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Bariatric Surgery Candidate clinical trials

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NCT ID: NCT04524429 Recruiting - Obesity Clinical Trials

Quality of Life After Bariatric Surgery

Start date: June 23, 2020
Phase:
Study type: Observational

This study aims to assess long term outcomes for patients who have underwent bariatric surgery. In particular, it aims to assess the quality of life of these participants.

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: 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: 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: NCT04366999 Recruiting - Clinical trials for Bariatric Surgery Candidate

Effectiveness of Bariatric Surgery for NAFLD/NASH

Start date: April 21, 2020
Phase:
Study type: Observational

This is a prospective, multicenter cohort study, which subjects were obese patients requiring bariatric surgery. This study aims to explore the the effectiveness of bariatric surgery for NAFLD/NASH with fribrosis, to explore the differences in the effectiveness among sleeve gastrostomy [SG], Roux-en-Y gastric bypass [RYGB], or one anastomosis gastric bypass [OAGB], and to explore the independent effectiveness of bariatric surgery in histological remission of NAFLD/NASH. The first stage of the cohort was started in 2020, named Base-NAFLD; In May 2024, based on Base-NAFLD, we plan to continue established a secondary cohort, named Base-NASH.

NCT ID: NCT04240626 Recruiting - Surgery Clinical Trials

Multimodal Analgesia Effect on Post Surgical Patient

Start date: January 20, 2021
Phase: Phase 4
Study type: Interventional

Patients undergoing Bariatric Surgery at the University of California Davis Medical Center will be divided into two groups, one receiving Standard of Care pain control medications vs the second group which will receive non-narcotic pain medications with rescue pain medications available if needed

NCT ID: NCT04237311 Recruiting - Obesity Clinical Trials

Bariatric Surgery and Male Reproductive Function

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

Obesity is a global public health problem. According to literature reports, as of 2016, China's obese population has reached more than 90 million and type 2 diabetes mellitus has reached more than 100 million, which has brought a serious health and economic burden to China. In addition to various health problems such as cardiovascular, osteoarthritis, and tumors, obesity can also cause abnormalities in reproductive endocrine. In women, it can cause abnormal menstruation, polycystic ovary syndrome, and male obesity can cause secondary gonadal. Hypofunction (MOSH). MOSH is an endocrine dysfunction. It is reported to have a prevalence of approximately 45% in moderate to severe obesity. In addition, studies have pointed out that the prevalence of hypogonadism in men with type 2 diabetes and obesity higher. However, there are no studies on the reproductive function of Chinese male patients after bariatric surgery. Pre- and post-operative semen will be collected for analysis to observe the effect of bariatric surgery on male reproductive function.

NCT ID: NCT04179188 Recruiting - Obesity Clinical Trials

Impact of Bariatric Surgery in Obese Patients With and Without Obstructive Sleep Apnea Syndrome

COLOSS
Start date: October 9, 2019
Phase:
Study type: Observational

It has been shown to date that obesity is associated with increased mortality and that weight loss significantly improves cardiovascular risk factors. Among patients receiving bariatric surgery, 30-90% have moderate to severe obstructive sleep apnea (OSA) syndrome. Given the strong associations between OSA and cardiometabolic comorbidities, this project is based on the hypothesis of a lower improvement of cardiovascular risk factors and a higher number of post-surgical complications in OSAS patients.

NCT ID: NCT04174768 Recruiting - Clinical trials for Bariatric Surgery Candidate

The Effect of Bariatric Surgery on Glucose Metabolism

Start date: November 19, 2018
Phase: N/A
Study type: Interventional

This prospective, single arm, longitudinal study aims to assess the effect of bariatric surgery on glucose metabolism and kidney function.