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Postoperative intravenous parecoxib sodium followed by oral celecoxib post total knee arthroplasty in osteoarthritis patients (PIPFORCE): a multicentre, double-blind, randomised, placebo-controlled trial.
Zhuang, Q, Tao, L, Lin, J, Jin, J, Qian, W, Bian, Y, Li, Y, Dong, Y, Peng, H, Li, Y, et al
BMJ open. 2020;(1):e030501
Abstract
OBJECTIVES To evaluate the morphine-sparing effects of the sequential treatment versus placebo in subjects undergoing total knee arthroplasty (TKA), the effects on pain relief, inflammation control and functional rehabilitation after TKA and safety. DESIGN Double-blind, pragmatic, randomised, placebo-controlled trial. SETTING Four tertiary hospitals in China. PARTICIPANTS 246 consecutive patients who underwent elective unilateral TKA because of osteoarthritis (OA). INTERVENTIONS Patients were randomised 1:1 to the parecoxib/celecoxib group or the control group. The patients in the parecoxib/celecoxib group were supplied sequential treatment with intravenous parecoxib 40 mg (every 12 hours) for the first 3 days after surgery, followed by oral celecoxib 200 mg (every 12 hours) for up to 6 weeks. The patients in the control group were supplied with the corresponding placebo under the same instructions. PRIMARY AND SECONDARY OUTCOME MEASURES The primary endpoint was the cumulative opioid consumption at 2 weeks post operation (intention-to-treat analysis). Secondary endpoints included the Knee Society Score, patient-reported outcomes and the cumulative opioid consumption. RESULTS The cumulative opioid consumption at 2 weeks was significantly smaller in the parecoxib/celecoxib group than in the control group (median difference, 57.31 (95% CI 34.66 to 110.33)). The parecoxib/celecoxib group achieving superior Knee Society Scores and EQ-5D scores and greater Visual Analogue Scale score reduction during 6 weeks. Interleukin 6, erythrocyte sedation rate and C-reactive protein levels were reduced at 72 hours, 2 weeks and 4 weeks and prostaglandin E2 levels were reduced at 48 hours and 72 hours in the parecoxib/celecoxib group compared with the placebo group. The occurrence of adverse events (AEs) was significantly lower in the parecoxib/celecoxib group. CONCLUSIONS The sequential intravenous parecoxib followed by oral celecoxib regimen reduces morphine consumption, achieves better pain control and functional recovery and leads to less AEs than placebo after TKA for OA. TRIAL REGISTRATION NUMBER ClinicalTrials.gov (ID: NCT02198924).
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Effect of Face-Down Positioning vs Support-the-Break Positioning After Macula-Involving Retinal Detachment Repair: The PostRD Randomized Clinical Trial.
Casswell, EJ, Yorston, D, Lee, E, Heeren, TFC, Harris, N, Zvobgo, TM, Tarafdar, S, Xing, W, Bourmpaki, E, Bunce, C, et al
JAMA ophthalmology. 2020;(6):634-642
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IMPORTANCE A lack of consensus exists with regard to the optimal positioning regimen for patients after macula-involving retinal detachment (RD) repair. OBJECTIVE To evaluate the effect of face-down positioning vs support-the-break positioning on retinal displacement and distortion after macula-involving RD repair. DESIGN, SETTING, AND PARTICIPANTS A prospective 6-month single-masked randomized clinical trial was conducted at a multicenter tertiary referral setting from May 16, 2016, to May 1, 2018. Inclusion criteria were fovea-involving rhegmatogenous RD; central visual loss within 14 days; patients undergoing primary vitrectomy and gas surgery, under local anesthetic; patients able to give written informed consent; and 18 years old and older. Analysis was conducted following a modified intention-to-treat principle, with patients experiencing a redetachment or failure to attach the macula being excluded from analysis. INTERVENTIONS Participants were randomized 1:1 to receive face-down positioning or support-the-break positioning for a 24-hour period postoperatively. Positioning compliance was not monitored. MAIN OUTCOMES AND MEASURES The proportion of patients with retinal displacement on autofluorescence imaging at 6 months postoperatively. Secondary outcomes included proportion of patients with displacement at 2 months; amplitude of displacement at 2 and 6 months; corrected Early Treatment Diabetic Retinopathy Study visual acuity; objective Distortion Scores; and quality of life questionnaire scores at 6 months. RESULTS Of the 262 randomized patients, 239 were analyzed (171 male [71.5%]; mean [SD] age, 60.8 [9.8] years). At 6 months, retinal displacement was detected in 42 of 100 (42%) in the face-down positioning group vs 58 of 103 (56%) in the support-the-break positioning group (odds ratio, 1.77; 95%CI, 1.01-3.11; P = .04). The degree of displacement was lower in the face-down group. Groups were similar in corrected visual acuity (face-down, 74 letters vs support-the-break, 75 letters), objective D Chart Distortion Scores (range: 0, no distortion to 41.6, severe distortion; with face-down at 4.5 vs support-the-break at 4.2), and quality of life scores (face-down 89.3 vs support-the-break 89.0) at 2 and 6 months. Retinal redetachment rate was similar in both groups (face-down group, 12.2% and support-the-break group, 13.7%). Retinal folds were less common in the face-down positioning group vs the support-the-break positioning group (5.3% vs 13.5%, respectively; odds ratio, 2.8; 95% CI, 1.2-7.4; P = .03). Binocular diplopia was more common in the support-the-break group compared with the face-down positioning group (7.6% vs 1.5%, respectively; odds ratio, 5.3; 95% CI, 1.3-24.6; P = .03). Amplitude of displacement was associated with worse visual acuity (r = -0.5; P < .001) and distortion (r = 0.28; P = .008). CONCLUSIONS AND RELEVANCE In this study, findings suggest that face-down positioning was associated with a reduction in the rate and amplitude of postoperative retinal displacement after macula-involving RD repair and with a reduction in binocular diplopia. No association was found with visual acuity or postoperative distortion. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02748538.
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A Preliminary Report of the Biochemical and Clinical Effects of 1,4-Diaminobutane on Prevention of Human Hypertrophic Scars.
Dolynchuk, KN, Tredget, EE
Plastic and reconstructive surgery. 2020;(1):76e-84e
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Objective evidence for the role of inhibition of collagen cross-linking in human scar using a nontoxic topical inhibitor, 1,4-diaminobutane (1,4 DAB), in patients with scars at risk for hypertrophic scar formation is presented. The authors used a concentration of 1,4 DAB of 0.8% (weight/volume) in a cream base similar to Glaxal Base. Application was once per day at night. The control was treated with cream base alone. In treatment phase studies at 2 months, tissue biopsies were performed and used to determine a therapeutic effect biochemically in paired scars harvested chosen with typical hypertrophic scars at two major treatment centers. Tissue transglutaminase activity revealed a significant reduction of the ε-(γ-glutamyl)lysine cross-links in the treated scars: 7.96 ± 1.51 pmol/µmol amino acid versus 14.78 ± 3.52 pmol/µmol amino acid. A subset of paired scars (n = 15) was also analyzed for soluble procollagen type III amino propeptide. The effect was a significant increase in procollagen type III amino propeptide in the scars treated with 1,4 DAB compared with sham-treated scars: 47.75 ± 4.6 µg/mg wet weight versus 39.08 ± 6.02 µg/mg wet weight, respectively. Levels of tissue 1,4 DAB was found to be twice as high in the presence of the active cream versus in the tissue of the control group. In subsequent prophylaxis studies, the authors treated 44 breast reduction patients prospectively with active cream to one or the other side in a double-blind randomized fashion. Hardness (in grams) measured using a Rex Durometer at 6 and 12 weeks postoperatively along with photographs were analyzed. The mean value ± SD of 24.98 ± 1.2 g on the active side versus 31.76 ± 1.1 g on the sham side was significantly different (p < 0.05). The patient scale scores of the Patient and Observer Scar Assessment Scale were also requested by survey in a responding 27-patient subgroup at a minimum 1 year postoperatively, and the differences between the two sides were found to be statistically significant, where the mean on the active side was 14.07 ± 1.34 and the mean on the sham side was 21.41 ± 1 (p < 0.05). The results are evidence to support the use of this agent in prevention of hypertrophic scars. CLINICAL QUESTION/LEVEL OF EVIDENCE Therapeutic, II.
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Direct Oral Feeding Following Minimally Invasive Esophagectomy (NUTRIENT II trial): An International, Multicenter, Open-label Randomized Controlled Trial.
Berkelmans, GHK, Fransen, LFC, Dolmans-Zwartjes, ACP, Kouwenhoven, EA, van Det, MJ, Nilsson, M, Nieuwenhuijzen, GAP, Luyer, MDP
Annals of surgery. 2020;(1):41-47
Abstract
OBJECTIVE Patients undergoing an esophagectomy are often kept nil-by-mouth postoperatively out of fear for increasing anastomotic leakage and pulmonary complications. This study investigates the effect of direct start of oral feeding following minimally invasive esophagectomy (MIE) compared with standard of care. BACKGROUND Elements of enhanced recovery after surgery (ERAS) protocols have been successfully introduced in patients undergoing an esophagectomy. However, start of oral intake, which is an essential part of the ERAS protocols, remains a matter of debate. METHODS Patients in this multicenter, international randomized controlled trial were randomized to directly start oral feeding (intervention) after a MIE with intrathoracic anastomosis or to receive nil-by-mouth and tube feeding for 5 days postoperative (control group). Primary outcome was time to functional recovery. Secondary outcome parameters included anastomotic leakage, pneumonia rate, and other surgical complications scored by predefined definitions. RESULTS Baseline characteristics were similar in the intervention (n = 65) and control (n = 67) group. Functional recovery was 7 days for patients receiving direct oral feeding compared with 8 days in the control group (P = 0.436). Anastomotic leakage rate did not differ in the intervention (18.5%) and control group (16.4%, P = 0.757). Pneumonia rates were comparable between the intervention (24.6%) and control group (34.3%, P = 0.221). Other morbidity rates were similar, except for chyle leakage, which was more prevalent in the standard of care group (P = 0.032). CONCLUSION Direct oral feeding after an esophagectomy does not affect functional recovery and did not increase incidence or severity of postoperative complications.
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Enhanced recovery after surgery for radical cystectomy with ileal urinary diversion: a multi-institutional, randomized, controlled trial from the Chinese bladder cancer consortium.
Lin, T, Li, K, Liu, H, Xue, X, Xu, N, Wei, Y, Chen, Z, Zhou, X, Qi, L, He, W, et al
World journal of urology. 2018;(1):41-50
Abstract
PURPOSE Enhanced recovery after surgery (ERAS) has played an important role in recovery management for radical cystectomy with ileal urinary diversion (RC-IUD). This study is to evaluate ERAS compared with the conventional recovery after surgery (CRAS) for RC-IUD. METHODS From October 2014 and July 2016, bladder cancer patients scheduled for curative treatment from 25 centers of Chinese Bladder Cancer Consortium were randomly assigned to either ERAS or CRAS group. Primary endpoint was the 30-day complication rate. Secondary endpoints included recovery of fluid and regular diet, flatus, bowel movement, ambulation, and length of stay (LOS) postoperatively. Follow-up period was 30-day postoperatively. RESULTS There were 144 ERAS and 145 CRAS patients. Postoperative complications occurred in 25.7 and 30.3% of the ERAS and CRAS patients with 55 complications in each group, respectively (p = 0.40). There was no significant difference between groups in major complications (p = 0.82), or type of complications (p = 0.99). The ERAS group had faster recovery of bowel movements (median 88 versus 100 h, p = 0.01), fluid diet tolerance (68 versus 96 h, p < 0.001), regular diet tolerance (125 versus 168 h, p = 0.004), and ambulation (64 versus 72 h, p = 0.047) than the CRAS group, but similar time to flatus and LOS. CONCLUSIONS ERAS did not increase 30-day complications compared with CRAS after RC. ERAS may be better than CRAS in terms of bowel movement, tolerance of fluid and regular diet, and ambulation.
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Safety and efficacy of non-vitamin K oral anticoagulant for atrial fibrillation patients after percutaneous coronary intervention: A bivariate analysis of the PIONEER AF-PCI and RE-DUAL PCI trial.
Chi, G, Kerneis, M, Kalayci, A, Liu, Y, Mehran, R, Bode, C, Halperin, JL, Verheugt, FWA, Wildgoose, P, van Eickels, M, et al
American heart journal. 2018;:17-24
Abstract
BACKGROUND The tradeoff in safety versus efficacy in substituting a non-vitamin K antagonist oral anticoagulant for a vitamin K antagonist (VKA) in the stented atrial fibrillation patient has not been quantitatively evaluated. METHODS Based on summary data from the PIONEER AF-PCI and RE-DUAL PCI trials, 4 antithrombotic regimens were compared with VKA-based triple therapy: (1) rivaroxaban (riva) 15 mg daily + P2Y12 inhibitor, (2) riva 2.5 mg twice daily + P2Y12 inhibitor + aspirin, (3) dabigatran (dabi) 110 mg twice daily + P2Y12 inhibitor, and (4) dabi 150 mg twice daily + P2Y12 inhibitor. A bivariate model with a noninferiority margin of 1.38 was used to simultaneously assess safety and efficacy. The safety end point was major or clinically relevant nonmajor bleeding by International Society on Thrombosis and Haemostasis definitions. The efficacy end point was a thromboembolic event (myocardial infarction, stroke, or systemic embolism), death, or urgent revascularization. The bivariate outcome, a measure of risk difference in the net clinical outcome, was compared between antithrombotic regimens. RESULTS All 4 non-vitamin K antagonist oral anticoagulant regimens were superior in bleeding and noninferior in efficacy compared with triple therapy with VKA. Riva 15 mg daily and 2.5 mg twice daily were associated with bivariate combined risk reductions of 5.6% (2.3%-8.8%) and 5.5% (2.1%-8.7%), respectively, and dabi 110 mg twice daily and 150 mg twice daily reduced the bivariate risk by 3.8% (0.5%-7.0%) and 6.3% (2.4%-9.8%), respectively. CONCLUSIONS A bivariate analysis that simultaneously characterizes both risk and benefit demonstrates that riva- and dabi-based regimens were both favorable over VKA plus dual antiplatelet therapy among patients with atrial fibrillation undergoing PCI.
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Association Between Bariatric Surgery and Rates of Continuation, Discontinuation, or Initiation of Antidiabetes Treatment 6 Years Later.
Thereaux, J, Lesuffleur, T, Czernichow, S, Basdevant, A, Msika, S, Nocca, D, Millat, B, Fagot-Campagna, A
JAMA surgery. 2018;(6):526-533
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IMPORTANCE Few large-scale long-term prospective cohort studies have assessed changes in antidiabetes treatment after bariatric surgery. OBJECTIVE To describe the association between bariatric surgery and rates of continuation, discontinuation, or initiation of antidiabetes treatment 6 years after bariatric surgery compared with a matched control obese group. DESIGN, SETTING, AND PARTICIPANTS This nationwide observational population-based cohort study extracted health care reimbursement data from the French national health insurance database from January 1, 2008, to December 31, 2015. All patients undergoing primary bariatric surgery in France between January 1 and December 31, 2009, were matched on age, sex, body mass index category, and antidiabetes treatment with control patients hospitalized for obesity in 2009 with no bariatric surgery between 2005 and 2015. EXPOSURES Bariatric surgery, including adjustable gastric banding (AGB), gastric bypass (GBP), and sleeve gastrectomy (SG). MAIN OUTCOME AND MEASURE Reimbursement for antidiabetes drugs. Mixed-effects logistic regression models estimated factors of discontinuation or initiation of antidiabetes treatment over a period of 6 years. RESULTS In 2009, a total of 15 650 patients (mean [SD] age, 38.9 [11.2] years; 84.6% female; 1633 receiving antidiabetes treatment) underwent primary bariatric surgery, with 48.5% undergoing AGB, 27.7% undergoing GBP, and 22.0% undergoing SG. Among patients receiving antidiabetes treatment at baseline, the antidiabetes treatment discontinuation rate was higher 6 years after bariatric surgery than in controls (-49.9% vs -9.0%, P < .001). In multivariable analysis, the main predictive factors for discontinuation were the following: GBP (odds ratio [OR], 16.7; 95% CI, 13.0-21.4), SG (OR, 7.30; 95% CI, 5.50-9.50), and AGB (OR, 4.30; 95% CI, 3.30-5.60) compared with no bariatric surgery, as well as insulin use (OR, 0.17; 95% CI, 0.13-0.22), dual therapy without insulin (OR, 0.38; 95% CI, 0.32-0.45) vs monotherapy, lipid-lowering treatment (OR, 0.76; 95% CI, 0.63-0.91), antidepressant treatment (OR, 0.67; 95% CI, 0.55-0.81), and age (OR, 0.96; 95% CI, 0.95-0.97) per year. For patients without antidiabetes treatment at baseline, the 6-year antidiabetes treatment initiation rate was much lower after bariatric surgery than in controls (1.4% vs 12.0%, P < .001). In multivariable analysis, protective factors were GBP (OR, 0.06; 95% CI, 0.04-0.09), SG (OR, 0.08; 95% CI, 0.06-0.11), and AGB (OR, 0.16; 95% CI, 0.14-0.20) vs controls, and risk factors were as follows: body mass index category (OR, 2.04; 95% CI, 1.68-2.47 for ≥50.0 vs 30.0-39.9 and OR, 1.68; 95% CI, 1.49-1.90 for 40.0-49.9 vs 30.0-39.9), antihypertensive treatment (OR, 1.49; 95% CI, 1.33-1.67), low income (OR, 1.43; 95 % CI, 1.26-1.62), and age (OR, 1.04; 95 % CI, 1.03-1.05) per year. CONCLUSIONS AND RELEVANCE Bariatric surgery was associated with a significantly higher 6-year postoperative antidiabetes treatment discontinuation rate compared with baseline and with an obese control group without bariatric surgery.
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Efficacy of enteral nutritional support after hospital discharge in major gastrointestinal surgery patients: a systematic review.
Vidal Casariego, A, Calleja Fernández, A, Villar Taibo, R, Urioste Fondo, A, Pintor de la Maza, B, Hernández Moreno, A, Cano Rodríguez, I, Ballesteros Pomar, MD
Nutricion hospitalaria. 2017;(3):719-726
Abstract
INTRODUCTION Nutritional support for malnourished patients undergoing gastrointestinal surgery reduces the complication rate and shortens the length of stay. The efficacy of nutritional support after hospital discharge was analyzed in this systematic review. METHODS The search strategy (nutrition OR "enteral nutrition" OR "nutritional supplements" OR "oral nutritional supplements" OR "sip feed" OR "sip feeding" OR "dietary counseling") AND ("patient discharge" OR discharge OR postdischarge) AND (surgery OR operation OR "surgical procedure") was followed in Medline, CENTRAL, and Trip databases. Inclusion criteria comprised: type of study (randomized controlled trial), language (English, Spanish), and subjects (patients undergoing gastrointestinal surgery). The risk of bias was assessed by using the Cochrane methodology. RESULTS Five studies which were published in six different articles and recruited 446 patients were included. A high risk of bias was detected for most of them. Nutritional support improved energy intake and protein intake when high-protein oral supplements were provided. The intervention was associated with better weight prognosis, but the data about body composition were inconsistent. In most of the trials, nutritional intervention did not enhance functional capacity or quality of life. None of the studies analyzed the effects on complications after discharge. CONCLUSION Nutritional support provided at discharge may increase dietary intake and improve body weight, but the low quality of studies can weaken the validity of results.
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Unfavourable risk factor control after coronary events in routine clinical practice.
Sverre, E, Peersen, K, Husebye, E, Gjertsen, E, Gullestad, L, Moum, T, Otterstad, JE, Dammen, T, Munkhaugen, J
BMC cardiovascular disorders. 2017;(1):40
Abstract
BACKGROUND Risk factor control after a coronary event in a recent European multi-centre study was inadequate. Patient selection from academic centres and low participation rate, however, may underscore failing risk factor control in routine clinical practice. Improved understanding of the patient factors that influence risk factor control is needed to improve secondary preventive strategies. The objective of the present paper was to determine control of the major risk factors in a coronary population from routine clinical practice, and how risk factor control was influenced by the study factors age, gender, number of coronary events, and time since the index event. METHODS A cross-sectional study determined risk factor control and its association with study factors in 1127 patients (83% participated) aged 18-80 years with acute myocardial infarction and/or revascularization identified from medical records. Study data were collected from a self-report questionnaire, clinical examination, and blood samples after 2-36 months (median 16) follow-up. RESULTS Twenty-one percent were current smokers at follow-up. Of those smoking at the index event 56% continued smoking. Obesity was found in 34%, and 60% were physically inactive. Although 93% were taking blood-pressure lowering agents and statins, 46% were still hypertensive and 57% had LDL cholesterol >1.8 mmol/L at follow-up. Suboptimal control of diabetes was found in 59%. The patients failed on average to control three of the six major risk factors, and patients with >1 coronary events (p < 0.001) showed the poorest overall control. A linear increase in smoking (p < 0.01) and obesity (p < 0.05) with increasing time since the event was observed. CONCLUSIONS The majority of coronary patients in a representative Norwegian population did not achieve risk factor control, and the poorest overall control was found in patients with several coronary events. New strategies for secondary prevention are clearly needed to improve risk factor control. Even modest advances will provide major health benefits. TRIAL REGISTRATION Registered at ClinicalTrials.gov (ID NCT02309255 ).
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Does Prolonged Enteral Feeding With Supplemental Omega-3 Fatty Acids Impact on Recovery Post-esophagectomy: Results of a Randomized Double-Blind Trial.
Healy, LA, Ryan, A, Doyle, SL, Ní Bhuachalla, ÉB, Cushen, S, Segurado, R, Murphy, T, Ravi, N, Donohoe, CL, Reynolds, JV
Annals of surgery. 2017;(5):720-728
Abstract
OBJECTIVE This randomized controlled trial (RCT) hypothesized that prolonged enteral nutrition (EN) with supplemental eicosapentanoic acid (EPA), an omega-3 fatty acid with immune and anabolic properties, may impact on clinical and nutritional outcomes. BACKGROUND Esophagectomy is associated with significant weight loss and catabolism, and negatively impacts quality of life (QL). Strategies to counter sustained catabolism have therapeutic rationale. METHODS This multicenter, double-blind, placebo-controlled RCT was powered on a 5% difference in lean body mass (LBM) at 1 month. Patients were randomly assigned to receive either EN-EPA (2.2 g EPA/day) (n = 97) or isocaloric isonitrogenous standard EN (EN-S) (n = 94), preoperatively (5 days orally), and postoperatively via a jejunostomy until 1 month postdischarge. Assessments perioperatively, and at 1, 3, and 6 months included weight, body mass index (BMI), body composition, muscle strength, cytokines, complications, and QL. RESULTS The median (range) nutrition support was for 51 (36 to 78) days, and overall compliance was 96%. For the entire cohort, a significant (P < 0.005) decrease in weight (-7.4 ± 6.6 kg), BMI (-2.6 ± 2.2 kg/m), LBM (-2.5 ± 8.7 kg), and fat mass (-3.4 ± 5.8 kg) was evident from preoperatively to 6 months. The mean (±SD) loss of LBM (kg) at 1 month was -3.7 ± 8.7 in the EN-S group, compared with -5.6 ± 12.1 in the EN-EPA group (P = 0.355). Per-protocol analysis revealed no difference between the EN-EPA and EN-S in any clinical, nutritional, functional, QL or immune parameter at any time point. CONCLUSIONS The thesis that EPA impacts on anabolism, immune function, and clinical outcomes post-esophagectomy was not supported. Compliance with home EN was excellent, but weight, muscle, and fat loss was significant in 30% of patients, highlighting the complexity of postoperative weight loss.