Restrictive Procedures Research Articles

Investigating the Results of One Anastomosis Gastric Bypass After Primary Metabolic and Bariatric Restrictive Procedures.

Previous studies showed a high conversion rate and failure of restrictive procedures, including sleeve gastrectomy (SG), adjustable gastric banding (AGB), gastric plication (GP), and vertical banded gastroplasty (VBG) in a long-term follow-up. The current study aims to evaluate the efficacy and safety of a revisional one anastomosis gastric bypass (OAGB) for weight loss and treatment of obesity-related problems after primary metabolic and bariatric restrictive procedures. A retrospective study on prospectively collected data was conducted on a sample of 151 patients who experienced insufficient weight loss or weight regain after primary restrictive surgeries and underwent OAGB as a revisional procedure. A total of 151 patients with a history of previous restrictive metabolic and bariatric surgery who underwent a revisional OAGB were included in this study. The restrictive procedures consisted of SG (n = 79), AGB (n = 45), GP (n = 15), and VBG (n = 12). Total weight loss percent (%TWL) after the revisional OAGB was 27.03 ± 9.12, 27.74 ± 10.05, 24.62 ± 9.87, and 24.34 ± 8.05 after 12, 24, 60, and 84 months, respectively. After 24 months of follow-up, TWL was significantly higher in the GP group compared to the AGB group. However, weight loss outcomes were not significantly different after 60 months of follow-up. The revisional OAGB was associated with a significant resolution of obesity-related problems, including type 2 diabetes (55.55%), hypertension (50%), dyslipidemia (77%), and obstructive sleep apnea (100%) after 2 years of follow-up. There was no serious complication after the revisional OAGB in the short- and long-term follow-up. OAGB is an efficient and safe option as a conversion surgery after restrictive procedures.

Living conditions in Italian administrative detention centres for migrants: a scoping review

Abstract Since 2011, Italy has experienced a growing flow of migrants, despite the implementation of restrictive and detention-oriented procedures. Detention facilities for migrants must provide health protection and general assistance to the person. Considering the critical state of the centres reported by various sources, this study gives an overview of the conditions in Italian detention facilities for migrants from a public health perspective. A scoping search of the peer-reviewed and grey literature was performed to investigate the public health standards currently in force in Italian detention facilities for migrants and refugees (Hotspot and CPR-Pre-removal Detention Centres). Articles published from 2009 to 2021 in English and Italian were included and qualitatively described in five categories: provision of healthcare, living conditions, protection of vulnerable detainees, access to legal advice, and the Covid-19 pandemic. 11 peer-reviewed studies and 24 grey documents were included. Guidelines on screening procedures for infectious diseases or vaccines appeared to be hastily followed; chronic and mental diseases were not appropriately addressed. The facilities were described as run-down, with scarce and poor-quality meals, and lacking of educational activities. A lack of protection for vulnerable categories was reported, including unaccompanied minors. The Covid-19 pandemic further exacerbated pre-existing issues, highlighting systemic weaknesses in preparedness and response. Life conditions within the centres for migrants in Italy fall significantly short of acceptable standards. The main problems are the unavailability of cultural mediation services and the insufficient protection of mental health. The overall conditions appeared to be not dignifying and violations of the law are, if not frequent, present and well recognised. Urgent reforms are warranted to address these shortcomings and ensure the humane treatment and protection of migrants within these facilities. Key messages • Italy is responding to the recent inflow of migrants with policies oriented to detention and repatriation. To this, it established de-facto detention centres for migrants, namely Hotspot and CPRs. • The public health standards of migrants’ repatriation centres are poorly followed and life inside the centres appears misereble.

Bone Health Following Sleeve Gastrectomy versus Roux-en-Y Gastric Bypass Surgery

Introduction: Bariatric surgery may have detrimental effects on bone health. We investigated the long-term effects of bariatric surgery on bone health to delineate whether they differed by procedure type. Methods: The records of patients who had undergone either sleeve gastrectomy (SG) or Roux-en-Y Gastric Bypass (RYGB) surgery with a follow up period of 2 years were reviewed. Comparison was made between blood assays (vitamin D, parathormone, calcium, phosphate and magnesium) and aerial bone mineral density (aBMD) measured at baseline with measurements made at 6, 12, 18 and 24 months post-operatively. History of fractures was also recorded. Results: There were 1309 in the SG group and 1132 patients in the RYGB group. There was a gradual decrease in vitamin D, calcium, phosphate and magnesium and increase in parathormone levels peaking at 18 months in both groups (P<0.05). There was also reduction in aBMD over time being greater at 24 months and most marked in the total hip and full body measures (p<0.05). This correlated to amount of weight loss. All changes were more in RYGB (p<0.05) where there was also a higher number of post-operative fractures (p<0.05). Conclusion: Bariatric surgery is associated with gradual decline in bone health and increased fracture risk peaking at 18 months after surgery. This effect is more prominent with RYGB (combined restrictive and malabsorptive) procedures as opposed to SG (restrictive only) surgeries. It is imperative to counsel patients about increased bone fragility and fracture risk prior to making the choice of bariatric surgery.

Laparoscopic Conversion of Gastric Plication to One Anastomosis Gastric Bypass

Laparoscopic gastric plication (LPG) is a restrictive procedure to reduce the size of the stomach by folding and suturing the stomach to decrease its capacity. LGP has a high revision rate, mostly to sleeve gastrectomy. To the best of our knowledge, this is the first such report on the bariatric population that has been never described before.The purpose of this video was to show the feasibility and safety, as well as the main technical aspects, of a laparoscopic conversion of gastric plication to One Anastomosis Gastric Bypass.

Pregnancy Outcomes After Bariatric Surgery: Importance of Maternal Ferritin on Birth Weight.

The risks carried by pregnancy after bariatric surgery (BS) include small-for-gestational age (SGA) newborn and prematurity. However, the underlying mechanisms are not yet fully understood in pregnant women after BS. This single-center retrospective observational cohort study includes all women with a first and single pregnancy after BS who completed at least one clinical and biological nutritional assessment during pregnancy between 2010 and 2016. The quarterly biological assessment comprised blood count, ferritin, calcium, 25OH vitamin D, parathyroid hormone, fasting glucose, albumin, prealbumin, vitamin A, vitamin B12, folic acid, and zinc. Among 120 pregnancies analysed, two-thirds underwent gastric bypass (Roux-en-Y and one-anastomosis) and one-third a restrictive procedure (adjustable gastric band or sleeve gastrectomy). The median [Q1-Q3] preoperative BMI was 43.8 [41.1-47.7] kg/m2 and the mean age at pregnancy was 32.6 ± 5.3years. Weight loss and time from surgery to pregnancy were 35.1 ± 15.4kg and 2.9 [1.3-4.5] years, respectively. Ten women (8%) gave birth prematurely, and 22 newborns (19%) were SGA. Univariate analysis shows that ferritin was significantly higher in mothers with SGA than in those without SGA (35.5 [22.3-69.5] vs. 15 [10-32] ng/ml) at third trimester of pregnancy. Women who received pre-pregnancy nutritional assessment seemed less likely to give birth to a SGA newborn (32% vs. 54%, p = 0.07). Iron supplementation should be carefully prescribed and closely monitored during pregnancy in women who have undergone BS.

Revision of restrictive bariatric procedures in elderly patients: results at a 5-year follow-up

Revisional Bariatric Surgery (RBS) is increasing in popularity. Elderly patients (> 65 years old) are sometimes referred for RBS evaluation. The aim of this study is to evaluate outcomes of elderly patients undergoing RBS. A retrospective analysis of a cohort from a single–tertiary bariatric center. All elderly patients undergoing RBS after restrictive procedures between 2012 and 2022 were included. Thirty Nine patients undergoing RBS were included in the comparative analysis − 23 patients (57.5%) after adjustable gastric banding (s/p LAGB) and 16 patients (40%) after Sleeve Gastrectomy (s/p SG). The mean age and body mass index (BMI) of patients were comparable (67.2 ± 2.8 years and 38.3 ± 7.4, respectively). There was no difference in associated medical problems except reflux which was higher in s/p SG (68% vs. 13%; p < 0.001). The mean time interval between surgeries was 8.7 ± 5.1 years. The surgeries included One anastomosis gastric bypass (n = 22), SG (n = 8) and Roux-en-y gastric bypass (n = 9). Early major complication rates were comparable (4.3% and 12.5%; p = 0.36), and readmission rate was higher in patients s/p SG (p = 0.03). Ninety percent of patients were available to a follow-up of 59.8 months. The mean BMI and total weight loss was 29.2 and 20.3%, respectively with no difference between groups. The rate of patients with associated medical problems at last follow-up was significantly reduced. Five patients (12.5%) underwent revisional surgery due to complications during follow-up. In conclusion, RBS in the elderly is associated with a reasonable complication rate and is effective in terms of weight loss and improvement of associated medical problems in a 5-year follow-up.

The evolution and current state of bariatric endoscopy in Western countries.

With the alarmingly increasing prevalence of obesity in the Western world, it has become necessary to provide more acceptable treatment options for patients with obesity. Minimally invasive endoscopic techniques are continuously evolving. Currently, metabolic and bariatric endoscopies encompass several different techniques that can offer significant weight loss and improvement in comorbidities with a favorable safety profile. Restrictive bariatric procedures include the use of intragastric balloons and gastric remodeling techniques with different suturing devices. Several studies have demonstrated the efficacy and safety of these techniques that are widely used in clinical practice. Small intestine-targeted metabolic endoscopy is an intriguing and rapidly evolving field of research, although it is not widespread in routine practice. These techniques include duodenal-jejunal bypass liners, duodenal mucosal resurfacing, and incisionless anastomoses. The aim of this review article is to provide a detailed update on the currently available bariatric endoscopy techniques in Western countries.

Stopgap Measures for Obesity Prior to Surgery.

The data on preventive measures for managing obesity prior to surgery is limited. This review highlights the role of stopgap measures for managing obesity before surgery. Body weight regulation to achieve sustainable weight loss is a gradual process. Regular aerobic exercises, transformative yoga and restrained eating can contribute to a calorie deficit. Behavioural strategies aim to raise awareness, set goals, manage stress, and support adherence to healthier lifestyles. Pharmacotherapy can be adjunctive in inducing weight loss but could be better at maintaining weight. Intragastric balloon and endoscopic sleeve gastroplasty are restrictive procedures for patients before surgery. Obesity is a multifaceted chronic disease with adverse health consequences. There is a need to identify contributors to weight gain and treatment should target the cause of obesity. Utilize stop-gap measures and monitor progress for step-up or more intensive treatment. Structured weight loss needs lifelong commitment.

Information Sovereignty of the Republic of Belarus and the Russian Federation: Directions for Ensuring and Ways to Improve them

The article discusses the main directions of ensuring information sovereignty in the Republic of Belarus and the Russian Federation, as well as ways to improve them. To date, some problems have been identified that relate to the security of the information sphere of the Russian Federation and the Republic of Belarus, which made it possible to create specific measures to resolve them.Aim. In the information sphere of countries such as the Republic of Belarus and the Russian Federation, various studies of a comprehensive plan were conducted by various scientists, politicians, as well as the military. Thanks to these studies, today there is a theoretical basis for improving the entire mechanism for protecting the information sovereignty of the two countries. However, due to the dynamism of the integration plan processes, changes in globalization, as well as due to the situation in geopolitics, it becomes necessary to conduct more and more analytical studies regarding the application of practical experience in ensuring national security in the information sphere.Tasks. Identification and justification of priority areas for improving the provision of information sovereignty of the Republic of Belarus and the Russian Federation as the basis of the information component.Methods. During the study, standard scientific methods of analysis and synthesis, expert-analytical, structural-logical, comparative and structural-functional methods, as well as a forecasting method were used.Results. The study showed that the information sovereignty of the Republic of Belarus and the Russian Federation ensures their political, economic, social stability and sustainable progressive development, since in the context of the globalization of the information space and key areas of public life, the influence on the information field increases and the importance of information security at the national levels increases for each state.Conclusions. It is expedient to consolidate the equal importance in the composition of the structural mechanisms for ensuring the information sovereignty of the Republic of Belarus and the Russian Federation, their constitutional and legal status and equivalent nature. The use of exclusively control and supervisory, regulatory and restrictive procedures in the information environment is not sufficient to maintain information sovereignty.

Stimulus Avoidance Assessment: A Systematic Literature Review.

Board certified behavior analysts are ethically required to first address destructive behavior using reinforcement-based and other less intrusive procedures before considering the use of restrictive or punishment-based procedures (ethics standard 2.15; Behavior Analyst Certification Board, 2020). However, the inclusion of punishment in reinforcement-based treatments may be warranted in some cases of severe forms of destructive behavior that poses risk of harm to the client or others. In these cases, behavior analysts are required to base the selection of treatment components on empirical assessment results (ethics standard 2.14; Behavior Analyst Certification Board, 2020). One such preintervention assessment is the stimulus avoidance assessment (SAA), which allows clinicians to identify a procedure that is likely to function as a punisher. Since the inception of this assessment approach, no studies have conducted a systematic literature review of published SAA cases. These data may be pertinent to examine the efficacy, generality, and best practices for the SAA. The current review sought to address this gap by synthesizing findings from peer-reviewed published literature including (1) the phenomenology and epidemiology of the population partaking in the SAA; (2) procedural variations of the SAA across studies (e.g., number of series, session length); (3) important quality indicators of the SAA (i.e., procedural integrity, social validity); and (4) how the SAA informed final treatment efficacy. We discuss findings in the context of the clinical use of the SAA and suggest several avenues for future research.

First national analysis of severe obesity hospitalizations in Italy: insights from discharge card database.

Obesity is associated with numerous severe diseases necessitating intensive healthcare for diagnosis and treatment. Most patients with obesity, especially in its severe form, require at least one hospitalization. However, few studies in Italy have assessed the burden of obesity on the National Health System. This study aims to routinely estimate the 'disease burden' by analyzing hospital admissions related to severe obesity. We analyzed the medical records of the Italian national hospital discharge database, including all patients older than 18 years discharged with the diagnosis of 'severe obesity'.' We included patients who underwent bariatric surgery, even without an explicit obesity code, such as laparoscopic restrictive gastric procedures, other stomach operations, and high gastric bypass. Special focus was given to those who underwent abdominal reshaping surgery. The cross-sectional survey PASSI in Italy served as an additional data source to estimate. The phenomenon was described using appropriate indicators, including rates and ratios between rates. Linear regression was employed to analyze trends in standardized rates over time. Between 2014 and 2021, a total of 243,325 patients were discharged with a severe obesity code in Italy. Among these patients, 36.8% underwent at least one bariatric surgery procedure. We investigated the types of bariatric surgery procedures performed. The most frequent procedure was "other operations on the stomach," where sleeve gastrectomy is included which also appears to be steadily increasing during the study period together with the gastric bypass, while the gastric bondage is decreasing over time. These findings underscore the significant burden of severe obesity on Italy's healthcare system, a burden that is progressively increasing. The growing utilization of bariatric surgery suggests an escalating trend toward adopting drastic solutions to combat this health issue.

Roux-en-Y Gastric Bypass after Laparoscopic Sleeve Gastrectomy Failure: Could the Number of Previous Operations Influence the Outcome?

After a failed laparoscopic adjustable gastric band (LAGB), laparoscopic sleeve gastrectomy (LSG) has been proposed as revisional surgery. Those patients that receive a second restrictive procedure fall into a small subgroup of patients with more than one restrictive procedure (MRP). If also the second restrictive procedure fails, the correct surgical strategy is a challenge for the surgeon. Roux-en-Y gastric bypass (RYGB) may be an option but there is no evidence in the literature on whether the procedure is effective in treating failures after MRP. This study aims to evaluate the influence of the previous number of restrictive interventions (MRP vs single LSG) in the results of RYGB as revisional surgery. We have retrospectively analyzed patients who underwent conversion from laparoscopic sleeve gastrectomy (LSG), or from multiple restrictive procedures (MRP), to RYGB for weight regain (WR) or insufficient weight loss (IWL) between 2009 and 2019. The number of patients analyzed was 69 with conversion to RYGB after LSG and 44 after MRP. The reduction of excess weight (%TWL) at 3, 6, 12, 24 RYGB postoperative months was respectively of 11.03%, 16.39%, 21.43%, and 24.22% in the MRP group, and of 10.97%, 16.4%, 21.22%, and 22.71% in the LSG group. No significant difference was found in %TWL terms after RYGB for the MRP group and the LSG group with an overall %TWL, which was 11.00 ± 6.03, 16.40 ± 8.08, 21.30 ± 9.43, and 23.30 ± 9.91 respectively at 3, 6, 12, and 24 months. The linear regression model highlighted a positive relationship between the %EWL post-bypass at 24 months and the time elapsed only between the LSG and RYGB in the MRP group patients (p < 0.001). RYGB has proved to be a reliable technique with good results in terms of weight loss after failed bariatric surgery both in patients who previously underwent MRP and in those who underwent exclusively LSG. RYGB showed better results in patients who experienced WR than in those who had IWL from previous techniques.

Проблемные вопросы, связанные с исполнением уголовных наказаний в отношении иностранных граждан

Foreign citizens who have committed crimes on the territory of Russia are subject to criminal liability on an equal footing with citizens of the Russian Federation. In connection with the fact that for the last three years the number of foreign citizens convicted by Russian courts has significantly increased, the conclusion about the relevance of the study is made. The aim of the study is to identify problematic issues of the enforcement of criminal penalties when establishing the fact of departure of a convicted foreign citizen from the Russian Federation. To reach this aim, the author used statistical, comparative-legal, formal-legal methods of research, a study of documentary sources, a method of interpretation of legal norms and legal forecasting, as well as applied the rules and techniques of formal and dialectical logic. When conducting the study, the author proposes to consider the peculiarities of sentencing, dividing the sentences of Russian courts into two groups: with deprivation of liberty and punishments not related to isolation from society. Thus, in the sphere of penalties in the form of deprivation of liberty there are cases when a convicted foreign citizen can leave the territory of the Russian Federation, since restrictive procedures are not applied to him/her. This occurs when imposing punishment in the absence of the defendant (in absentia) or when a decision is made to independently go to the place of serving the sentence in a settlement colony. At the same time, in the case of establishing the location of such a convicted person in the state of his/her citizenship, the further mechanism of execution of criminal punishment is not clear. Similar problems have been identified in the application to foreign citizens of criminal penalties not related to the isolation of convicted persons from society. Contradictions of legislative norms in various spheres have been revealed, which do not allow the execution of criminal penalties, as a convicted foreign citizen must be deported from Russia. It has been found that in many respects the problem under study is formed by the lack of grounds for extradition of the convicted person, as well as non-recognition of the sentences of the Russian court by the state in the convicted person’s place of citizenship. Based on the results of the study, the author proposes several options for solving the problem under consideration: establishment of an unambiguous ban on the departure from Russia of a convicted foreign citizen until the criminal sentence has been served in full; development of the practice of concluding international treaties (agreements) with foreign states; establishment for foreign citizens of a new type of basic criminal punishment – “forced expulsion from the Russian Federation”; payment of compensation by the state of which the convicted person is a citizen; determination of the possibility to serve the sentence in the state of the foreign citizens location with his/her voluntary consent.

Gastric bypass - 10 years' results.

Gastric bypass has not gained as much popularity in the Czech Republic as technically simpler restrictive bariatric procedures, frequently with a fading long-term effect. The aim of the presentation is to point out the long-term results after two types of gastric bypasses. Retrospective analysis of prospectively collected data in an initial set of patients after laparoscopic RYGB (Roux Y gastric bypass) and OAGB/MGB (one anastomosis/mini gastric bypass) performed at Breclav Hospital in 2010-2013. Evaluation based on the BAROS system, according to weight development, comorbidities, psychological aspects, complications and reoperations. Data available for evaluation are from 32 patients out of a total of 60; the follow-up rate is 53%. The patients are lighter by 34 kg on average (0-64 kg); TBWL (total basic weight loss): 25.7%. The majority of operated diabetics are free of signs of diabetes, and all others have a reduced need for antidiabetic medication. Hypertension, sleep apnea and psychological assessment of life in 6 domains improved. Eight of the 32 followed patients underwent reoperation during 10 years; only 2 of these procedures were acute for complications (anastomotic ulceration), both in smokers; further elective reoperations included 2 conversions of OAGB/MGB to RYGB due to reflux, 2 corrective surgeries, and 2 procedures for a suspected internal hernia. There was no conversion from laparoscopic to open surgery, no peritonitis associated with a leak, and no mortality within 30 days. The BAROS score (5.56) indicates a "very good result" of the gastric bypasses after 10 years. Gastric bypasses are safe and provide a high and lasting metabolic effect that meets the general expectations of an invasive intervention that can fundamentally improve the quality of treatment for otherwise incurable chronic diseases related to adiposity (so-called ABCD), especially type 2 diabetes.

Activation of neurons in the insular cortex and lateral hypothalamus during food anticipatory period caused by food restriction in mice

Mice fed a single meal daily at a fixed time display food anticipatory activity (FAA). It has been reported that the insular cortex (IC) plays an essential role in food anticipation, and lateral hypothalamus (LH) regulates the expression of FAA. However, how these areas contribute to FAA production is still unclear. Thus, we examined the temporal and spatial activation pattern of neurons in the IC and LH during the food anticipation period to determine their role in FAA establishment. We observed an increase of c-Fos-positive neurons in the IC and LH, including orexin neurons of male adult C57BL/6 mice. These neurons were gradually activated from the 1st day to 15th day of restricted feeding. The activation of these brain regions, however, peaked at a distinct point in the food restriction procedure. These results suggest that the IC and LH are differently involved in the neural network for FAA production.

Comparison of Roux-en-Y Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy in Obese Patients with Type 2 Diabetes

BackgroundObesity and type 2 diabetes mellitus (T2DM) are illnesses with high prevalence, morbidity, and health-care costs. It has been shown that bariatric surgery is effective for inducing weight loss and maintaining adequate glucose control. Roux-en-Y gastric bypass (RYGB) and laparoscopic sleeve gastrectomy (LSG), which account for over 80% of surgical methods used globally, are the most frequently performed restrictive or malabsorptive surgical procedures in bariatric surgery. ObjectiveTo assess the efficacy of RYGB versus LSG in terms of weight loss and glycemic control for obese patients with T2DM. MethodsIn 220 patients with T2DM and prediabetes who underwent RYGB and LSG between 2016 and 2021, an observational and retrospective study was conducted. At 6, 12, 24, and 36 months post-surgery, diabetes and loss of weight were assessed. ResultsThe study involved 220 patients, including 102 patients with prediabetes and 118 patients with diabetes. The longer surgery duration in the RYGB (68 vs. 50.2 minutes; p<0.001) was the only perioperative variable with a statistically significant difference. RYGB was associated with excess weight loss. Compared to those who received LSG, diabetic patients who underwent RYGB had a greater level of resolution or control. After 24 months of follow-up in patients with prediabetes, there was remission in both groups. ConclusionIn patients with T2DM and prediabetes, RYGB and LSG had outstanding results in terms of losing weight and glycemic control, but in our patients, RYGB produced better outcomes in both categories.

IBC-Oxford University2023_BJSPoster_7BariClip placement in patient with recurrent hiatal hernia: Is it feasible?

Abstract Obesity is a disease with global distribution that affects a vast majority of the population, it has impact not only in patient’s health but has implications in health systems within the state and country. GERD is highly related with being overweight and obese given that these two pathologies are risk factors for developing GERD and its further complications like Barrett’s oesophagus. There are multiple surgical techniques to treat GERD and obesity, we report the case of a 43-year-old female with reflux symptoms secondary to a recurrent hiatal hernia with a previous laparoscopic Nissen fundoplication. Obesity is a disease with a global distribution, it affects a vast majority of the population leading to a great number of complications not only for the patient but for the states and countries, the prevalence has doubled in the last 30 years, considering this disease as one of the most important risk factors for developing gastroesophageal reflux and Barrett’s oesophagus. It has been proved that being overweight increases 1.2-3 times the risk of GERD and in patients with obesity the prevalence is up to 37-72%. GERD is a disease that commonly affects the general population, it is difficult to establish the incidence, yet it is reported that approximately 42% of the U.S population has symptoms every month and up to 60% has had symptoms at least once in their lifetime. Laparoscopic Gastroplasty with BariClip should be considered as a restrictive procedure given that has demonstrated to have more restriction than the procedures by endoscopic approach, lasting longer and with the advantage that is reversible, clipping and not cutting the stomach, it is as effective as the laparoscopic sleeve gastrectomy surgery, with minimum complications and the possibility of being performed as an outpatient procedure. This is performed placing a non-adjustable clip vertically 3 cm to the lesser curvature of the stomach.

IBC-Oxford University2023_BJSOral_9Calcitonin as a satiety inducer; normalizes in one year after LSG in morbidly obese patients.

Abstract Laparoscopic Sleeve Gastrectomy (LSG) is the commonest bariatric procedure done worldwide for morbid obesity. LSG benefits extend beyond it being just a restrictive procedure. Hormonal effects after LSG are well documented in literature. Calcitonin has been ascribed to induction of satiety in mammals. We studied calcium homeostasis in patients(N=21) suffering with morbid obesity who underwent LSG and compared them with non-obese candidates (N=15) who were age and sex matched. Blood samples were collected from patients on day before LSG (day-0), day-180, and day-360 after LSG. Blood sample was collected from non-obese group for comparison. We found that there was no significant difference of calcium in the patients compared to non-obese candidates. We observed that mean serum vitamin D increased on day-180 (M=55.33nM, SD=34.72, p=0.059) and day-360 (M=58.24nM, SD=36.19, p=0.038) from values on day-0 (M=29.48nM, SD=21.03, p=0.423) compared to non-obese candidates (M=35.4nM, SD=22.36). Decrease in mean parathyroid hormone (PTH) on day-180 (M=4.19pM, SD=1.8, p=0.83) and on day-360 (M=4.9pM, SD=2, p=0.31) from day-0 (M=6.19pM, SD=3.53, p=0.06) was observed, compared to non-obese candidates (M=4.31pM, SD=1.2). However, normalization of mean calcitonin was noted on day-180 (M=0.4pM, SD=0.8, p=0.22) and day-360 (M=0.8pM, SD=1.1, p=0.74) from day-0 (M=0.34pM, SD=0.4, p=0.02) compared to non-obese candidates (M=0.7pM, SD=0.41). Results of this study showed normalization of calcitonin, which may have role in satiety after LSG. Larger study is recommended to ascertain the trend of calcitonin after LSG.

IBC-Oxford University2023_BJSOral_1Dynamic Magnetic Resonance Imaging (Dy-MRI) Evaluation of the Impact of Endoscopic Sleeve Gastroplasty (ESG) on Gastric Structure and Function in Morbid Obese Patients

Abstract Introduction Endoscopic sleeve gastroplasty (ESG) is a restrictive endoluminal bariatric procedure consisting in the application of multiple full-thickness sutures to reduce gastric capacity (GC) and slow down gastric emptying (GE). Although results are promising, a large variation in the weight loss outcomes is reported. Dynamic resonance imaging (Dy-MRI) has been successfully applied for the assessment and analysis of gastrointestinal (GI) function. It permits to acquire large field-of-view, dynamic, high- resolution, three-dimensional (3D) image data with excellent soft-tissue contrast in less than a second3. In addition, our group previously demonstrated a significant correlation between weight loss and gastric anatomy changes assessed by Dy-MRI in laparoscopic sleeve gastrectomy (LSG) patients. The aim of this study is to use Dy-MRI to objectively assess gastric structural and functional changes 6 months after ESG and their impact on weight loss. Material and methods Prospective single centre study. Patients underwent preoperative and postoperative (after 6 months) Dy-MRI to evaluate total GC and GE changes, immediately after the ingestion of 400 ml of liquid meal and over time up to 120 minutes after ingestion (T120). Only patients with a complete follow up at and 6 months (M6) were included. Demographic data, pre- and intra-operative data, and weight loss outcomes were collected. Continuous variables were reported as median and interquartile rank (IQR), while categorical variables as numbers and percentages. Results From July 2021 to June 2023, 16 ESG patients participated in this study. Patients had a median age of 41.5 years (IQR:35-49.7) with a median BMI (kg/m2) of 36.9 (IQR: 34.08-42.18). A median number of 6 (IQR: 5.2-6) purse string sutures were placed during the ESG. There were no complications. At the follow-up gastroscopy at M6 all patients presented an intact ESG with all the suture still present. Dy- MRI showed a median GC reduction of 34.1% of the initial volume (p&amp;lt;0.0001) and GE decreased by 0.43 mL/min (p=0.01). As a whole, the study population had a 16.8% of total weight loss (TWL) at M6 (p&amp;lt;0.0001). Similarly, the median BMI decreased from 36.9 to 29.9 (p=0.01). %TWL varied from 15.5 at M3 to 18.3 at M6. During the same time-elapse, %EWL increased from 46.4 to 57.1. Discussion and Conclusion Dy- MRI is confirmed to be a non-invasive method capable of objectively quantify gastric volume reduction and GE changes after ESG. It is likely that these two factors play a synergic role in the weight loss journey of patients undergoing ESG. Further investigations in a larger sample are needed to support these initial findings and to support an evidence based, patient specific approach to endoscopic gastric remodelling.

Balancing the Objectives of Statistical Efficiency and Allocation Randomness in Randomized Controlled Trials

Various restricted randomization procedures are available to achieve equal (1:1) allocation in a randomized clinical trial. However, for some procedures, there is a nonnegligible probability of imbalance in the final numbers which may result in an underpowered study. It is important to assess such probability at the study planning stage and make adjustments in the design if needed. In this article, we perform a quantitative assessment of the tradeoff between randomness, balance, and power of restricted randomization designs targeting equal allocation. First, we study the small-sample performance of biased coin designs with known asymptotic properties and identify a design with an excellent balance–randomness tradeoff. Second, we investigate the issue of randomization-induced treatment imbalance and the corresponding risk of an underpowered study. We propose two risk mitigation strategies: increasing the total sample size or fine-tuning the biased coin parameter to obtain the least restrictive randomization procedure that attains the target power with a high, user-defined probability for the given sample size. Additionally, we investigate an approach for finding the most balanced design that satisfies a constraint on the chosen measure of randomness. Our proposed methodology is simple and yet generalizable to more complex settings, such as trials with stratified randomization and multi-arm trials with possibly unequal randomization ratios.