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OBJECTIVE: The goal of the current study was to investigate the perioperative outcomes of robotic pancreaticoduodenectomy (RPD) and open pancreaticoduodenectomy (OPD) in a high-volume center. BACKGROUND: Despite RPDs prospective advantages over OPD, current evidence comparing the 2 has been limited and has prompted further investigation. The aim of this study was to compare both approaches while including the learning curve phase for RPD. METHODS: A 1:1 propensity score-matched analysis of a prospective database of RPD with OPD (2017-2022) at a high-volume center was performed. The main outcomes were overall- and pancreas-specific complications. RESULTS: Of 375 patients who underwent PD (OPD n=276; RPD n=99), 180 were included in propensity score-matched analysis (90 per group). RPD was associated with less blood loss [500 (300-800) vs 750 (400-1000) mL; P =0.006] and more patients without a complication (50% vs 19%; P <0.001). Operative time was longer [453 (408-529) vs 306 (247-362) min; P <0.001]; in patients with ductal adenocarcinoma, fewer lymph nodes were harvested [24 (18-27) vs 33 (27-39); P <0.001] with RPD versus OPD. There were no significant differences for major complications (38% vs 47%; P =0.291), reoperation rate (14% vs 10%; P =0.495), postoperative pancreatic fistula (21% vs 23%; P =0.858), and patients with the textbook outcome (62% vs 55%; P =0.452). CONCLUSIONS: Including the learning phase, RPD can be safely implemented in high-volume settings and shows potential for improved perioperative outcomes versus OPD. Pancreas-specific morbidity was unaffected by the robotic approach. Randomized trials with specifically trained pancreatic surgeons and expanded indications for the robotic approach are needed.
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Laparoscopía , Neoplasias Pancreáticas , Procedimientos Quirúrgicos Robotizados , Humanos , Pancreaticoduodenectomía/efectos adversos , Procedimientos Quirúrgicos Robotizados/efectos adversos , Puntaje de Propensión , Páncreas/cirugía , Complicaciones Posoperatorias/etiología , Curva de Aprendizaje , Estudios Retrospectivos , Neoplasias Pancreáticas/cirugía , Neoplasias Pancreáticas/complicaciones , Laparoscopía/efectos adversosRESUMEN
OBJECTIVE: To provide a composite endpoint in pancreatic surgery. SUMMARY BACKGROUND DATA: Single endpoints in prospective and randomized studies have become impractical due to their low frequency and the marginal benefit of new interventions. METHODS: Data from prospective studies were used to develop (n=1273) and validate (n=544) a composite endpoint based on postoperative pancreatic fistula, post-pancreatectomy hemorrhage as well as reoperation and reinterventions. All patients had pancreatectomies of different extents. The association of the developed PAncreatic surgery Composite Endpoint (PACE) with prolonged length of hospital stay (LOS) >75th percentile and mortality was assessed. A single-institution database was used for external validation (n = 2666). Sample size calculations were made for single outcomes and the composite endpoint. RESULTS: In the internal validation cohort, the PACE demonstrated an AUC of 78.0%, a sensitivity of 90.4% and a specificity of 67.6% in predicting a prolonged LOS. In the external cohort, the AUC was 76.9%, the sensitivity 73.8% and the specificity 80.1%. The 90-day mortality rate was significantly different for patients with a positive versus a negative PACE both in the development and internal validation cohort (5.1% vs 0.9%; P< 0.001), as well as in the external validation cohort (8.5% vs 1.2%, P< 0.001). The PACE enabled sample size reductions of up to 80.5% compared to single outcomes. CONCLUSION: The PACE performed well in predicting prolonged hospital stays and can be used as a standardized and clinically relevant endpoint for future prospective trials enabling lower sample sizes and therefore improved feasibility compared to single outcome parameters.
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BACKGROUND: After esophagectomy, the postoperative rate of anastomotic leakage is up to 30% and is the main driver of postoperative morbidity. Contemporary management includes endoluminal vacuum sponge therapy (EndoVAC) with good success rates. Vacuum therapy improves tissue perfusion in superficial wounds, but this has not been shown for gastric conduits. This study aimed to assess gastric conduit perfusion with EndoVAC in a porcine model for esophagectomy. MATERIAL AND METHODS: A porcine model (n = 18) was used with gastric conduit formation and induction of ischemia at the cranial end of the gastric conduit with measurement of tissue perfusion over time. In three experimental groups EndoVAC therapy was then used in the gastric conduit (- 40, - 125, and - 200 mmHg). Changes in tissue perfusion and tissue edema were assessed using hyperspectral imaging. The study was approved by local authorities (Project License G-333/19, G-67/22). RESULTS: Induction of ischemia led to significant reduction of tissue oxygenation from 65.1 ± 2.5% to 44.7 ± 5.5% (p < 0.01). After EndoVAC therapy with - 125 mmHg a significant increase in tissue oxygenation to 61.9 ± 5.5% was seen after 60 min and stayed stable after 120 min (62.9 ± 9.4%, p < 0.01 vs tissue ischemia). A similar improvement was seen with EndoVAC therapy at - 200 mmHg. A nonsignificant increase in oxygenation levels was also seen after therapy with - 40 mmHg, from 46.3 ± 3.4% to 52.5 ± 4.3% and 53.9 ± 8.1% after 60 and 120 min respectively (p > 0.05). An increase in tissue edema was observed after 60 and 120 min of EndoVAC therapy with - 200 mmHg but not with - 40 and - 125 mmHg. CONCLUSIONS: EndoVAC therapy with a pressure of - 125 mmHg significantly increased tissue perfusion of ischemic gastric conduit. With better understanding of underlying physiology the optimal use of EndoVAC therapy can be determined including a possible preemptive use for gastric conduits with impaired arterial perfusion or venous congestion.
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Neoplasias Esofágicas , Esofagectomía , Porcinos , Animales , Esofagectomía/efectos adversos , Esofagectomía/métodos , Anastomosis Quirúrgica/métodos , Estómago/cirugía , Fuga Anastomótica/cirugía , Isquemia/cirugía , Perfusión , Edema/cirugía , Neoplasias Esofágicas/cirugíaRESUMEN
OBJECTIVE: Evaluation of the benefits of a virtual reality (VR) environment with a head-mounted display (HMD) for decision-making in liver surgery. BACKGROUND: Training in liver surgery involves appraising radiologic images and considering the patient's clinical information. Accurate assessment of 2D-tomography images is complex and requires considerable experience, and often the images are divorced from the clinical information. We present a comprehensive and interactive tool for visualizing operation planning data in a VR environment using a head-mounted-display and compare it to 3D visualization and 2D-tomography. METHODS: Ninety medical students were randomized into three groups (1:1:1 ratio). All participants analyzed three liver surgery patient cases with increasing difficulty. The cases were analyzed using 2D-tomography data (group "2D"), a 3D visualization on a 2D display (group "3D") or within a VR environment (group "VR"). The VR environment was displayed using the "Oculus Rift ™" HMD technology. Participants answered 11 questions on anatomy, tumor involvement and surgical decision-making and 18 evaluative questions (Likert scale). RESULTS: Sum of correct answers were significantly higher in the 3D (7.1 ± 1.4, p < 0.001) and VR (7.1 ± 1.4, p < 0.001) groups than the 2D group (5.4 ± 1.4) while there was no difference between 3D and VR (p = 0.987). Times to answer in the 3D (6:44 ± 02:22 min, p < 0.001) and VR (6:24 ± 02:43 min, p < 0.001) groups were significantly faster than the 2D group (09:13 ± 03:10 min) while there was no difference between 3D and VR (p = 0.419). The VR environment was evaluated as most useful for identification of anatomic anomalies, risk and target structures and for the transfer of anatomical and pathological information to the intraoperative situation in the questionnaire. CONCLUSIONS: A VR environment with 3D visualization using a HMD is useful as a surgical training tool to accurately and quickly determine liver anatomy and tumor involvement in surgery.
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Imagenología Tridimensional , Tomografía Computarizada por Rayos X , Realidad Virtual , Humanos , Tomografía Computarizada por Rayos X/métodos , Femenino , Masculino , Hepatectomía/métodos , Hepatectomía/educación , Adulto , Adulto Joven , Toma de Decisiones Clínicas , Interfaz Usuario-Computador , Neoplasias Hepáticas/cirugía , Neoplasias Hepáticas/diagnóstico por imagenRESUMEN
BACKGROUND: The learning curve in minimally invasive surgery (MIS) is lengthened compared to open surgery. It has been reported that structured feedback and training in teams of two trainees improves MIS training and MIS performance. Annotation of surgical images and videos may prove beneficial for surgical training. This study investigated whether structured feedback and video debriefing, including annotation of critical view of safety (CVS), have beneficial learning effects in a predefined, multi-modal MIS training curriculum in teams of two trainees. METHODS: This randomized-controlled single-center study included medical students without MIS experience (n = 80). The participants first completed a standardized and structured multi-modal MIS training curriculum. They were then randomly divided into two groups (n = 40 each), and four laparoscopic cholecystectomies (LCs) were performed on ex-vivo porcine livers each. Students in the intervention group received structured feedback after each LC, consisting of LC performance evaluations through tutor-trainee joint video debriefing and CVS video annotation. Performance was evaluated using global and LC-specific Objective Structured Assessments of Technical Skills (OSATS) and Global Operative Assessment of Laparoscopic Skills (GOALS) scores. RESULTS: The participants in the intervention group had higher global and LC-specific OSATS as well as global and LC-specific GOALS scores than the participants in the control group (25.5 ± 7.3 vs. 23.4 ± 5.1, p = 0.003; 47.6 ± 12.9 vs. 36 ± 12.8, p < 0.001; 17.5 ± 4.4 vs. 16 ± 3.8, p < 0.001; 6.6 ± 2.3 vs. 5.9 ± 2.1, p = 0.005). The intervention group achieved CVS more often than the control group (1. LC: 20 vs. 10 participants, p = 0.037, 2. LC: 24 vs. 8, p = 0.001, 3. LC: 31 vs. 8, p < 0.001, 4. LC: 31 vs. 10, p < 0.001). CONCLUSIONS: Structured feedback and video debriefing with CVS annotation improves CVS achievement and ex-vivo porcine LC training performance based on OSATS and GOALS scores.
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Colecistectomía Laparoscópica , Competencia Clínica , Grabación en Video , Colecistectomía Laparoscópica/educación , Humanos , Porcinos , Animales , Femenino , Masculino , Curva de Aprendizaje , Curriculum , Adulto , Estudiantes de Medicina , Retroalimentación Formativa , Adulto Joven , RetroalimentaciónRESUMEN
BACKGROUND: Image-guidance promises to make complex situations in liver interventions safer. Clinical success is limited by intraoperative organ motion due to ventilation and surgical manipulation. The aim was to assess influence of different ventilatory and operative states on liver motion in an experimental model. METHODS: Liver motion due to ventilation (expiration, middle, and full inspiration) and operative state (native, laparotomy, and pneumoperitoneum) was assessed in a live porcine model (n = 10). Computed tomography (CT)-scans were taken for each pig for each possible combination of factors. Liver motion was measured by the vectors between predefined landmarks along the hepatic vein tree between CT scans after image segmentation. RESULTS: Liver position changed significantly with ventilation. Peripheral regions of the liver showed significantly higher motion (maximal Euclidean motion 17.9 ± 2.7 mm) than central regions (maximal Euclidean motion 12.6 ± 2.1 mm, p < 0.001) across all operative states. The total average motion measured 11.6 ± 0.7 mm (p < 0.001). Between the operative states, the position of the liver changed the most from native state to pneumoperitoneum (14.6 ± 0.9 mm, p < 0.001). From native state to laparotomy comparatively, the displacement averaged 9.8 ± 1.2 mm (p < 0.001). With pneumoperitoneum, the breath-dependent liver motion was significantly reduced when compared to other modalities. Liver motion due to ventilation was 7.7 ± 0.6 mm during pneumoperitoneum, 13.9 ± 1.1 mm with laparotomy, and 13.5 ± 1.4 mm in the native state (p < 0.001 in all cases). CONCLUSIONS: Ventilation and application of pneumoperitoneum caused significant changes in liver position. Liver motion was reduced but clearly measurable during pneumoperitoneum. Intraoperative guidance/navigation systems should therefore account for ventilation and intraoperative changes of liver position and peripheral deformation.
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Movimientos de los Órganos , Neumoperitoneo , Porcinos , Animales , Neumoperitoneo/diagnóstico por imagen , Neumoperitoneo/etiología , Laparotomía , Hígado/diagnóstico por imagen , Hígado/cirugía , RespiraciónRESUMEN
INTRODUCTION: The learning curve in minimally invasive surgery (MIS) is steep compared to open surgery. One of the reasons is that training in the operating room in MIS is mainly limited to verbal instructions. The iSurgeon telestration device with augmented reality (AR) enables visual instructions, guidance, and feedback during MIS. This study aims to compare the effects of the iSurgeon on the training of novices performing repeated laparoscopic cholecystectomy (LC) on a porcine liver compared to traditional verbal instruction methods. METHODS: Forty medical students were randomized into the iSurgeon and the control group. The iSurgeon group performed 10 LCs receiving interactive visual guidance. The control group performed 10 LCs receiving conventional verbal guidance. The performance assessment using Objective Structured Assessments of Technical Skills (OSATS) and Global Operative Assessment of Laparoscopic Skills (GOALS) scores, the total operating time, and complications were compared between the two groups. RESULTS: The iSurgeon group performed LCs significantly better (global GOALS 17.3 ± 2.6 vs. 16 ± 2.6, p ≤ 0.001, LC specific GOALS 7 ± 2 vs. 5.9 ± 2.1, p ≤ 0.001, global OSATS 25.3 ± 4.3 vs. 23.5 ± 3.9, p ≤ 0.001, LC specific OSATS scores 50.8 ± 11.1 vs. 41.2 ± 9.4, p ≤ 0.001) compared to the control group. The iSurgeon group had significantly fewer intraoperative complications in total (2.7 ± 2.0 vs. 3.6 ± 2.0, p ≤ 0.001) than the control group. There was no difference in operating time (79.6 ± 25.7 vs. 84.5 ± 33.2 min, p = 0.087). CONCLUSION: Visual guidance using the telestration device with AR, iSurgeon, improves performance and lowers the complication rates in LCs in novices compared to conventional verbal expert guidance.
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Realidad Aumentada , Colecistectomía Laparoscópica , Laparoscopía , Humanos , Porcinos , Animales , Colecistectomía Laparoscópica/educación , Competencia Clínica , Laparoscopía/educación , CurriculumRESUMEN
Surgical navigation, also referred to as computer-assisted or image-guided surgery, is a technique that employs a variety of methods - such as 3D imaging, tracking systems, specialised software, and robotics to support surgeons during surgical interventions. These emerging technologies aim not only to enhance the accuracy and precision of surgical procedures, but also to enable less invasive approaches, with the objective of reducing complications and improving operative outcomes for patients. By harnessing the integration of emerging digital technologies, surgical navigation holds the promise of assisting complex procedures across various medical disciplines. In recent years, the field of surgical navigation has witnessed significant advances. Abdominal surgical navigation, particularly endoscopy, laparoscopic, and robot-assisted surgery, is currently undergoing a phase of rapid evolution. Emphases include image-guided navigation, instrument tracking, and the potential integration of augmented and mixed reality (AR, MR). This article will comprehensively delve into the latest developments in surgical navigation, spanning state-of-the-art intraoperative technologies like hyperspectral and fluorescent imaging, to the integration of preoperative radiological imaging within the intraoperative setting.
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BACKGROUND: Virtual reality (VR) with head-mounted displays (HMD) may improve medical training and patient care by improving display and integration of different types of information. The aim of this study was to evaluate among different healthcare professions the potential of an interactive and immersive VR environment for liver surgery that integrates all relevant patient data from different sources needed for planning and training of procedures. METHODS: 3D-models of the liver, other abdominal organs, vessels, and tumors of a sample patient with multiple hepatic masses were created. 3D-models, clinical patient data, and other imaging data were visualized in a dedicated VR environment with an HMD (IMHOTEP). Users could interact with the data using head movements and a computer mouse. Structures of interest could be selected and viewed individually or grouped. IMHOTEP was evaluated in the context of preoperative planning and training of liver surgery and for the potential of broader surgical application. A standardized questionnaire was voluntarily answered by four groups (students, nurses, resident and attending surgeons). RESULTS: In the evaluation by 158 participants (57 medical students, 35 resident surgeons, 13 attending surgeons and 53 nurses), 89.9% found the VR system agreeable to work with. Participants generally agreed that complex cases in particular could be assessed better (94.3%) and faster (84.8%) with VR than with traditional 2D display methods. The highest potential was seen in student training (87.3%), resident training (84.6%), and clinical routine use (80.3%). Least potential was seen in nursing training (54.8%). CONCLUSIONS: The present study demonstrates that using VR with HMD to integrate all available patient data for the preoperative planning of hepatic resections is a viable concept. VR with HMD promises great potential to improve medical training and operation planning and thereby to achieve improvement in patient care.
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Cirujanos , Realidad Virtual , Humanos , Hígado , Interfaz Usuario-ComputadorRESUMEN
BACKGROUND: Hepatectomy, living donor liver transplantations and other major hepatic interventions rely on precise calculation of the total, remnant and graft liver volume. However, liver volume might differ between the pre- and intraoperative situation. To model liver volume changes and develop and validate such pre- and intraoperative assistance systems, exact information about the influence of lung ventilation and intraoperative surgical state on liver volume is essential. METHODS: This study assessed the effects of respiratory phase, pneumoperitoneum for laparoscopy, and laparotomy on liver volume in a live porcine model. Nine CT scans were conducted per pig (N = 10), each for all possible combinations of the three operative (native, pneumoperitoneum and laparotomy) and respiratory states (expiration, middle inspiration and deep inspiration). Manual segmentations of the liver were generated and converted to a mesh model, and the corresponding liver volumes were calculated. RESULTS: With pneumoperitoneum the liver volume decreased on average by 13.2% (112.7 ml ± 63.8 ml, p < 0.0001) and after laparotomy by 7.3% (62.0 ml ± 65.7 ml, p = 0.0001) compared to native state. From expiration to middle inspiration the liver volume increased on average by 4.1% (31.1 ml ± 55.8 ml, p = 0.166) and from expiration to deep inspiration by 7.2% (54.7 ml ± 51.8 ml, p = 0.007). CONCLUSIONS: Considerable changes in liver volume change were caused by pneumoperitoneum, laparotomy and respiration. These findings provide knowledge for the refinement of available preoperative simulation and operation planning and help to adjust preoperative imaging parameters to best suit the intraoperative situation.
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Laparoscopía , Trasplante de Hígado , Animales , Hepatectomía , Humanos , Imagenología Tridimensional , Laparotomía , Hígado/diagnóstico por imagen , Hígado/cirugía , Donadores Vivos , PorcinosRESUMEN
At the beginning of the COVID-19 pandemic, it was assumed that SARS-CoV-2 could be transmitted through surgical smoke generated by electrocauterization. Minimally invasive surgery (MIS) was targeted due to potentially higher concentrations of the SARS-CoV-2 particles in the pneumoperitoneum. Some surgical societies even recommended open surgery instead of MIS to prevent the potential spread of SARS-CoV-2 from the pneumoperitoneum. This study aimed to detect SARS-CoV-2 in surgical smoke during open and MIS. Patients with SARS-CoV-2 infection who underwent open surgery or MIS at Heidelberg University Hospital were included in the study. A control group of patients without SARS-CoV-2 infection undergoing MIS or open surgery was included for comparison. The trial was approved by the Ethics Committee of Heidelberg University Medical School (S-098/2021). The following samples were collected: nasopharyngeal and intraabdominal swabs, blood, urine, surgical smoke, and air samples from the operating room. An SKC BioSampler was used to sample the surgical smoke from the pneumoperitoneum during MIS and the approximate surgical field during open surgery in 15 ml of sterilized phosphate-buffered saline. An RT-PCR test was performed on all collected samples to detect SARS-CoV-2 viral particles. Twelve patients with proven SARS-CoV-2 infection underwent open abdominal surgery. Two SARS-CoV-2-positive patients underwent an MIS procedure. The control group included 24 patients: 12 underwent open surgery and 12 MIS. One intraabdominal swab in a patient with SARS-CoV-2 infection was positive for SARS-CoV-2. However, during both open surgery and MIS, none of the surgical smoke samples showed any detectable viral particles of SARS-CoV-2. The air samples collected at the end of the surgical procedure showed no viral particles of SARS-CoV-2. Major complications (CD ≥ IIIa) were more often observed in SARS-CoV-2 positive patients (10 vs. 4, p = 0.001). This study showed no detectable viral particles of SARS-CoV-2 in surgical smoke sampled during MIS and open surgery. Thus, the discussed risk of transmission of SARS-CoV-2 via surgical smoke could not be confirmed in the present study.
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COVID-19 , Neumoperitoneo , Humanos , Pandemias/prevención & control , Estudios Prospectivos , SARS-CoV-2 , Humo , Carga ViralRESUMEN
PURPOSE: As human failure has been shown to be one primary cause for post-operative death, surgical training is of the utmost socioeconomic importance. In this context, the concept of surgical telestration has been introduced to enable experienced surgeons to efficiently and effectively mentor trainees in an intuitive way. While previous approaches to telestration have concentrated on overlaying drawings on surgical videos, we explore the augmented reality (AR) visualization of surgical hands to imitate the direct interaction with the situs. METHODS: We present a real-time hand tracking pipeline specifically designed for the application of surgical telestration. It comprises three modules, dedicated to (1) the coarse localization of the expert's hand and the subsequent (2) segmentation of the hand for AR visualization in the field of view of the trainee and (3) regression of keypoints making up the hand's skeleton. The semantic representation is obtained to offer the ability for structured reporting of the motions performed as part of the teaching. RESULTS: According to a comprehensive validation based on a large data set comprising more than 14,000 annotated images with varying application-relevant conditions, our algorithm enables real-time hand tracking and is sufficiently accurate for the task of surgical telestration. In a retrospective validation study, a mean detection accuracy of 98%, a mean keypoint regression accuracy of 10.0 px and a mean Dice Similarity Coefficient of 0.95 were achieved. In a prospective validation study, it showed uncompromised performance when the sensor, operator or gesture varied. CONCLUSION: Due to its high accuracy and fast inference time, our neural network-based approach to hand tracking is well suited for an AR approach to surgical telestration. Future work should be directed to evaluating the clinical value of the approach.
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Algoritmos , Realidad Aumentada , Mano/cirugía , Humanos , Redes Neurales de la Computación , Estudios RetrospectivosRESUMEN
BACKGROUND: This study aimed to evaluate changes in body tissue composition with obesity surgery regarding visceral fat, subcutaneous fat, and skeletal muscle. DESIGN: Prospective non-randomized single-center cohort study METHODS: Whole-body magnetic resonance imaging (MRI) measured volumes of subcutaneous adipose tissue (SAT), visceral adipose tissue (VAT), and skeletal muscle (SM) in 31 patients with laparoscopic sleeve gastrectomy (LSG, 20) or Roux-en-Y gastric bypass (RYGB, 11) preoperatively, at three- and 12-months follow-up. RESULTS: Body mass index (BMI) went down from 45.2 ± 6.5 preoperatively to 37.2 ± 5.6 (p < 0.001) at three months and 32.2 ± 5.3 kg/m2 (p < 0.001) at 12 months. SAT went down from 55.0 ± 14.0 L (liter) to 42.2 ± 13.3 L (p < 0.001) at three months and 31.7 ± 10.5 L (p < 0.001) at 12 months (- 42.3%). VAT went down from 6.5 ± 2.3 to 4.5 ± 1.7 (p < 0.001) at three months and 3.1 ± 1.7 L (p < 0.001) at 12 months (- 52.3%). SM went down from 22.7 ± 4.8 to 20.4 ± 3.6 (p = 0.008) at three months and remained 20.2 ± 4.6 L at 12 months (p = 0.17 relative three-month; p = 0.04 relative preop, - 11.1%). Relative loss was higher for VAT than that for SAT (52.3 ± 18.2% vs. 42.3 ± 13.8%; p = 0.03). At 12 months, there was no difference between LSG and RYGB for relative changes in BMI or body tissue composition. CONCLUSION: Postoperatively, there was higher net loss of SAT but higher relative loss of VAT with weight loss. SM was lost only during the first three months. MRI provides accurate evaluation of surgeries' effect on individual patients' tissue composition. This can benefit risk assessment for related cardiovascular and metabolic health but cost-related factors will likely reserve the used methods for research.