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NCT07319390
The aim of this study will be to compare between MTP and ESPB in terms of postoperative pain score in patients undergoing laparoscopic sleeve gastrectomy
NCT07313293
Obesity is a major public health issue. The Obépi epidemiological survey, the results of which were published in 2020, shows a steady increase in obesity among the French population. Currently, more than 23 million French people are overweight or obese, and more than 8 million French people are obese. The most effective treatment currently available is surgery. These procedures are governed by specific recommendations. Between 50,000 and 60,000 procedures are performed in France each year. Three procedures are authorised: gastric banding, sleeve gastrectomy and gastric bypass. Hallyday \& al report 65% of patients experiencing nausea/vomiting after bariatric surgery. In 2019, Suh \& al showed that nausea and vomiting were more common after sleeve gastrectomy and that they were responsible for an increase in the length of hospitalisation. These episodes of nausea and vomiting occur within 48 hours after sleeve gastrectomy and can cause difficulties in resuming eating. One of the factors contributing to the occurrence of nausea and vomiting was the use of opioids. The benefits of foot reflexology were reported in 2023 by Dr Carrazé in rectal surgery. His doctoral thesis in medicine showed that foot reflexology sessions on days 1, 2 and 3 following rectal surgery reduced post-operative ileus and post-operative pain. The reduction in post-operative ileus led to a decrease in episodes of nausea and vomiting. In 2021, Murat-Ringot \& al demonstrated the beneficial effect of foot reflexology on nausea and vomiting during chemotherapy sessions, in addition to the anti-emetic treatments used for prevention. Anderson \& al. in 2021 also demonstrated a beneficial effect on pain in cancer patients, with no effect on nausea. The principle of foot reflexology is based on the fact that each organ, gland or part of the body corresponds to a reflex zone on the foot, hand, ears or face. Stimulation of the reflex zones is thought to activate the autonomic nervous system. Currently, there is very little scientific evidence on how this practice works and what its effects are. Despite various scientific publications on the results of foot reflexology, scientific evidence of its effectiveness remains weak. Only one prospective randomised trial has been found in the literature (Dalal \& al.) on the quality of life of patients with epilepsy. Despite the lack of high-quality studies, it appears that foot reflexology could benefit patients by reducing nausea and vomiting. To date, no studies have evaluated its effectiveness in the post-operative period, particularly after bariatric surgery. The aim of our randomised trial is to evaluate the impact of foot reflexology on nausea and vomiting after sleeve gastrectomy.
NCT07451327
EFFECT OF ADDING MAGNESIUM SULPHATE TO BUPIVACAINE IN LAPAROSCOPIC PERIPORTAL PREPERITONEAL LOCAL INFILTRATION IN LAPAROSCOPIC SLEEVE GASTRECTOMY Our study shows that adding magnesium to the block will prolong duration of analgesia and decrease total amount of analgesia needed will decrease time of stay at PACU and stay at hospital
NCT07230769
Laparoscopic sleeve gastrectomy (LSG) has become an increasingly popular bariatric procedure since its first performance by Hess and Hess in 1988 as a component of the biliopancreatic diversion-duodenal switch (BPD-DS) procedure, which was modified from Scopinaro's biliopancreatic diversion (BPD) and DeMeester's technique. In the early part of the twenty-first century, it was popularized as a first-step intervention before BPD or gastric bypass in the super obese and high-risk group of patients by Regan et al. Due to the unexpected good results in terms of weight loss and resolution of comorbidities, coupled with the simplicity of performing the procedure requiring intervention on only the stomach, sleeve gastrectomy gained status as a stand-alone bariatric procedure as demonstrated by Baltasar et al. The basic principle of LSG is to create a narrow stomach along the lesser curvature, depending on the left gastric artery, using a calibration bougie as a template to perform a vertical partial gastrectomy, resecting the greater curvature and fundus of the stomach according to the International Sleeve Gastrectomy Expert Panel Consensus Statement by Rosenthal et al. The procedure has demonstrated excellent outcomes in terms of weight loss and comorbidity resolution, making it one of the most commonly performed bariatric procedures worldwide according to the IFSO Worldwide Survey by Angrisani et al. Bougie Size Considerations and Rationale The selection of an appropriate bougie size during laparoscopic sleeve gastrectomy represents a critical technical decision that significantly influences both immediate surgical outcomes and long-term patient results. Calibration bougies serve as internal templates to standardize the gastric sleeve diameter and ensure consistent sleeve geometry across different surgeons and institutions, as described by Parikh et al. The diameter of the bougie directly determines the final gastric volume and the degree of restriction achieved, which in turn affects weight loss efficacy, food tolerance, and complication rates. Bougie sizes in current clinical practice typically range from 32-French (Fr) to 50-Fr, with most centers utilizing sizes between 34-Fr and 42-Fr according to the survey by Gagner et al. Small bougie sizes (32-36-Fr) create a more restrictive sleeve with potentially enhanced weight loss but may be associated with increased risks of stenosis, food intolerance, and gastroesophageal reflux disease as reported by Sakran et al. Medium bougie sizes (38-42-Fr) represent a compromise between restriction and safety, offering adequate weight loss while maintaining acceptable complication rates as demonstrated by Weiner et al. Large bougie sizes (44-50-Fr) provide greater sleeve capacity with improved food tolerance and potentially reduced leak rates, though concerns exist regarding long-term weight loss maintenance according to Abdallah et al. The rationale for comparing different bougie sizes stems from the ongoing debate regarding the optimal balance between surgical efficacy and safety. Recent meta-analyses have suggested that larger bougie sizes may be associated with reduced gastric leak rates without significantly compromising weight loss outcomes. However, the majority of existing evidence comes from retrospective observational studies with inherent limitations including selection bias, confounding variables, and lack of standardized outcome measures as noted by Shi et al. The current study aims to provide definitive prospective evidence comparing small (36-Fr) versus X large (larger than 40-Fr) bougie sizes in a randomized controlled trial design. Furthermore, the impact of bougie size on comorbidity resolution remains inadequately studied. Bariatric surgery has demonstrated remarkable efficacy in resolving obesity-related comorbidities, with diabetes remission rates ranging from 53% to 63% as reported by Schauer et al. and hypertension resolution rates varying from 8% to 50% depending on the specific criteria used according to Sjöström et al. The relationship between sleeve geometry, as determined by bougie size, and comorbidity resolution mechanisms requires further investigation to optimize patient outcomes and surgical technique selection.
NCT03937011
This single-arm, prospective, observational multicenter study will collect clinical data in a post-market setting across two different specialties in Robotic surgical procedures: Bariatric Sleeve gastrectomy (Staple line reinforcement) and Hysterectomy (Vaginal cuff closure). Investigators will perform the procedure using SFX Spiral PDS Plus in compliance with their standard surgical approach and the IFU.
NCT07366138
This study aims to compare the analgesic efficacy, duration of analgesia, and overall opioid consumption between the external oblique intercostal plane (EOIP) block and subcostal transversus abdominis plane (TAP) block in patients undergoing laparoscopic sleeve gastrectomy.
NCT06835166
The combined effects of obesity-related cardiac structure and function changes, comorbidities, pneumoperitoneum technique, and reverse Trendelenburg position may complicate anesthesia management by affecting intraoperative hemodynamics and cardiac function. Increased intra-abdominal pressure leads to various physiological changes through mechanical and neurohormonal responses. Furthermore, pneumoperitoneum and reverse Trendelenburg position are reported to stimulate the sympathetic nervous system and increase the risk of cardiac arrhythmia. Obesity-related changes in cardiac structure and function have been shown to predispose to cardiac conduction and repolarization disorders. It has also been stated that obesity directly affects cardiac electrophysiology. Moreover, obese patients may have hidden risks associated with the development of cardiac arrhythmias due to the adverse contributions of the cardiovascular effects of anesthesia, pneumoperitoneum, and patient positioning during laparoscopic intervention. The index of cardiac electrophysiological balance (iCEB) is a non-invasive marker calculated by the QT/QRS ratio that can predict malignant ventricular arrhythmias. The aim of this study was to investigate the effects of intraoperative patient positions on hemodynamics and the index of cardiac electrophysiological balance (iCEB) during laparoscopic sleeve gastrectomy in morbidly obese patients.
NCT06868992
The main research hypothesis is that alterations in the communication between the endoplasmic reticulum (ER) and the mitochondria at contact sites called mitochondria-associated membranes (MAMs) occurs in different hepatic cell types of patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MALSD) and is involved in the progression towards MASH and could also influence the process of improvement of MASH. This study aims to investigate the link between Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Mitochondria-Associated Membranes (MAMs) in liver cells and peripheral blood mononuclear cells (PBMCs) in patients undergoing bariatric surgery. The primary objective is to analyze MAMs alterations in hepatocytes in MASH patients compared to non-MASH patients. Secondary objectives include evaluating the correlation between MAMs in PBMCs and liver cells and assessing MAMs changes post-bariatric surgery.
NCT06474637
The objective of this prospective, single arm, single-center study is to evaluate patients who are undergoing primary sleeve gastrectomy procedures and are surgically treated with the AEON Endoscopic Powered Handle Stapler and Stapler Reload. The primary endpoint is to assess the percentage of patients who encountered post-operative staple line complications (bleeding or leak), defined as requiring blood transfusion or revision surgery due to staple line complications.
NCT07335549
Obesity is a multifactorial disease which has become a public health problem with increasing frequency, especially in recent years. Obesity causes many health problems with its negative effects on organs, systems, and psychosocial status. It is a serious risk factor for many diseases and also causes a significant increase in morbidity and mortality in these diseases. Although dietary treatments and medical treatment options are frequently used, surgical options are still the most effective treatment. Bariatric and metabolic surgical techniques are frequently applied, especially in patients with advanced obesity and obesity-related comorbidities. The most commonly applied bariatric metabolic surgical techniques, as in our clinic, are laparoscopic sleeve gastrectomy (LSG) and Roux-en-y gastric bypass procedures. The role of adipokines, secreted from adipose tissue and thought to play a role in the development of obesity, is quite important in the obesity mechanism, as they are effective not only in energy processes but also in metabolic processes. These adipokines secreted by adipose tissue play an active role in many mechanisms in the body, including vasoactivity, oxidative processes, immunity, lipid and glucose metabolism. Adipokines function actively in many target organs such as the pancreas, liver, and brain. Isthmin, a relatively new adipokine expressed from brown and white adipocytes, also affects many systems like other adipokines. Studies have shown that Isthmin plays an active role in glucose and lipid metabolism, and it has been reported to play a role in many metabolic processes, from insulin resistance to hepatic steatosis. The aim of this study is to investigate whether isthmin levels change before and after surgery in patients undergoing LSG for severe obesity, given that isthmin is thought to be associated with obesity and insulin resistance, particularly by affecting the appetite center in metabolism.
NCT06515691
Ultrasound-guided Modified Thoracoabdominal Nerve Plane Block (M-TAPA) is performed into the costochondral aspect at the 9th-10th costal level by injecting local anesthetics deep into the chondrium. It provides blockage of both the anterior and lateral cutaneous branches of the thoracoabdominal nerve. Studies show that M-TAPA block is effective for postoperative analgesia and other abdominal surgeries, but its effect on patients undergoing LSG surgery has not yet been studied. The hypothesis is that the M-TAPA block performed in patients undergoing Laparoscopic Sleeve Gastrectomy (LSG) Operation would reduce opioid consumption in the first 24 hours period after surgery.
NCT07274215
This single-center, prospective, randomized, double-blind controlled trial aims to evaluate the effects of intraoperative paragastric block (PGBLOCK) on early postoperative visceral pain, postoperative nausea and vomiting (PONV), and analgesic requirements in patients undergoing laparoscopic sleeve gastrectomy (LSG). Despite advancements in multimodal analgesia protocols, visceral pain remains a significant postoperative concern following LSG, contributing to increased opioid use and delayed recovery. Paragastric block is a novel technique targeting autonomic neural pathways-such as branches of the celiac ganglia and vagal nerves-through precise intraoperative injection of local anesthetics near the stomach. A total of 180 patients scheduled for elective LSG will be randomized in a 1:1 ratio to receive either paragastric block with 20 mL of 0.5% bupivacaine or a sham block with 20 mL of isotonic saline. Injections will be administered at six predefined anatomical sites under laparoscopic guidance after gastric resection. The surgical technique, anesthetic protocol, and postoperative care will be standardized for all participants. Both patients and clinical personnel involved in care and outcome assessment will remain blinded to group assignment. The primary outcome is the assessment of postoperative visceral pain using Visual Analog Scale (VAS) scores at 0 and 2 hours postoperatively. Secondary outcomes include PONV severity grading, mobilization status, total analgesic consumption (pethidine + tramadol), and need for rescue antiemetics within the first 24 hours post-surgery. Exclusion criteria include history of upper abdominal surgery, chronic opioid use, pregnancy, severe systemic disease, or allergy to medications used in the protocol. This study is expected to provide high-quality evidence regarding the efficacy of paragastric block in improving early postoperative recovery and reducing opioid reliance after LSG.
NCT07280845
The main questions to answer are: * Weight outcomes in weight strata over time? * What was the proportion of patients reaching sufficient weight outcome in different weight strata? * To what extent are co-morbid conditions improved or put in remission? * What is the risk of experience a complication? * What was the proportion of patients converted to another bariatric procedure? * What us the reason for conversion? Participants already undergone bariatric surgery as part of their regular medical care for severe obesity and only registry data will be analyzed.
NCT03482986
The purpose of the study is to test how dietary habit interventions affect patients weight loss outcomes after bariatric surgery.
NCT02823665
The purpose of this study is learn the effect of gastric bypass surgery and sleeve gastrectomy on glucose metabolism mediated by neural and hormonal factors initiated after eating.
NCT06835933
This study aims to investigate the patterns of reflux symptoms after laparoscopic sleeve gastrectomy based on the presence or absence of preoperative gastroesophageal reflux symptoms.
NCT07033221
Previous studies have demonstrated that obesity negatively affects the human vestibular system. However, whether improvement in vestibular function occurs following the resolution of obesity remains an area requiring further investigation. Therefore, the investigators aimed to assess and analyze vestibular system functions in patients scheduled for bariatric surgery, both before the surgery, after the surgery, and following significant weight loss. Participants aged between 18 and 60 years who meet the inclusion criteria will be enrolled in the study. Initially, participants will undergo medical history assessment and Body Mass Index (BMI) measurement. The enrolled participants will be evaluated using the following tests at three different time points-preoperatively, at the 1st month postoperatively, and at the 6th month postoperatively: Video Head Impulse Test (vHIT), static posturography test, Berg Balance Scale, SF-12 Quality of Life Scale, and the Activity-specific Balance Confidence (ABC) Scale. Although obesity has been shown to be associated with impaired postural balance, studies evaluating the direct effect of BMI on postural sway are limited. The aim of our study is to assess the vestibular system in obese patients before and after bariatric surgery. Through this, the investigators hope to contribute to the literature by providing balance assessments in individuals with obesity
NCT06970626
The goal of this clinical trial is to learn which is better, combining Dexmedetomidine infusion and paragastric neural block or combining laparoscopic TAP block and paragastric neural block to enhance recovery after laparoscopic sleeve gastrectomy. The main questions it aims to answer are: Will using paragastric neural block (PGNB) combined with dexmedetomidine infusion give better recovery or using PGNB combined with laparoscopic transversus abdominis plane (LTAP) block in patients undergoing laparoscopic sleeve gastrectomy. This will be assessed by: Recording how much opioids were consumed by the patients Hemodynamic stability of the enrolled patients Pain scores as given by the patient The quality of postoperative patient recovery How many patients encountered nausea or vomiting
NCT06970678
The goal of this clinical trial is to learn if combining Dexmedetomidine infusion and paragastric autonomic neural block will enhance the postoperative recovery of patients undergoing laparoscopic sleeve gastrectomy. The main questions it aims to answer are: Will combining the two techniques (Dexmedetomidine infusion and paragastric autonomic neural block) improve the quality of recovery? Will opioid consumption postoperatively decrease after combining those two techniques? Will the patients be able to start mobilizing sooner after surgery? Will the patient encounter less incidence of nausea and vomiting? Researchers will asses the quality of the patients' recovery by reviewing the Quality of recovery 40 (QoR 40) questionnaire filled by the patients, assessing hemodynamic parameters intra- and postoperatively, recording the opioids consumed by the patients in the postoperative period, recording the time to first mobilization of the patient, and recording the incidence of nausea and vomiting.
NCT06257771
The goal of this observational study is to learn how the body processes ingested alcohol and how alcohol affects mood and blood sugar in both men and women after undergoing sleeve gastrectomy. The main question\[s\]it aims to answer are: * Are there differences in the way that ingested alcohol is handled in men versus women after sleeve gastrectomy? * What is the consequence of drinking alcohol on an empty stomach versus after a meal on blood sugar control after undergoing sleeve gastrectomy? Participants will participate in two types of alcohol tests (alcohol given orally or administered intravenously) after not eating anything overnight or after having a meal. Researchers will compare men and women who underwent sleeve gastrectomy with men and women who had no surgery, are of similar age and body composition, and have similar alcohol intake patterns.