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Bariatric Surgery clinical trials

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NCT ID: NCT05522998 Recruiting - Bariatric Surgery Clinical Trials

Efficacy and Safety of Ciprofol in Laparoscopic Sleeve Gastrectomy

Start date: January 1, 2023
Phase: Phase 4
Study type: Interventional

To evaluate the efficacy and safety of ciprofol for the induction of general anesthesia in obese patients undergoing laparoscopic sleeve gastrectomy. A randomized, parallel, propofol injection positive control study will be conducted to select obese patients who will undergo laparoscopic sleeve gastrectomy in the author's hospital. To evaluate the efficacy and safety, the main observation index, secondary observation indexes, safety evaluation indexes, and the incidence of postoperative adverse reactions will be recorded and compared between the two groups.

NCT ID: NCT05472922 Recruiting - Weight Loss Clinical Trials

The Banded Mini Gastric Bypass Trial: A Prospective Randomized Controlled Trial

RiMini
Start date: July 1, 2022
Phase: N/A
Study type: Interventional

Rationale: Investigate if there is a significant weight reduction expressed in total body weight loss percentage (%TBWL) in patients 5 years after surgery, whom underwent a mini gastric bypass (MGB-OAGB) with addition of the implantation of a MiniMizer Ring. Study design: A prospective non blinded single centre randomized controlled trial. Sudy population: The study population will exist of patients eligible for MGB-OAGB surgery. Patients are invited to participate if Body Mass Index (BMI) ≥ 35kg/m2 with a comorbidity related to morbid obesity, or a BMI exceeding 40kg/m2. Intervention: Insertion of the MiniMizer Ring around the gastric pouch in addition to the 'standard' MGB-OAGB. Main study parameters/endpoints: Primary Objective: 1. %TBWL 5 years after surgery. Secondary Objectives: 2. Percentage Excess Weight Loss (%EWL) 5 years after surgery. 3. Decrease or reduction of comorbidities (diabetes mellitus, hypertension, hyperlipidemia, sleep apnoea, and joint complaints). 4. Improvement of quality of life: SF-36 and OBESI-Q questionnaires. 5. Incidence and severity of dumping syndrome. 6. Incidence and severity of reflux symptoms: GERD-HRQoL questionnaire. 7. Incidence and complications due to silicone band. Measurement of objectives are before surgery and six times after surgery combined with the standard postoperative care for patients who undergo bariatric surgery: Expected advantages of bOLGB versus OLGB: 1. Increase of weight reduction, and due to that decrease of comorbidities and/or mortality related to overweight. 2. Long term decrease of weight regain. 3. Decrease of incidence of dumping. Possible disadvantages of bOLGB versus OLGB: 1. Band-related complications such as erosion, infection, stenosis, or pouch dilatation. 2. Functional gastro-intestinal complains such as dysphagia and reflux.

NCT ID: NCT05428618 Recruiting - Obesity Clinical Trials

Mobile Application for Bariatric Surgery Patients

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

Introduction: One of the alternative ways, as a result of the increasing demand for health services and the inadequacy of meeting the increasing needs, is mobile health applications. According to TUIK 2019 data, the rate of having mobile phones in households is 98.7%. With the development of technology, all information can be integrated into the mobile phone, and mobile applications allow the patient to give data from the environment in which he lives and to evaluate himself. Self-assessment and monitoring of the patient enable the patient to participate in his/her self-care, supports self-management behaviors, and improves their quality of life. Objective: It was aimed to develop a mobile support application for patients undergoing bariatric surgery and to evaluate the effect of application use on patients' self-management, quality of life, and clinical outcomes. Method: In the first stage; - Preparing the information to be included in the mobile health application that is planned to be developed and evaluating the quality of the content, - Parallel to this, the adaptation of the "Bariatric Surgery Self-Management Behaviors Scale" into Turkish and the evaluation of its validity and reliability. - Design of the mobile application, transferring the educational content to the mobile application, - It is aimed to evaluate the technical suitability and usability of the mobile application. In the second stage, it was aimed to conduct a randomized controlled study to determine the effect of the developed mobile application on the self-management, quality of life and clinical outcomes of the patients. The developed mobile application will be introduced to patients at discharge after bariatric surgery. Rating scales will be administered to patients at the end of one, three, and six months after surgery. These scales are the Bariatric Surgery Self-Management Behaviors Scale and the Moorehead-Ardelt Quality of Life Scale-II. Conclusion: It is expected that the mobile application-based education to be developed for bariatric surgery will improve the patients' post-surgical self-management, increase their quality of life and decrease the early complication rates.

NCT ID: NCT05325736 Recruiting - Bariatric Surgery Clinical Trials

Improvement in Glycemic Response After Bariatric Surgery

Start date: July 1, 2021
Phase:
Study type: Observational

decipher the role of microbiota in glycemic response change after bariatric surgery

NCT ID: NCT05211375 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Comparisons of Metabolic Effect of Sleeve Gastrectomy With Duodenojejunal Bypass and Sleeve Gastrectomy (MEDUSA): A Multicenter Randomized Controlled Trial

Start date: January 3, 2022
Phase: Phase 3
Study type: Interventional

In this study, the effects of SG with DJB and SG alone for the treatment of type 2 diabetes mellitus (T2DM) will be compared in patients other than the two groups at both extremes who are expected to show excellent effects of metabolic surgery with SG alone (mild T2DM) and who need SG with DJB (severe T2DM). This study is to target patients with poor blood sugar control despite current medical treatment, although the beta-cell function of the pancreas is preserved. Therefore, this study is aimed at patients who have been using insulin for less than 10 years with T2DM, or taking diabetic medications with HbA1c ≥ 7.0% for less than 10 years with T2DM. The investigators hypothesize that the treatment effects of SG with DJB for T2DM will be superior to that of SG in this group

NCT ID: NCT05189756 Recruiting - Clinical trials for Postoperative Nausea and Vomiting

Dual-dose Aprepitant to Reduce Postoperative Nausea and Vomiting After Laparoscopic Bariatric Surgery.

DDA-PONV
Start date: March 17, 2022
Phase: Phase 4
Study type: Interventional

Postoperative nausea and vomiting (PONV) is unpleasant and increases health care costs. Despite modern techniques and prophylaxis, PONV rates remain high after laparoscopic bariatric surgery. We aim to reduce PONV after laparoscopic bariatric surgery using aprepitant with a similar scheme used for emetogenic chemotherapy.

NCT ID: NCT05092659 Recruiting - Bariatric Surgery Clinical Trials

Patient Experience in Bariatric Surgery: Definition of New Indicators

CALEX
Start date: March 28, 2023
Phase: N/A
Study type: Interventional

Given the growing importance of placing the patient at the heart of care evaluation, the use of patient questionnaires such as Patient Reported Experience Measures (PREMS) or Patient-Reported Outcome Measures (PROMS) has become widespread in recent years. PROMS assess the outcomes of care, whereas PREMS assess the patient's experience of care. However, these tools only imperfectly reflect the patient's experience and only answer specific questions: satisfaction, pain management, waiting times, etc. Patients undergoing bariatric surgery will undergo major surgery that will have an impact on their subsequent quality of life. Preparing for this surgery is a lengthy process, involving various forms of support: psychological, nutritional, physical activity, and so on. Exploring patients' experiences in depth, based on their account of their care experience, can enable carers to better understand and apprehend this type of journey from a perspective closer to that of the patient.

NCT ID: NCT04868032 Recruiting - Bariatric Surgery Clinical Trials

Gaining Optimism After Weight Loss Surgery (GOALS) II

GOALS
Start date: July 1, 2022
Phase: N/A
Study type: Interventional

This randomized controlled trial examines the feasibility, acceptability, and preliminary impact of an adapted positive psychology-motivational interviewing (PP-MI) intervention for physical activity among patients who have recently undergone bariatric surgery compared to an enhanced usual care control.

NCT ID: NCT04800640 Recruiting - Obesity, Morbid Clinical Trials

Use of Electroanalgesia in Pain and Pulmonary Function.

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

It is a consensus in the literature that changes in lifestyle and carbohydrate-rich diet are part of a context that has led to an obesity pandemic. Its treatment is multidisciplinary, however, in many cases, conventional therapy has no effect, requiring surgical intervention. The latter, in turn, is not free of risks and causes important changes in lung function. Therefore, this study aims to evaluate the effect of electroanalgesia through conventional transcutaneous nerve stimulation (TENS) on pulmonary function in the postoperative period of bariatric surgery.

NCT ID: NCT04746703 Recruiting - Bariatric Surgery Clinical Trials

New Imaging Tools to Explore Impact of Bariatric Surgery on Pancreatic Lesions: PACHIBA- Bariatric Surg

PACHIBA
Start date: February 10, 2021
Phase: N/A
Study type: Interventional

The investigators propose an exploratory study aiming at assessing the impact of surgical bariatric treatment on the improvement of pancreatic lesions detected by MRI. Pancreatic MRI will be performed in severe-obese patients with a planned bariatric surgery, before and 6 months after bariatric surgery. To assess the impact of bariatric surgery on pancreatic Magnetic Resonance Imaging (MRI) parameters in severe-obese patients