RESUMEN
BACKGROUND: Total knee arthroplasty (TKA) is performed on approximately 790,000 patients annually in the United States and is projected to increase to 1.5 million by 2050. This study aimed at assessing the use of preoperative cryoneurolysis on patients undergoing TKA by analyzing: (1) pain severity; (2) opioid use; (3) functional status; and (4) sleep disturbance (SD) over 6 months following discharge. METHODS: Patients enrolled in the Innovations in Genicular Outcomes Registry between September 2021 and February 2024 were followed for 6 months. Our analyses included patients undergoing unilateral primary TKA with no preoperative opioid prescription, who either received cryoneurolysis, or did not. Baseline patient demographics were collected before TKA and tabulated. Pain management was assessed via the Brief Pain Inventory-Short Form instrument for pain severity. SD was measured using the patient-reported outcomes measurement information system questionnaire. Each outcome measure was assessed prior to TKA, weekly, and at monthly follow-up. Data were analyzed by a generalized linear mixed-effect regression model to compare cryoneurolysis versus control patients, with a P < .05 as significant. RESULTS: There were 80 patients who were treated with preoperative cryoneurolysis, while 60 control patients did not have treatment. Patients receiving cryoneurolysis experienced significantly lower pain severity and SD over the 6-month follow-up than control patients (P = .046). Cryoneurolysis was also associated with a trend toward greater functional improvement that did not reach statistical significance (P = .061). Further, patients who underwent cryoneurolysis were 72% less likely than control group patients to take opioids over 6 months following discharge (P < .001). CONCLUSIONS: Preoperative cryoneurolysis therapy in opioid-naive patients undergoing TKA is associated with improved pain, decreased opioid use, and improved SD for 6 months postoperatively. Cryoneurolysis, a nonopioid pain relief modality administered preoperatively, demonstrated substantial benefits in patients who underwent TKA.
RESUMEN
BACKGROUND: Knee osteoarthritis (OA) affects 19% of American adults aged more than 45 years and costs $27+ billion annually. A wide range of nonoperative treatment options are available. This study compared 6 treatments: cryoneurolysis with deep genicular nerve block (Cryo-Deep/Both), cryoneurolysis with superficial nerve block (Cryo-Superficial), intra-articular hyaluronic acid (IA-HA) injections, nonsteroidal anti-inflammatory drug injections (IA-NSAIDs), IA-corticosteroids (IA-CS) injections, or IA-triamcinolone extended release (IA-TA-ER) injections over 4 months for: (1) pain severity and analgesic use; and (2) physical function (from Knee Injury and Osteoarthritis Outcome Score for Joint Replacement). METHODS: Patients who had unilateral knee OA and received nonoperative intervention were enrolled in the Innovations in Genicular Outcomes Research registry, a novel, multicenter real-world registry, between September 2021 and February 2024. A total of 480 patients were enrolled. Both pain and functional outcomes were assessed at baseline, weekly, and monthly, which were analyzed by overall trend, magnitude changes pretreatment to post-treatment, and distribution-based minimally clinically important difference (MCID) score. Multivariate linear regressions with adjustments for 7 confounding factors were used to compare follow-up outcomes among 6 treatment groups. RESULTS: Use of IA-TA-ER injections was associated with the lowest pain, greatest pain reduction, and highest prevalence of patients achieving MCID relative to other treatments (P < .001). Deep/Both-Cryo and IA-CS were associated with a higher prevalence of achieving MCID than IA-HA, IA-NSAIDs, and Cryo-Superficial (P ≤ .001). Use of IA-TA-ER was also associated with the greatest functional score, improvement from baseline, and highest prevalence of patients achieving MCID than other treatments (P ≤ .003). CONCLUSIONS: The IA-TA-ER appears to outperform other treatments in terms of pain relief and functional improvement for up to 4 months following treatment. In addition, outcomes in the novel cryoneurolysis and conventional IA-CS were similar to one another and better than those in IA-HA and IA-NSAIDs.
RESUMEN
BACKGROUND: Intra-articular corticosteroid injections may cause hyperglycemia (glucose level >180 mg/dL). In a phase 2 study of 33 patients who had osteoarthritis of the knee and type 2 diabetes mellitus, triamcinolone acetonide extended-release (TA-ER) was associated with minimal glycemic control disruption compared with triamcinolone acetonide immediate-release (TA-IR). This post hoc analysis characterizes the clinical relevance of these results. METHODS: Patients who had symptomatic osteoarthritis of the knee for ≥6 months, type 2 diabetes mellitus for ≥1 year, and hemoglobin A1c ≥6.5 and ≤9.0% were randomized to receive an intra-articular injection of either TA-ER or TA-IR. Changes in continuous glucose monitor daily glucose level, percentage of time in or above the target glucose range (>70 to 180 mg/dL), time to glucose level 250 mg/dL and maximum glucose level >250 mg/dL, and glycemic variability were evaluated. RESULTS: Across postinjection days 1 to 3, the TA-ER group (n = 18) had a lower median change from baseline in maximum glucose level (92.3 versus 169.1 mg/dL), a reduced percentage of time with a glucose level >250 mg/dL (12 versus 26%), a smaller proportion of patients who had a maximum glucose level >250 mg/dL (50 versus 93%), and a greater percentage of time in the target glucose range (62 versus 48%) versus the TA-IR group (n = 15). There was less glycemic variability and lower glucose spikes in the TA-ER versus TA-IR group. Median times to glucose level 250 mg/dL (44 versus 6 hours) and maximum glucose level (34 versus 13 hours) were significantly longer in the TA-ER versus TA-IR group. CONCLUSIONS: Use of TA-ER was associated with a clinically meaningful reduction in hyperglycemia versus TA-IR.
RESUMEN
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 <40â¯kg/m2 undergoing elective distal metaphyseal osteotomy. INTERVENTIONS: Part A participants were randomized 1:1:1 to LB 266â¯mg, LB 133â¯mg, or bupivacaine hydrochloride 50â¯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 0-96â¯h after surgery. Secondary endpoints included total postsurgical opioid consumption, opioid-free status 0-96â¯h after surgery, and pharmacokinetic endpoints. MAIN RESULTS: Part A enrolled 22 participants per group. In part B, additional participants were randomized to LB 133â¯mg (nâ¯=â¯59) and BUPI (nâ¯=â¯60) (185 total). LB 133â¯mg had significant reductions versus BUPI in the AUC of NRS pain intensity score (least squares mean [LSM], 207.4 vs 371.4; Pâ¯<â¯0.00001) and total opioid consumption 0-96â¯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; Pâ¯<â¯0.00001) and an increased proportion of opioid-free participants (24.4% vs 6%; odds ratio, 5.04 [95% CI, 2.01, 12.62]; Pâ¯=â¯0.0003) in parts Aâ¯+â¯B. Adverse events were similar across groups. CONCLUSIONS: LB 133â¯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 4â¯days after surgery and a significantly greater percentage of participants remaining opioid-free.
Asunto(s)
Anestésicos Locales , Dolor Postoperatorio , Adulto , Humanos , Analgésicos Opioides , Bupivacaína , Liposomas , Dolor Postoperatorio/tratamiento farmacológico , Dolor Postoperatorio/etiología , Dolor Postoperatorio/prevención & control , Nervio CiáticoAsunto(s)
Artroplastía de Reemplazo de Hombro , Bloqueo del Plexo Braquial , Humanos , Bupivacaína/efectos adversos , Artroplastía de Reemplazo de Hombro/efectos adversos , Bloqueo del Plexo Braquial/efectos adversos , Anestésicos Locales/efectos adversos , Dolor Postoperatorio/diagnóstico , Dolor Postoperatorio/etiología , Dolor Postoperatorio/prevención & control , HombroAsunto(s)
Anestésicos Locales , Bupivacaína , Humanos , Dexametasona , Dolor Postoperatorio , LiposomasRESUMEN
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.
Asunto(s)
Gastroplastia , Obesidad Mórbida/cirugía , Obesidad Infantil/cirugía , Adolescente , Índice de Masa Corporal , Comorbilidad , Femenino , Estudios de Seguimiento , Gastroplastia/efectos adversos , Gastroplastia/métodos , Gastroplastia/estadística & datos numéricos , Humanos , Laparoscopía/efectos adversos , Laparoscopía/métodos , Laparoscopía/estadística & datos numéricos , Estudios Longitudinales , Masculino , Obesidad Mórbida/epidemiología , Obesidad Infantil/epidemiología , Resultado del Tratamiento , Pérdida de Peso/fisiologíaRESUMEN
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.
Asunto(s)
Gastroplastia/métodos , Laparoscopía/métodos , Obesidad Mórbida/cirugía , Obesidad Infantil/cirugía , Adolescente , Índice de Masa Corporal , Peso Corporal , Femenino , Estudios de Seguimiento , Humanos , Masculino , Cuidados Posoperatorios , Complicaciones Posoperatorias/etiología , Estudios Prospectivos , Resultado del Tratamiento , Pérdida de Peso , Adulto JovenRESUMEN
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.
Asunto(s)
Gastroplastia/métodos , Obesidad Mórbida/cirugía , Adolescente , Adulto , Índice de Masa Corporal , Femenino , Gastroplastia/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Obesidad Mórbida/complicaciones , Complicaciones Posoperatorias/etiología , Reoperación/estadística & datos numéricos , Estudios Retrospectivos , Resultado del Tratamiento , Pérdida de Peso/fisiología , Adulto JovenRESUMEN
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 Asunto(s)
Diabetes Mellitus Tipo 2/cirugía
, Derivación Gástrica
, Obesidad Mórbida/cirugía
, Adulto
, Glucemia/análisis
, Diabetes Mellitus Tipo 2/epidemiología
, Diabetes Mellitus Tipo 2/etiología
, Femenino
, Estudios de Seguimiento
, Humanos
, Incidencia
, Masculino
, Persona de Mediana Edad
, Obesidad Mórbida/complicaciones
, Recurrencia
RESUMEN
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).
Asunto(s)
Índice de Masa Corporal , Gastroplastia/métodos , Laparoscopía/métodos , Obesidad/cirugía , Pérdida de Peso/fisiología , Adulto , Femenino , Estudios de Seguimiento , Humanos , Masculino , Obesidad/fisiopatología , Factores de Tiempo , Resultado del TratamientoRESUMEN
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.
Asunto(s)
Derivación Gástrica , Gastroplastia , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Obesidad Mórbida/cirugía , Reoperación , Insuficiencia del Tratamiento , Pérdida de PesoRESUMEN
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.
Asunto(s)
Derivación Gástrica , Gastroplastia , Pérdida de Peso , Adulto , Índice de Masa Corporal , Femenino , Estudios de Seguimiento , Humanos , Masculino , Obesidad Mórbida/cirugía , Periodo Posoperatorio , Estudios Retrospectivos , Factores SexualesRESUMEN
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.
Asunto(s)
Resorción Ósea/metabolismo , Calcio/metabolismo , Derivación Gástrica , Gastroplastia , Obesidad Mórbida/metabolismo , Obesidad Mórbida/cirugía , Adolescente , Adulto , Anciano , Fosfatasa Alcalina/metabolismo , Biomarcadores/metabolismo , Resorción Ósea/etiología , Calcifediol/sangre , Estudios de Cohortes , Femenino , Humanos , Laparoscopía , Masculino , Persona de Mediana Edad , Obesidad Mórbida/complicaciones , Hormona Paratiroidea/sangre , Estudios Retrospectivos , Adulto JovenRESUMEN
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.
Asunto(s)
Adenocarcinoma , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Pancreatectomía , Neoplasias Pancreáticas , Adenocarcinoma/tratamiento farmacológico , Adenocarcinoma/mortalidad , Adenocarcinoma/radioterapia , Anciano , Antimetabolitos Antineoplásicos/administración & dosificación , Capecitabina , Contraindicaciones , Desoxicitidina/administración & dosificación , Desoxicitidina/análogos & derivados , Estudios de Factibilidad , Femenino , Fluorouracilo/administración & dosificación , Fluorouracilo/análogos & derivados , Humanos , Masculino , Persona de Mediana Edad , Terapia Neoadyuvante/métodos , Neoplasias Pancreáticas/tratamiento farmacológico , Neoplasias Pancreáticas/mortalidad , Neoplasias Pancreáticas/radioterapia , Profármacos , Estudios Prospectivos , Fármacos Sensibilizantes a Radiaciones/administración & dosificación , Ribonucleótido Reductasas/antagonistas & inhibidores , Tasa de Supervivencia/tendencias , Resultado del Tratamiento , Estados Unidos/epidemiología , GemcitabinaRESUMEN
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.
Asunto(s)
Derivación Gástrica/métodos , Obesidad Mórbida/cirugía , Adulto , Análisis de Varianza , Distribución de Chi-Cuadrado , Comorbilidad , Método Doble Ciego , Femenino , Humanos , Masculino , Complicaciones Posoperatorias , Estudios Prospectivos , Resultado del TratamientoRESUMEN
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.