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Bariatric Surgery Candidate clinical trials

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NCT ID: NCT05930639 Recruiting - Clinical trials for Bariatric Surgery Candidate

The Effect of the Care Bundle to be Applied to Obesity Surgery Patients on Surgical Site Infection and Patient Comfort

Start date: June 12, 2023
Phase: N/A
Study type: Interventional

One of the most effective treatment methods of obesity is surgery. Bariatric surgery is classified as a clean-contaminated wound. The expected benefit from surgery is weight loss. However, surgical site infection is among the complications. Although many methods are applied to reduce these rates, it is not very possible to reduce them to zero. It is predicted that the incidence of infection will decrease with surgical care packages created from the combination of evidence-based interventions applied. This study was a randomized controlled trial designed to determine the effect of the Surgical Site Infection (SSI) prevention package on SSI and patient comfort in patients undergoing bariatric surgery. The questions to be answered by the research are; - What is the effect of the care package applied to patients undergoing bariatric surgery on surgical site infection? - What is the effect of the care package applied to patients undergoing bariatric surgery on comfort? .Patients aged 18 and over who have had bariatric surgery (sleeve gastrectomy) will be taken from a private hospital in Kayseri. All surgeries will be performed by the same surgeon. The care package (identification of risk factors, antibiotic prophylaxis, normothermia, normoglycemia and patient education) prepared for the experimental group will be applied. On the 30th day, the patient is called by phone and the surgical site infection findings are questioned.

NCT ID: NCT05863221 Recruiting - Postoperative Pain Clinical Trials

ZYNRELEF® for Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy

HeronBariatric
Start date: May 9, 2023
Phase: Phase 4
Study type: Interventional

Approximately 120 subjects will be randomized into 1 of the following 2 treatment groups in a 1:1 ratio: Group 1: ZYNRELEF® up to 200 mg/ 6mg ( 7ml vial) via instillation at all incision sites in addition to 30 ml of 0.5% Ropivacaine + 10mg dexamethasone. Postoperatively, intermittent IV acetaminophen will be administered as per need till discharge. Group 2: 30 ml of 0.5% Ropivacaine and 10mg dexamethasone into all surgical sites and intermittent IV acetaminophen as per need till discharge. Primary Objective: To compare the efficacy and duration of analgesia achieved following the instillation of ZYNRELEF® all incision sites in addition to Ropivacaine with dexamethasone + postoperative IV acetaminophen, to the standard treatment of Ropivacaine with dexamethasone + postoperative IV acetaminophen in subjects undergoing laparoscopic sleeve gastrectomy. Secondary Objectives: 1. To evaluate additional efficacy parameters, including opioid load, in this study population. 2. To determine the impact of ZYNRELEF® on the cost of pain management. 3. To assess the time taken to resume exercise after discharge. 4. To assess the adverse events reported following the use of ZYNRELEF®.

NCT ID: NCT05859022 Recruiting - Obesity Clinical Trials

Metabolic Effects of Bariatric Arterial Embolization vs Bariatric Surgery

BEOD
Start date: June 16, 2021
Phase: N/A
Study type: Interventional

Obesity and Type 2 diabetes mellitus (DMT2) are two of the most common chronic diseases of the Western society. Obesity is one critical factor in DMT2 development, with weight loss having profound beneficial effects on DMT2 and improving the metabolic pathophysiology leading to hyperglycemia. Observational studies reported that surgical intervention of morbid obesity achieved significant improvement of resolution of DMT2, both in short and long-term. Bariatric surgery has been considered the best option for treatment of diabetic obese patients, with the laparoscopic Roux-en-Y Gastric Bypass being the gold standard of the surgical treatment. Bariatric arterial embolization (BAE) technique has proved to be safe effective for weight loss in obese patients, but its metabolic effects have not been studied yet. The hypothesis of the study is that BAE is effective for the resolution of DMT2 inpatients with BMI between 30-43 Kg/m2. The aim is to assess DMT2 remission after BAE and bariatric surgery, to analyze potential conditioning factors, and to compare remission criteria between bariatric surgery and BAE.

NCT ID: NCT05845359 Withdrawn - Clinical trials for Bariatric Surgery Candidate

Intraoperative Methadone for Postoperative Pain Control

Start date: September 2023
Phase: Phase 4
Study type: Interventional

To compare patient pain perception and satisfaction as well as opioid-related side effects during inpatient and outpatient care when undergoing bariatric enhanced recovery after surgery protocols with and without methadone.

NCT ID: NCT05843812 Active, not recruiting - Clinical trials for Bariatric Surgery Candidate

Magnesium Sulfate in Bariatric Surgery

MgSObs
Start date: April 21, 2023
Phase:
Study type: Observational

Weight loss surgery, also known as bariatric surgery, has been around since the 1950s and since its inception has been shown to successfully achieve significant and sustainable weight loss in a large number of patients who undergo this intervention, as well , if a beneficial impact is observed in the management of metabolic disorders, such as type 2 diabetes mellitus and hyperlipidemia. After bariatric surgery, patients are at risk of narcotic-related side effects.(2) Because of this, pain management strategies must be implemented to reduce the consumption of narcotic medications. Some studies have reported that a multimodal analgesic regimen can reduce the consumption of postoperative narcotics, as well as the therapy requirements to control postoperative nausea and vomiting. It has also been reported that excess body mass is associated with changes in mineral levels in the body, particularly hypomagnesemia , a condition that is also common in hospitalized patients (Hansen & Bruserud 2018), and has a high incidence in the perioperative environment. Magnesium sulfate (MgSO4) has multiple desirable effects in an anesthetic procedure. It is an antagonist of the N-methyl-d-aspartic acid (NMDA) receptor, which is why it produces an analgesic effect related to the prevention of central sensitization caused by peripheral tissue injury. In addition, other relevant clinical effects of MgSO4 have been reported in anesthesiology, such as its effect as a CNS depressant, modulation of the hemodynamic response, reduction of the intraoperative requirements of anesthetics, analgesics, and muscle relaxants. As well as the potentiation of the effect of non-depolarizing muscle relaxants. The role of magnesium in the body and its pharmacological properties continue to be studied and knowledge of its pharmacological, clinical and physiological characteristics has become essential for the anesthesiologist. There are no previous studies that allow establishing an optimal therapeutic scheme considering all the perioperative clinical effects of MgSO4 and that evaluate the role of genetic variability in pain perception and response to treatment in bariatric surgery.

NCT ID: NCT05839704 Recruiting - Surgery Clinical Trials

A Comparison of Two Regional Techniques for Bariatric Sleeve Gastrectomy

Start date: March 2, 2023
Phase: N/A
Study type: Interventional

Regional anaesthetic techniques, or nerve blocks, are commonly used to provide postoperative pain relief for patients undergoing surgery. At present in University Hospital Galway, it is standard practice for patients undergoing bariatric sleeve gastrectomy surgery to receive a regional anaesthetic technique to improve their postoperative pain. There are a number of different regional anaesthetic options available for this surgery, but as yet, published evidence regarding which specific approach confers most benefit for patients is lacking. This study aims to compare two regional anaesthetic techniques - erector spinae plane blockade versus serratus anterior plane blockade plus subcostal transversus abdominus plane blockade - and assess if one approach provides a superior quality of recovery postoperatively for sleeve gastrectomy patients over the other.

NCT ID: NCT05801900 Not yet recruiting - Postoperative Pain Clinical Trials

Intravenous Ibuprofen Versus Ketorolac in Bariatric Surgery

Start date: April 2023
Phase: N/A
Study type: Interventional

The aim of the current study is to compare the analgesic effects of both drugs in patients with obesity undergoing bariatric surgery.

NCT ID: NCT05798702 Active, not recruiting - Weight Loss Clinical Trials

Fibrosis Reduction in Non Alcoholic Steatohepatitis

FRIN
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Background: Non-Alcoholic Steatohepatitis (NASH) represents one of the stages of Non-Alcoholic Fatty Liver Disease (NAFLD) with a very high risk to evolve in cirrhosis and hepato-carcinoma. Currently, the only diagnostic method is a liver biopsy that remains the gold standard for characterizing liver histologic alterations and fibrosis stages. There is no specific treatment for NASH, in fact no drugs are currently licensed specifically for treating this disease. Aim: Our aim is to conduct a non-inferiority, randomized-controlled trial (RCT) comparing Roux-en-Y Gastric bypass (RYGB) with an intensive lifestyle modification plan (Very low-calorie diet, VLCD) for the reduction of advanced stages of fibrosis in subjects with obesity and NASH after 25% weight loss.

NCT ID: NCT05790317 Completed - Diabetes Clinical Trials

Comparison of the Effect of Traditional Method and Eras Protocol in Obesity Surgery

Start date: February 14, 2022
Phase: N/A
Study type: Interventional

This study was conducted to compare the effectiveness of care based on the "Accelerated Recovery After Surgery (ERAS) Protocol" and the traditional method in bariatric surgery and demonstrate the difference the two methods based on evidence.

NCT ID: NCT05752799 Recruiting - Clinical trials for Bariatric Surgery Candidate

Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare Opioid Free and Opioid Based Anaesthesia in patients undergoing sleeve gastrectomy. The main questions it aims to answer are: - Will the total dose of intraoperative opioid be reduced? - Will there be difference in pain scores between groups? Participants will be managed with the Nociceptive Level Index algorithm to guide intraoperative analgesia. The Opioid Free Anaesthesia Group will be administered the Multimix infusion (Magnesium sulfate, dexmedetomidine, ketamine). The Opioid Based Anaesthesia Group will receive fentanyl as a bolus dose and remifentanil infusion. Rescue fentanyl bolused will be injected as appropriate according to nociceptive level (NOL) values.