to be women. As expected, the weight loss of the gastric bypass patients fell in a normal single-peak distribution for < or =5 years of follow-up. The data from the adjustable gastric band patients at 1 year demonstrated a normal single-peak distribution, with a longer rightward tail. At 2 and 3 years postoperatively, the data from the band patients had a 2-peaked curve. CONCLUSION: The initial weight loss results after gastric banding are less predictable than those after gastric bypass. A similar analysis of long-term outcomes might be enlightening and assist in making clinical decisions.

Markers of bone and calcium metabolism following gastric bypass and laparoscopic adjustable gastric banding.

BACKGROUND: Several studies have suggested that morbid obesity is associated with vitamin D deficiency and elevated parathyroid hormone (PTH). Studies have also suggested that there is an increase in vitamin D deficiency, bone resorption, and elevated PTH after gastric bypass surgery. Few studies have evaluated markers of bone and calcium metabolism after laparoscopic adjustable gastric banding or compared these results to those after gastric bypass. METHODS: Data on all patients undergoing primary gastric bypass (GBP; n = 979) and laparoscopic adjustable gastric banding (LAGB; n = 269) procedures at a tertiary-referral center from June 1996 through March 2005 were reviewed from a prospective database. Only patients with 25OH vitamin D levels available were included in this study (n = 534; GBP = 403, LAGB = 131). All patients were advised to take at least 1,200 mg calcium and 800-1,200 IU of vitamin D daily before and subsequent to their operation. Markers for bone metabolism [25OH Vitamin D, corrected serum calcium, alkaline phosphatase (AP), and PTH] were evaluated preoperatively and 3, 6, 12, and 24 months postoperatively. An analysis of variance and chi-square were performed to determine differences between the operative groups. Linear regression analysis was performed to evaluate the relationship between preoperative body mass index (BMI) and 25OH vitamin D and PTH levels and between percent excess weight loss and 25OH vitamin D and PTH after surgery. RESULTS: Sixty-four percent of all patients presented with vitamin D deficiency (<20 ng/ml) and 14% presented with elevated PTH preoperatively. Mean 25OH vitamin D levels and AP levels increased significantly after GBP surgery (vitamin D, 17 to 25 ng/ml 12 months post-op; AP, 80 to 90 IU/L 24 months post-op). Corrected calcium levels remained within normal limits and showed no change over time after both procedures. AP levels significantly increased from 76 IU/l preoperatively to 82 IU/l 6 months after LAGB surgery and then decreased to 59 IU/l 24 months after LAGB surgery. Linear regression analysis of preoperative vitamin D, PTH, and BMI values showed a significant positive relationship between initial BMI and PTH (r = 0.29) and a significant negative relationship between vitamin D and initial BMI (r = -0.19). A significant positive linear relationship between vitamin D and percent excess weight loss was evident 12 and 24 months after GBP surgery (r = 0.39 and 0.57, respectively). A negative relationship was evident between PTH and vitamin D 6 months after GBP surgery (r = -0.35) and 12 months after LAGB surgery (r = -0.61). CONCLUSIONS: These findings suggest that morbid obesity is associated with vitamin D deficiency, and elevated PTH and with adequate supplementation, GBP, and particularly LAGB, patients can improve their bone metabolism abnormalities related to obesity. Furthermore, adequate supplementation for GBP patients may attenuate the increased risk for bone loss associated with malabsorption from the bypass.

Neoadjuvant chemotherapy and radiation for patients with locally unresectable pancreatic adenocarcinoma: feasibility, efficacy, and survival.

BACKGROUND: We evaluated the feasibility and efficacy of neoadjuvant chemotherapy and radiation for patients with locally unresectable pancreatic cancer. MATERIALS AND METHODS: From October 2000 to August 2006, 245 patients with pancreatic adenocarcinoma underwent surgical exploration at our institution. Of these, 78 patients (32%) had undergone neoadjuvant therapy for initially unresectable disease, whereas the remaining patients (serving as the control group) were explored at presentation (n=167). All neoadjuvant patients received gemcitabine-based chemotherapy, often in conjunction with docetaxal and capecitabine in a regimen called GTX (81%). Seventy-five percent of neoadjuvant patients also received preoperative abdominal radiation (5,040 rad). RESULTS: Neoadjuvant patients were younger than control-group patients (60.8 vs 66.2 years, respectively, p<0.002). Seventy-six percent of neoadjuvant patients were resected as compared to 83% of control patients (NS). Concomitant vascular resection was required in 76% of neoadjuvant patients but only 20% of NS (p<0.01). Complications were more frequent in the neoadjuvant group (44.1 vs 30.9%, p<0.05), and mortality was higher (10.2 vs 2.9%, p<0.03). Among the neoadjuvant patients, all but one of the deaths were in patients that underwent arterial reconstruction. Mortality for patients undergoing a standard pancreatectomy without vascular resection was 0.8% in this series. Of patients resected, negative margins were achieved in 84.7% of neoadjuvant patients and 72.7% of NS. Within the cohort of neoadjuvant patients, radiation significantly increased the complication rate (13.3 vs 54.6%, p<0.006), but did not affect median survival (512 vs 729 days, NS). Median survival for patients who received neoadjuvant therapy (503 days) was longer than NS that were found to be unresectable at surgery (192 days, p<0.001) and equivalent to NS that were resected (498 days). CONCLUSIONS: Resection rate, margin status, and median survivals were equivalent when neoadjuvant patients were compared to patients considered resectable by traditional criteria, demonstrating equal efficacy. Surgical resection with venous reconstruction following neoadjuvant therapy for patients with locally advanced pancreatic cancer can be performed with acceptable morbidity and mortality. This approach extended the boundaries of surgical resection and greatly increased median survival for the "inoperable" patient with advanced pancreatic cancer.

Prospective randomized trial of banded versus nonbanded gastric bypass for the super obese: early results.

BACKGROUND: Banded gastric bypass has been reported to result in superior weight loss compared with standard nonbanded gastric bypass. However, an adequate comparison of these procedures has not yet been reported. METHODS: A total of 90 patients were enrolled in this prospective randomized double-blind trial comparing banded and nonbanded open gastric bypass for the treatment of super obesity. The banding technique involved placement of a 1.5 x 5.5-cm polypropylene band around the proximal gastric pouch of a standard gastric bypass procedure using the technique of Capella. Chi-square testing and analysis of variance were performed to find any differences in patient characteristics (gender, age, and initial body mass index), percentage of excess weight lost at 6, 12, 24, and 36 months postoperatively, improvement or resolution of co-morbidities, and complications in the banded versus nonbanded gastric bypass groups. RESULTS: As expected, no differences were present in the patient characteristics or incidence of co-morbidities between the banded (n = 46) and nonbanded (n = 44) groups. The body mass index, percentage of women, and mean age was 59.5 and 56.5 kg/m2, 64% and 73.8% (P = .09), and 40.6 +/- 7.4 and 42.6 +/- 7.2 years for the banded and nonbanded groups, respectively; all differences were nonsignificant. No significant differences were found in the resolution of co-morbidities. No significant difference was present in the percentage of excess weight loss at 6, 12, and 24 months (43.1% versus 24.7%, 64.0% versus 57.4%, and 64.2% versus 57.2%, respectively) postoperatively; however, the banded patients had achieved a significantly greater percentage of excess weight loss at 36 months (73.4% versus 57.7%; P <.05). The incidence of intolerance to meat and bread was greater in the banded patients. The overall number of complications was 12 (26%) in the banded and 13 (29.5%) in the nonbanded group, a nonsignficant difference. No band erosions had occurred at the last follow-up visit, and no patients in either group died. CONCLUSION: These results suggest that although the initial weight loss was not significantly different between the 2 groups, the banded patients continued to lose weight for < or = 3 years. The polypropylene band appeared to be well tolerated. We plan longer follow-up to confirm the possibility of additional weight loss and the prevention of weight regain in the banded group, as well as to document any long-term band complications.

Thyroidectomy using monitored local or conventional general anesthesia: an analysis of outpatient surgery, outcome and cost in 1,194 consecutive cases.

BACKGROUND: Critical appraisal of safety, feasibility, and economic impact of thyroidectomy procedures using local (LA) or general anesthesia (GA) is performed. METHODS: Consecutive patients undergoing thyroidectomy procedures were selected from a prospective database from January 1996 to June 2003 of a single-surgeon practice at a tertiary center. Statistical analyses determined differences in patient characteristics, outcomes, operative data, and length of stay (LOS) between groups. A cohort of consecutive patients treated in 2002-2003 by all endocrine surgeons at the institution was selected for cost analysis. RESULTS: A total of 1,194 patients underwent thyroidectomy, the majority using LA (n = 939) and outpatient surgery (65%). Female gender (76%), body mass index > or = 30 kg/m2 (29%), median age (49 years), and cancer diagnosis (45%) were similar between groups. Extent of thyroidectomy (59% total) and concomitant parathyroidectomy (13%) were similarly performed. GA was more commonly utilized for patients with comorbidity [15% vs. 10%, Anesthesia Society of America (ASA) > or = 3; P < 0.001], symptomatic goiter (13% vs. 7%; P = 0.004), reoperative cases (10% vs. 6%; P = 0.01), and concomitant lymphadenectomy procedures (15% vs. 3%; P < 0.001). GA was associated with significant increase in LOS > or = 24 hours (17 % vs. 4%) or overnight observation (49 % vs. 14%), P < 0.001. Operative room utilization was significantly associated with type of anesthesia (180 min vs. 120 min, GA vs. LA, P < .001) and impacted to a lesser degree by surgeon operative time (89 minutes vs. 76 minutes, GA vs. LA; P = .089). Overall morbidity rates were similar between groups (GA 5.8 % vs. LA 3.2%). The actual total cost (ATC) per case for GA was 48% higher than for LA and 30% higher than the ATC for all procedures (P = 0.006), with the combined weighted average impacted by more LA cases (n = 217 vs. 85). CONCLUSION: These data from a large, unselected group of thyroidectomy patients suggest LA results in similar outcomes and morbidity rates to GA. It is likely that associated LA costs are lower.

Adjustable gastric banding as a revisional bariatric procedure after failed gastric bypass.

BACKGROUND: Inadequate weight loss after proximal gastric bypass presents a clinical challenge to bariatric surgeons. Pouch size, stoma size and limb length are the variables that can be surgically altered. Aside from conversion to distal bypass, which may have significant negative nutritional sequelae, revisional surgery for this group of patients has not often been reported. The addition of adjustable silicone gastric banding (ASGB) to Roux-en-Y gastric bypass (RYGBP) may be a useful revision strategy because it has potential safety benefits over other revisional approaches. MATERIALS AND METHODS: We report on 8 patients who presented with inadequate weight loss or significant weight regain after proximal gastric bypass. All patients underwent revision with the placement of an ASGB around the proximal gastric pouch. Bands were adjusted at 6 weeks postoperatively and beyond as needed. Complications and weight loss at the most recent follow-up visit were evaluated. RESULTS: Mean age and body mass index (BMI) at the time of revision were 39 +/- 9.9 years and 44.0 +/- 4.5 kg/m2 respectively. No patients were lost to follow-up, and they lost an average of 38.1 +/- 10.4% and 44.0 +/- 36.3% of excess weight and 49.1 +/- 20.9% and 52.0 +/- 46.0% of excess BMI in 12 and 24 months respectively. Patients lost an average of 62.0 +/- 20.5% of excess weight from the combined surgeries in 67 (48-84) months. The only complication was the development of a seroma overlying the area of the port adjustment in one patient. There have been no erosions or band slippages to date. CONCLUSIONS: These results indicate that the addition of an ASGB causes significant weight loss in patients with poor weight loss outcome after RYGBP. The fact that no anastomosis or change in absorption is required may make this an attractive revisional strategy. Long- term evaluation in a larger population is warranted.

Thyroidectomy using local anesthesia: a report of 1,025 cases over 16 years.

BACKGROUND: Thyroid surgery is performed using general anesthesia by the majority of surgeons in current practice. This study was conducted to analyze the utility and safety of local anesthesia for thyroid surgery. STUDY DESIGN: Prospective data were collected for 1,025 consecutive patients undergoing thyroidectomy using monitored local anesthesia during a 16-year period by a single surgeon at a tertiary referral center. Patient features, operative data, length of stay, and complications are reported with multivariate analysis for factors associated with outcomes. RESULTS: A total of 1,025 patients underwent local thyroidectomy procedures; 34 required conversion to general anesthesia (3.3%). Total thyroidectomy (n = 589), lobectomy (n = 391), or subtotal and partial resections (n = 45) were performed for benign (n = 402), suspicious (n = 154), or malignant (n = 463) conditions. Local anesthesia was successful for thyroidectomy with concomitant parathyroidectomy (n = 142) or lymphadenectomy (n = 27), extensive goiter (n = 102), and reoperative neck procedures (n = 59). The majority of patients (90%) were considered low to intermediate risk (American Society of Anesthesiologists score /= 3). With accumulating experience, local anesthesia was applied more broadly to high-risk (p < 0.001), older (p = 0.04), or obese patients (p = 0.04), and likewise used in more extensive goiter resections (p = 0.05) and bilateral procedures (p < 0.001). Patients experienced temporary (n = 20) and permanent (n = 10) recurrent laryngeal nerve injuries, hematoma (n = 5), permanent hypocalcemia (n = 1), emergent tracheostomy (n = 1), wound infection (n = 1), and myocardial infarction (n = 1). Outpatient procedures (96%) substantially increased with maturation of the local anesthesia program (p < 0.001). Length of stay > 24 hours was associated with patient comorbidity (p < 0.001, relative risk 3.25). CONCLUSIONS: Thyroidectomy using local anesthesia appears safe and applicable to a wide range of patients, including those who pose a general anesthetic risk or require more complex procedures, when performed by an experienced surgeon.

The impact of sestamibi scanning on the outcome of parathyroid surgery.

Although sestamibi scanning has been shown to have greater sensitivity and specificity than other preoperative localization techniques for parathyroid adenoma, it is unclear whether preoperative scanning improves outcomes for parathyroid surgery. Data from 528 consecutive patients who underwent neck exploration for primary hyperparathyroidism by one surgeon were collected prospectively over a 5-yr period. Patients were classified by preoperative scanning status (no scan, positive scan, and negative scan), and outcomes were compared in terms of operative time, length of hospital stay, and cure rate. Patients who had undergone a previous parathyroid operation and patients who received alternate preoperative localization techniques (ultrasound, magnetic resonance imaging, and computed tomography) were excluded from the study. All scans were ordered by the referring physician-the surgeon made no recommendations for preoperative scanning. All groups were similar in terms of gender, age, anesthesia class, body habitus, and complication rate. There was no significant difference in cure rate between patients who had preoperative scanning (97.5%) vs. those who did not (99.3%); however, there was a significant difference in cure rate between the negative-scan group (92.7%) and the positive and no-scan groups (99.3%, P < 0.01). In patients without concomitant thyroid surgery, there was no significant difference in operative time between the no scan (42.4 +/- 14.9 min) vs. the all-scan group (40.2 +/- 15.2 min); however, there was a significant difference between the negative scan group (44.5 +/- 21.9 min) and the positive scan group (38.5 +/- 12.6 min, P < 0.01). There was no significant difference in length of hospital stay among the three groups. These results suggest that, although preoperative sestamibi scanning does not alter the outcome of parathyroid surgery, it does identify those patients who are less likely to be cured.