Outcomes of minimally invasive versus open abdominal hysterectomy in patients with gestational trophoblastic disease.

OBJECTIVE: The aim of this study is to compare surgical and oncologic outcomes for women undergoing MIH or open abdominal hysterectomy (OAH) for management of gestational trophoblastic disease (GTD). METHODS: Patients who underwent hysterectomy for GTD between January 1, 2009 and December 31, 2018 were identified using an institutional database and tumor registry. Patients were stratified based on indication for and mode of hysterectomy. RESULTS: 39 patients underwent hysterectomy for GTD - 22 MIH and 17 OAH. 26 hysterectomies (66.7%) were performed for primary treatment of GTD, 7 (17.9%) for chemoresistance, 2 (5.1%) for uterine hemorrhage, and 4 (10.3%) for other indications. Mean tumor size (4.2 vs 4.6 cm; p = .81) and operative time (136 vs 163 mins; p = .42) were similar in both groups. MIH was associated with significantly less blood loss (71.5 vs 427.3 ml; p = .03) and shorter hospital stay (1.5 vs 3.9 days, p = .02) than OAH. Postoperative histology comprised 12 complete moles (6 invasive), 8 choriocarcinomas, 9 placental site trophoblastic tumors and 9 epithelioid trophoblastic tumors. Median follow-up was 67.2 months (50.2 MIH, 79.3 OAH; range 11.1-131.2) and there was no difference in remission (81.8% MIH vs 76.5% OAH; p = .68). There were 7 recurrences (4 MIH, 3 OAH) and 3 deaths (2 MIH, 1 OAH). Overall survival was 97.3% at 2 years and 88.5% at 5 years. There was no significant difference in 5-year survival by mode of surgery (MIH 90.9%, OAH 83.3%; p = .40). CONCLUSIONS: Patients undergoing MIH at our centers have similar oncologic outcomes, lower surgical blood loss and shorter hospital stay compared to those undergoing OAH. Overall survival is similar regardless of mode of surgery.

Multivariable analysis of association of beta-blocker use and survival in advanced ovarian cancer.

OBJECTIVE: In this study, we sought to evaluate the relationship between survival and beta blocker use in both the primary and interval debulking setting while adjusting for frequently co-administered medications. METHODS: We performed a retrospective cohort study reviewing charts of women who underwent primary or interval cytoreduction for stage IIIC and IV epithelial ovarian cancer. The exposure of interest was beta-blocker use identified at the time of cytoreduction. The outcomes of interest were PFS and OS. We collected demographic/prognostic variables and information about use of aspirin, metformin, and statins. We used the Kaplan-Meier method and Cox proportional hazards models in survival analyses. RESULTS: 534 women who underwent surgery for stage IIIC or IV ovarian cancer were included in the study. The median age at diagnosis was 64 and 84.8% of women had serous carcinoma. We identified 105 women (19.7%) on a beta-blocker of whom 94 (90%) were on a cardioselective beta-blocker. Additionally, 24 women (4.5%) were on metformin, 91 (17%) on aspirin, and 128 (24%) on a statin. In univariable analysis, beta-blocker users had a median overall survival of 29 months vs 35 months among non-users (hazard ratio HR = 1.52, p = 0.007). After adjustment for important demographic, clinical, and histopathologic factors, as well as use of other common medications, beta-blocker use remain associated with an increased hazard of death (adjusted HR 1.57, p = 0.006). CONCLUSION: In this retrospective study, we found that patients identified as being on a beta-blocker at the time of surgery had worse overall survival and greater risk of death when compared to those patients not on betablockers. Importantly, 90% of patients on beta-blockers were identified as being on a cardioselective beta-blocker.

A randomized controlled trial of lorcaserin and lifestyle counselling for weight loss maintenance: changes in emotion- and stress-related eating, food cravings and appetite.

Anti-obesity medication may help people maintain diet-induced reductions in appetite. The present exploratory analysis assessed the effects of lorcaserin on changes at 24 weeks post-randomization in emotion- and stress-related eating, food cravings and other measures of appetite (i.e. binge eating, cognitive restraint, disinhibition, hunger, preoccupation with eating and fullness). The parent study investigated the efficacy of combined lorcaserin and behavioural treatment in facilitating weight loss maintenance (WLM) in 137 adults (mean age = 46.1 years, 86.1% female, 68.6% black) who had lost ≥5% of initial weight during a 14-week, low-calorie diet (LCD) run-in. Participants were randomly assigned to lorcaserin or placebo and were provided with group WLM counselling sessions. Emotion- and stress-related eating, food cravings and appetite were measured at the start of the LCD (week -14), randomization (0) and week 24. From randomization, lorcaserin-treated participants had significantly greater improvements in emotion- and stress-related eating compared to placebo-treated participants (P = 0.04). However, groups did not differ significantly after randomization in changes in the frequency of food cravings, binge eating or other measures of appetite (Ps > 0.05). Compared to placebo, lorcaserin may improve emotion- and stress-related eating.

Observed parent-child feeding dynamics in relation to child body mass index and adiposity.

BACKGROUND: Restrictive feeding is associated with child overweight; however, the majority of studies used parent-report questionnaires. OBJECTIVES: The relationship between child adiposity measures and directly observed parent and child behaviours were tested using a novel behavioural coding system (BCS). METHODS: Data from 109 children, participants in a twin study and their mothers, were analyzed. Parent-child dyads were video-recorded twice in the laboratory, while children ate ad libitum from a buffet lunch. Mother and child behaviours were assessed using the BCS. Height, body weight and body fat were directly measured for each child. Associations between child adiposity measures and average BCS behaviour (i.e. pooled across visits) were tested using partial correlations adjusting for child age. RESULTS: Regarding discouragement prompts, child body mass index (BMI) z-score was significantly associated with a greater rate of total discouragements (per minute, min-1 ), nonverbal discouragements (min-1 ) and temporary (delay) discouragements (min-1 ) (p < 0.05). Child percent body fat was associated with greater nonverbal discouragements (min-1 ). Regarding encouragement prompts, child BMI z-score was significantly associated with a greater rate of total encouragements (min-1 ), nonverbal encouragements (min-1 ) and reward encouragements (min-1 ). Child BMI z-score and percent body fat were both positively associated with greater maternal health encouragements (min-1 ). Associations with encouragement to eat prompts were no longer significant when accounting for the dependence among twins (being part of the same family). CONCLUSIONS: Heavier children received greater maternal discouragements to eat and, with qualifications, encouragements to eat. The role of nonverbal parenting cues warrants further research regarding child eating regulation and obesity.

Everyday discrimination in a racially diverse sample of patients with obesity.

Weight discrimination affects a significant proportion of individuals with obesity and contributes to poor mental and physical health. Prior research on weight discrimination has been limited by a lack of racial diversity in samples and has not considered other potential forms of discrimination that individuals with obesity may experience. The current study assessed different reasons for discrimination in a racially diverse sample of treatment-seeking individuals with obesity (N = 122, 66.4% black, mean body mass index = 38.5 ± 6.2 kg/m2 ). Results showed that over half of participants reported experiencing at least one form of repeated discrimination, and 30% reported two or more reasons for discrimination. Race and weight were the most commonly reported reasons for repeated, everyday instances of discrimination. Among participants who reported experiencing weight discrimination (28.7%), over 80% reported experiencing at least one other form of discrimination, with 60% reporting discrimination due to race. These findings indicate that individuals with obesity may face multiple forms of discrimination in their daily lives. Further research is needed to understand how all forms of discrimination contribute to obesity-related health problems.

Carbon Dioxide-Based versus Saline Tissue Expansion for Breast Reconstruction: Results of the XPAND Prospective, Randomized Clinical Trial.

BACKGROUND: AeroForm is a new type of remote-controlled, needle-free, carbon dioxide-based expander involving a potentially faster method of tissue expansion. Results are presented here from the AirXpanders Patient Activated Controlled Tissue Expander pivotal trial comparing AeroForm to saline tissue expanders. METHODS: Women undergoing two-stage breast reconstruction were randomized at 17 U.S. sites in this U.S. Food and Drug Administration-approved investigational device exemption trial. Expansion in the investigational arm was performed by the patient in 10-cc increments up to 30 cc/day of carbon dioxide and in the control arm by the physician with periodic bolus injections of saline. Safety endpoints, expansion and reconstruction times, pain, and satisfaction were assessed. RESULTS: One hundred fifty women were treated: 98 with carbon dioxide expanders (n = 168) and 52 with saline expanders (n = 88). The treatment success rate (all breasts exchanged successfully excluding non-device-related failures) was 96.1 percent for carbon dioxide and 98.8 percent for saline. Median time to full expansion and completion of the second-stage operation was 21.0 and 108.5 days (carbon dioxide) versus 46.0 and 136.5 days (saline), respectively, with a similar rate of overall complications. Ease of use for the carbon dioxide expander was rated high by patients (98 percent) and physicians (90 percent). CONCLUSIONS: The AirXpanders Patient Activated Controlled Tissue Expander trial results demonstrate that a carbon dioxide-based expander is an effective method of tissue expansion with a similar overall adverse event rate compared to saline expanders, and provides a more convenient and expedient expansion. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

High energy expenditure is not protective against increased adiposity in children.

BACKGROUND: Low levels of energy expenditure (TEE) may contribute to excess weight during childhood, but limited longitudinal data exist. OBJECTIVES: This is to test whether low TEE during the first 6 years of life could predict excess weight status at 8 years. METHODS: Total energy expenditure from doubly labelled water, weight, stature, waist circumference and fat mass and fat-free mass (FFM) in children at 0.25, 2, 4 and 6 years of age. This cohort includes individuals at high (n = 27) and low risk (n = 26) for childhood obesity, based upon whether pre-pregnant maternal obesity. A linear mixed effects model was fit to TEE. Individual variation was accounted for as a random effect. Residual TEE was calculated for age and individually averaged across time. RESULTS: Fat-free mass (kg) was highly correlated (R2 = 0.91) with TEE (kcal/day), and waist circumference and sex were also significant predictors of TEE. TEE residual tracked within individuals. TEE residuals did not correlate with either BMI or %fat at age 8 years. CONCLUSION: Using the residual TEE approach to identify high and low TEE during the first 6 years of life did not explain excess weight at 8 years of life in this cohort of children at high and low risk of obesity based upon maternal obesity status.

Management of the Nasal Dorsum: Construction and Maintenance of a Barrel Vault.

Rhinoplasty is not so much an art, but rather an architectural undertaking: a methodical approach to reconfiguring the nasal components to give a proportionate nose that both pleases the eye and satisfies functional requirements. The dorsum and dorsal esthetic lines are some of the most important components of the nose in terms of esthetics and function. The middle vault is the critical portion of the nose that will guide the management of the bony vault and the tip. The role of the spreader flap and its extension into the bony vault is stressed to re-create the barrel vaultlike nasal architecture.

Carbon Dioxide versus Saline Tissue Expanders: Does It Matter?

BACKGROUND: Implant-based breast reconstruction is the most common reconstructive technique in the United States. Despite its popularity, saline-based tissue expansion still has its limitations, including lengthy expansion times, large uncomfortable bolus dosing, and frequent percutaneous injections/expansion visits. Ideally, a novel technology would eliminate frequent, percutaneous saline injections and allow patients to perform expansion at home, reducing the disruptive experience of current tissue expansion. METHODS: Within the past 6 years, the AeroForm tissue expander system has used remotely activated carbon dioxide release as the fill medium instead of saline, eliminating many limitations of traditional tissue expanders. In this article, the authors first review the relevant literature concerning carbon dioxide-based tissue expansion in animal and human models. The authors then analyze the similarities and differences between two groundbreaking human trials (i.e., Patient Activated Controlled Expansion and AirXpanders Patient Activated Controlled Tissue Expander) with carbon dioxide-based expanders and discuss the risks and benefits associated with this new technology. RESULTS: At their site, the authors have enrolled 34 patients using 36 experimental devices in total, and have found significantly shorter expansion and overall reconstruction times in the patient-controlled tissue expander group. CONCLUSIONS: The authors believe that carbon dioxide-based devices may play a significant role in the future of implant-based breast reconstruction, and may be widely applicable to other areas of plastic surgery that also involve tissue expansion.

Desmopressin as a hemostatic agent to provide a dry intraoperative field in rhinoplasty.

BACKGROUND: Intraoperative bleeding during rhinoplasty makes it difficult to sculpt cartilages. Residual blood from a wet field can lead to induration, fibrosis, and definition loss. Recent studies with desmopressin (1-deamino-8-D-arginine vasopressin) to reduce blood loss in a variety of operations and minimize postoperative bleeding problems suggest using that drug routinely for elective rhinoplasty and not just for patients with coagulation issues. METHOD: Seventy-three consecutive rhinoplasty patients received desmopressin for the purpose of obtaining a dry operative field. The initial dose was 0.1 µg/kg. If the field was not as dry as desired, a second dose was given; if necessary, a third dose to a maximum of 0.3 µg/kg was given. All cases exhibited a satisfactorily dry field. There were no adverse effects. A retrospective comparison was made to 300 consecutive cases not receiving desmopressin. RESULTS: Thirty of the 73 patients received a starting dose of 0.1 µg/kg and nothing more. Fourteen received a second dose of 0.1 µg/kg because the field was not as dry as desired and 29 received a third dose of 0.1 µg/kg because the field was not as dry as desired. All 73 patients exhibited a satisfactorily dry field, in contrast to 9 percent in the group not receiving desmopressin. CONCLUSIONS: This study confirms the hemostatic effectiveness of desmopressin at lower than normally used doses in rhinoplasty. It also confirms its safety. It suggests its use in other procedures. A larger, carefully controlled study is indicated. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Epithelioid trophoblastic tumor: A single institution case series at the New England Trophoblastic Disease Center.

OBJECTIVE: Epithelioid trophoblastic tumor (ETT) is a rare form of gestational trophoblastic neoplasm which is distinct based on its development from intermediate trophoblast cells and nodular growth pattern. The aim of this study is to describe a case series from a single institution with a review of the literature to better understand the clinical characteristics and outcomes for patients with ETT. METHODS: A retrospective review was performed using the IRB approved New England Trophoblastic Disease Center (NETDC) database from 1998 to 2014. Eight patients were identified of which seven had complete records. Follow-up data was obtained from the longitudinal medical records. RESULTS: Four (57.1%) patients presented with vaginal bleeding and two (28.6%) patients were asymptomatic at presentation. Three (42.9%) patients had extrauterine disease. All three patients with extrauterine disease who received chemotherapy had stable or progressive disease at follow-up. Only two (29%) patients who presented with non-metastatic disease and underwent hysterectomy were alive with no evidence of disease. The mean interval following antecedent pregnancy was 104months. All patients with an interval >4years demonstrated stable or progressive disease despite intensive chemotherapy. Two patients with non-metastatic disease who declined hysterectomy developed stable or progressive disease despite chemotherapy. CONCLUSIONS: This series highlights several features of ETT including the potential for asymptomatic presentation of extrauterine disease. The series also demonstrates chemoresistance, even with multi-agent therapy and a poor prognosis with extrauterine disease and an interval greater than 4years following the antecedent pregnancy suggesting that surgery remains critical in disease control.

Prevention of excess weight gain in paediatric primary care: beverages only or multiple lifestyle factors. The Smart Step Study, a cluster-randomized clinical trial.

BACKGROUND: Insufficient evidence exists to support obesity prevention in paediatric primary care. OBJECTIVES: To test a theory-based behaviour modification intervention delivered by trained paediatric primary care providers for obesity prevention. METHODS: Efficacy trial with cluster randomization (practice level) and a 12-session 12-month sweetened beverages decrease intervention or a comprehensive dietary and physical activity intervention, compared with a control intervention among children ages 8-12 years. RESULTS: A low recruitment rate was observed. The increase in body mass index z-score (BMIz) for the 139 subjects (11 practices) randomized to any of the two obesity interventions (combined group) was less than that of the 33 subjects (five practices) randomized to the control intervention (-0.089, 95% confidence interval [CI]: -0.170 to -0.008, P = 0.03) with a -1.44 kg weight difference (95% CI: -2.98 to +0.10 kg, P = 0.095). The incidences of obesity and excess weight gain were lower in the obesity interventions, but the number of subjects was small. Post hoc analyses comparing the beverage only to the control intervention also showed an intervention benefit on BMIz (-0.083, 95% CI: -0.165 to -0.001, P = 0.048). CONCLUSIONS: For participating families, an obesity prevention intervention delivered by paediatric primary care clinicians, who are compensated, trained and continuously supported by behavioural specialists, can impact children's BMIz.

AeroForm patient controlled tissue expansion and saline tissue expansion for breast reconstruction: a randomized controlled trial.

BACKGROUND: Prosthetic reconstruction of the breast, as a 2-staged procedure using tissue expanders followed by placement of permanent implants, offers favorable aesthetic results with minimal additional surgical intervention. However, the current outpatient process to fill saline expanders can be lengthy and onerous, involving months of office visits and discomfort from the bolus saline expansions. We present a new technology (AeroForm Tissue Expansion System), which has the potential to improve the process of breast tissue expansion by providing a method for low-volume incremental filling, eliminating the need for injections and directly involving the patient by allowing her some control over the expansion process. METHODS: The described study is a 2:1 randomized controlled trial of the investigational CO2 expansion system and saline expanders. Of the 82 women receiving expanders, 58 (39 bilateral and 19 unilateral; bilateral rate, 67%) were implanted with CO2 tissue expanders and 24 subjects (15 bilateral and 9 unilateral; bilateral rate, 63%) were implanted with saline expanders. RESULTS: Preliminary validated expansion results were available for 55 women. Available mean time for active expansion in the CO2 group was 18.2 (9.2) days (median, 14.0; range, 5-39; number of expanders, 53), which was less than the mean time for active expansion in the saline group: 57.4 (33.6) days (median, 55; range, 5-137; number of expanders, 33). Available mean time from implant placement to exchange for a permanent prosthesis in the CO2 group was shorter [106.3 (42.9) days; median, 99; range, 42-237; number of expanders, 53] than for the women in the control group [151.7 (62.6) days; median, 140; range, 69-433; number of expanders, 33]. After 2 events--underexpansion (n=1) and erosion (n=1)--in the CO2 group, the internal membrane was redesigned and the expander bulk was decreased to minimize the risk of underexpansion and erosion in subsequent patients. CONCLUSIONS: Preliminary evidence indicates that the CO2-based tissue expansion system performs the same function as saline expansion devices without significantly altering the risk to the patient and that the device has the potential to make the expansion process faster and more convenient for both the patient and the physician.

Change in body composition during a weight loss trial in obese adolescents.

UNLABELLED: What is already known about this subject Adolescence is an important period of physiological growth. Loss of central adiposity with preservation of lean mass during weight loss is optimal. There are discrepancies in the literature concerning changes in lean mass during weight loss in adolescents. What this study adds This study provides information of regional and total body composition change in adolescents during weight loss. This study controls for important factors that impact body composition in growing adolescents such as age, sex, height, baseline weight and race. This study provides correlations of changes in waist circumference and body mass index (BMI) with total and trunk fat mass during weight loss in adolescents. SUMMARY: Background Changes in body composition during weight loss among obese adolescents are poorly understood. This study characterized the composition of weight loss and its association with changes in waist circumference (WC) in obese adolescents. Methods Total (Tot), trunk (Tr) and appendicular (Ap) fat mass (FM) and lean mass (LM) were measured by dual-energy X-ray absorptiometry in 61 obese adolescents (40 girls) who participated in a randomized controlled weight loss trial. Changes in body composition were assessed at 0, 6 and 12 months using mixed-effects regression models. Correlation analysis of change in WC and total and regional compartments of FM and LM were assessed. Results Weight loss for adolescents was 90.3% FM and 15.9% LM at 0-6 months, and 98.2% FM and 7% LM at 0-12 months. At 12 months, girls lost 2.67 kg more TotFM than boys in models adjusted for height, age, race and baseline weight. Boys gained LM in all compartments in all models. At 12 months, girls lost TotLM (2.23 ± 0.74, P < 0.004) and ApLM (0.69 ± 0.31, P = 0.03) and gained TrLM (0.37 ± 0.35, P = 0.29). The percentage LM, increased for boys and girls in all models. TotFM was correlated with body mass index (BMI) change with TotFM (R = 0.70-0.91, P = 0.001) and WC change (R = 0.53-0.55, P < 0.001). Conclusions Weight loss in obese adolescents during a weight loss trial using lifestyle management and sibutramine was primarily from trunk FM. Although absolute LM increased in boys and decreased in girls, the percentage of weight that is LM increased for both boys and girls. Changes in BMI were more reflective of changes in FM than changes in WC.

Changes in eating, physical activity and related behaviors in a primary care-based weight loss intervention.

OBJECTIVE: To examine changes in eating behaviors and physical activity, as well as predictors of weight loss success, in obese adults who participated in a 2-year behavioral weight loss intervention conducted in a primary care setting. DESIGN: A longitudinal, randomized controlled, multisite trial. SUBJECTS: Three hundred ninety obese (body mass index, 30-50 kg m(-2)) adults, ≥ 21 years, in the Philadelphia region. METHODS: Participants were assigned to one of three interventions: (1) Usual Care (quarterly primary care provider (PCP) visits that included education on diet and exercise); (2) Brief Lifestyle Counseling (quarterly PCP visits plus monthly lifestyle counseling (LC) sessions about behavioral weight control); or (3) Enhanced Brief LC (the previous intervention with a choice of meal replacements or weight loss medication). RESULTS: At month 24, participants in both Brief LC and Enhanced Brief LC reported significantly greater improvements in mean (± s.e.) dietary restraint than those in Usual Care (4.4 ± 0.5, 4.8 ± 0.5 and 2.8 ± 0.5, respectively; both P-values ≤ 0.016). The percentage of calories from fat, along with fruit and vegetable consumption, did not differ significantly among the three groups. At month 24, both the Brief LC and Enhanced Brief LC groups reported significantly greater increases than usual care in energy expenditure (kcal per week) from moderately vigorous activity (+593.4 ± 175.9, +415.4 ± 179.6 and -70.4 ± 185.5 kcal per week, respectively; both P-values ≤ 0.037). The strongest predictor of weight loss at month 6 (partial R(2)=33.4%, P<0.0001) and at month 24 (partial R(2)=19.3%, P<0.001) was food records completed during the first 6 months. Participants who achieved a 5% weight loss at month 6 had 4.7 times greater odds of maintaining a ≥ 5% weight loss at month 24. CONCLUSIONS: A behavioral weight loss intervention delivered in a primary care setting can result in significant weight loss, with corresponding improvements in eating restraint and energy expenditure. Moreover, completion of food records, along with weight loss at month 6, is a strong predictor of long-term weight loss.

The impact of a primary care-based weight loss intervention on the quality of life.

OBJECTIVE: This study investigated changes in the quality of life of men and women who participated in a primary care-based weight loss intervention program. METHODS: Participants were enrolled in a 2-year randomized clinical trial (POWER-UP) conducted at the University of Pennsylvania and in six affiliated primary care practices. Inclusion criteria included the presence of obesity (body mass index of 30-50 kg m(-2)) and at least two components of the metabolic syndrome. MAIN OUTCOME MEASURES: Quality of life was assessed by three measures: the Short Form Health Survey (SF-12); the Impact of Weight on Quality of Life-Lite; and the EuroQol-5D. RESULTS: Six months after the onset of treatment, and with a mean weight loss of 3.9 ± 0.3 kg, participants reported significant improvements on all measures of interest with the exception of the Mental Component Score of the SF-12. These changes remained significantly improved from baseline to month 24, with the exception of the EuroQol-5D. Many of these improvements were correlated with the magnitude of weight loss and, for the most part, were consistent across gender and ethnic group. CONCLUSIONS: Individuals with obesity and components of the metabolic syndrome reported significant improvements in most domains of the quality of life with a modest weight loss of 3.7% of initial weight, which was achieved within the first 6 months of treatment. The majority of these improvements were maintained at month 24, when participants had lost 3.0% of their weight.