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Bariatric Surgery Candidate clinical trials

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NCT ID: NCT04494048 Recruiting - Obesity Clinical Trials

Endoscopic Bariatric Therapies (EBTs): A Retrospective and Prospective Multicenter Registry

EBT
Start date: April 5, 2016
Phase:
Study type: Observational

The purpose of this registry study is to collect data through medical chart review and in patient visits on the efficacy and safety of various Endoscopic Bariatric therapies (EBTs). This is a retrospective and prospective, observational, medical chart review study for at least 6 standard of care visits up to 5 years after a subject consents for study participation.

NCT ID: NCT04481880 Completed - Morbid Obesity Clinical Trials

Correlation of Intra-abdominal Pressure With Gastric and Urinary Bladder Pressures in Patients With Morbid Obesity

Start date: January 1, 2012
Phase:
Study type: Observational

The correlations between gastric and urinary bladder pressures with Intra-abdominal pewssure have not been addressed

NCT ID: NCT04480034 Recruiting - Covid19 Clinical Trials

Obesity Surgery During 2020 Italian Pandemic

Start date: July 15, 2020
Phase:
Study type: Observational

The first person-to-person Coronavirus disease (COVID-19) transmission in Italy was reported on Feb 21st, 2020, causing one of the most massive outbreak in Europe so far that stopped immediately all elective surgical procedures. Bariatric surgery represents the most effective treatment to obtain an important, long-term weight loss and comorbidities' resolution, including respiratory disorders. A sensitive decrease of epidemic has been observed lately and a gradual and progressive stop of the lockdown (phase 2-3) was planned, when the virus is supposed to be under control and protocols are guiding the restart of the elective bariatric surgery. Several questions are currently open: Laparoscopic bariatric surgery is safe in the phase 2-3? What's the expected complications rate? The actual hospital protocols are effective to minimize the risk of postoperative COVID-19 infection? Aim: to analyse results of bariatric surgery during phase 2-3 COVID-19 pandemic in Italy. Primary end point: 30 days COVID-19 infection, mortality and complications. Secondary end points: readmission rate 30 days, reoperations for any reason related to surgery. Study design: prospective multicenter observational. Setting: Italian National Health Service 8 high-volume bariatric centres. Enrollment criteria: No previous Covid-19 infection; Primary, standard IFSO approved bariatric procedures; No concomitant procedure; No previous major abdominal surgery; >18<60 years old; Compensated comorbidities; Official SICOB's surgical informed consent given, including COVID-19 addendum; Adherence to very restrictive protocols regarding: hospital admission, management of in-hospital patients and after discharge. Follow-up: scheduled outpatient visit 30th postoperative day. Data evaluation: all the cases performed during July/December 2020 will be collected in a prospective database. Patients operated during the period July/December 2019 in the same centers will be considered comparative group (control). Expected results: Transparent information to the patients, and the introduction of the COVID-19 protocol concerning patients and health-professionals protection, should guarantee a safe restart of bariatric surgery in Italy. The network of 8 high-volume centers sharing information and protocols in this "unexplored" period will be a guarantee for patients' safety. Bariatric surgery should induce a postoperative amelioration of the comorbidities reducing the risks in case of a second outbreak.

NCT ID: NCT04478331 Recruiting - Clinical trials for Bariatric Surgery Candidate

Effects of Technology-based Physical Activity Interventions for Women After Bariatric Surgery

OCAPAS
Start date: October 26, 2020
Phase: N/A
Study type: Interventional

Regular physical activity (PA) is essential throughout bariatric surgery (BS) management, especially for the long-term maintenance of weight loss. To optimize physical activity counseling and monitoring, the use of technology seems appropriate and effective. A recent meta-analysis provided proof of efficacy for mobile technology to increase physical activity or weight loss in the short term. Videoconferencing may also be effective, especially as it reduces the barriers related to face-to-face physical activity interventions. Both technologies (mobile and videoconferencing) seem particularly interesting for bariatric surgery management, but their long-term effects on physical activity maintenance are unknown. Moreover, the mechanisms underlying their effectiveness, such as technology acceptability and motivational processes, have not been examined. The purpose of this study is to determine the effects of two technology-based (mobile technology and videoconferencing) PA programs after BS compared to standard care and to assess the contribution of acceptability and motivational mechanisms in explaining these effects on behavioral measure of PA, physical measures, and health indicators. One hundred and twenty young women who have undergone BS in the last 3 to 6 months will be included. The volunteers will be randomly assigned to one of three arms: standard care (CONTROL), access to an internet-based physical activity program delivered by an eHealth platform associated with an activity bracelet (ACTI-MOBIL), or access to a physical activity program delivered via videoconferencing (ACTI-VISIO). The primary outcome is the distance traveled during a 6-minute walk test relativized according to Capadaglio's theoretical distance. Secondary outcomes are behavioral measures of physical activity, physical measures, health indicators, technology acceptability, and motivational concepts. Data will be collected baseline (T0), 3 months (T3) and 6 months later (T6). The technology groups will receive a PA program for 12 weeks (between T0 and T3). A mixed model approach will be used to analyze the change in outcomes over time for each group. This study will provide information on the effects of two technology-based physical activity programs (mobile technology and videoconferencing) after bariatric surgery. Based on the results, recommendations for implementing these programs will be made.

NCT ID: NCT04469712 Active, not recruiting - Metabolic Syndrome Clinical Trials

Non-randomized Prospective Comparison Between SASI Bipartition and RYGB

Start date: August 1, 2020
Phase:
Study type: Observational [Patient Registry]

The main aim of this project is to assess the safety and efficiency of the SASI Bipartition.

NCT ID: NCT04466943 Active, not recruiting - Clinical trials for Bariatric Surgery Candidate

The Impact of Moderate Versus Deep Neuromuscular Blockade on Enhanced Recovery After Bariatric Anesthesia

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Most published articles suggest that deep neuromuscular blockade is required for bariatric surgery. However, the evidence for such practice is still inconclusive. From the clinical experience at a major bariatric center of volume exceeding six hundred procedures annually, the investigators believe that moderate neuromuscular blockade will provide an adequate surgical condition and significantly facilitate enhanced recovery after bariatric procedures.

NCT ID: NCT04451499 Recruiting - Clinical trials for Bariatric Surgery Candidate

The Effect of Adding Smartphone-based Platform to the Bariatric Surgery Preparation Process

Start date: January 2021
Phase: N/A
Study type: Interventional

A randomized controlled trial on 40 bariatric surgery candidates who will be randomized into two arms (app vs. control). All the participants will receive the standard care of 3-6 preparation to bariatric surgery meetings with a dietitian, and only those participants who will assigned to the experimental group will get access to our study's smartphone app site during this period. Evaluations will be performed at baseline, at the end of the intervention phase (after 3-6 meetings as needed) and at 1 and 2 years post-surgery (data will be collected at 1 and 2 years post-surgery by phone calls). Data which will be collected for this study include:demographics and medical data, anthropometrics including body composition analysis, handgrip Strength, physical activity, hydration state, bariatric surgery knowledge questionnaire, quality of life by visual analogue scale, compliance to dietary and lifestyle BS recommendations, readiness for surgery, the subject's experience regarding the smartphone app, surgical data and adherence to post-surgical follow-up by the bariatric team.

NCT ID: NCT04450082 Completed - Clinical trials for Bariatric Surgery Candidate

One Anastomosis Gastric Bypass After Sleeve Gastrectomy Failure

Start date: January 1, 2014
Phase:
Study type: Observational

This study is a retrospective analysis of prospectively collected data on 582 obese patients. The primary aim of the study was to evaluate %Excess Weight Loss, Body Mass Index (BMI) and remission of comorbidity at mid- and long-term follow-up after One Anastomosis Gastric Bypass in subjects previously underwent Sleeve Gastrectomy. The secondary aim was to investigate the onset of esophagitis and gastritis at Upper Endoscopy (UE) and the presence of nutritional deficiencies in patients undergoing One Anastomosis Gastric Bypass as a redo surgery

NCT ID: NCT04442139 Completed - Obesity Clinical Trials

Patient Reported Outcomes of a "Tailored" Bilio-Pancreatic Limb Length on Daily Food Choices in Mini-Gastric Bypass

TaBLFood-MGB
Start date: January 1, 2008
Phase:
Study type: Observational

Bariatric surgery (BS) has a history of new procedures and techniques arising and then disappearing due to problems and complications. The present is no different with new and old procedures changing with the regularity of night following day. One of the important questions today in BS is the length and or need/value of the Biliopancreatic limb bypass (BPLL.) The Sleeve and the Band have "0" bypass, the RNY has a "short" bypass and the Biliopancreatic Diversion type procedures have a "long" (distal) bypass. The Mini-Gastric Bypass Original Technique (MGB-OT) version of the One Anastomosis Bypass (OAGB) includes a "medium" length of bypass, longer than the BPLL of the RNY and shorter than the the "Long" BPL of the BPD procedures. In addition, uniquely, the MGB-OT includes a "Tailored" BPLL. Not all OAGB surgeons use this approach and several have argued in favor of a "Fixed" BPLL of 150 cm. This paper is part of a series of studies of the "Tailored" BPLL specifically in MGB-OT patients. Notably it demonstrates in an online survey that patient reported weight loss and food choices change after MGB-OT and in addition the changes are related to the "Tailored" BPLL

NCT ID: NCT04440306 Completed - Weight Loss Clinical Trials

"Tailored" Bilio-Pancreatic Limb Length and Weight Loss After Mini-Gastric Bypass

BplVsWtLoss
Start date: January 1, 2018
Phase:
Study type: Observational

Retrospective review of prospectively collected blinded patient data. To Address simple question: In cases of Mini-Gastric Bypass performed using the Original Technique what (if any) is the relation between the Bilio-pancreatic limb length (BPLL) and the patient weight loss at 10 years following operation.