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Obesity, Morbid clinical trials

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NCT ID: NCT04902729 Completed - Clinical trials for Post Partum Hemorrhage

Oxytocin vs Carbetocin at Cesarean Delivery in Women With Morbid Obesity

Start date: July 20, 2021
Phase: N/A
Study type: Interventional

Postpartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly used uterotonic drug for the active management of third stage labor, to reduce the risk of PPH and help deliver the placenta. Carbetocin is currently recommended by the SOGC (Society of Obstetricans & Gynecologists of Canada), and is a relatively newer drug with a longer duration of action. It has been previously demonstrated that women with elevated BMI require higher doses of these drugs to induce adequate uterine contraction and dose finding studies undertaken at Mount Sinai Hospital have shown that the ED 90 in obese patients to be carbetocin 80 mcg and oxytocin 1IU. Furthermore, previous studies have indicated that the use of carbetocin over oxytocin in non-obese popultion is associated with reduced bleeding and requirement of additional uterotonic medications. No study has directly compared the two drugs in obese parturients in a head to head clinical trial; therefore a double-blind randomized controlled trial is necessary to show the non-inferiority of carbetocin against the current standard of care at Mount Sinai hospital, which is oxytocin.

NCT ID: NCT04902625 Recruiting - Clinical trials for Bariatric Surgery Candidate

Use of Mysimba in Patients With Weight Regain After Bariatric Surgery

Start date: March 21, 2023
Phase: Phase 4
Study type: Interventional

Although bariatric surgery is currently the most effective treatment for morbid obesity, weight regain occurs in 16-37% of the patients (1). Weight regain is not regularly treated with antiobesity medications (AOMs). Mysimba (Contrave in US) is a AOM, it is a combination of naltrexone hydrochloride extended release and bupropion hydrochloride extended release for the treatment of obesity, and is used with lifestyle modification. Bupropion is a mild reuptake inhibitor of dopamine and norepinephrine. Naltrexone, an opioid antagonist has minimum effect on weight loss on its own. Naltrexone is thought to block the inhibitory effects of opioid receptors activated by the β-endorphin released in the hypothalamus that stimulates feeding, thus allowing the inhibitory effects of α-melanocyte stimulating hormone to reduce food intake. In patients with obesity usage of Naltrexone/Bupropion (NB) results in up to 8.2% weight loss (2). There is some evidence that also in bariatric patients with weight regain NB leads to additional weight loss (3, 4). At the Nederlandse Obesitas Kliniek (NOK) weight regain at follow-up is currently treated with the Back on Track (BOT) program. The BOT program is an extra intervention our clinic provides for the patients who have weight regain after surgery, this is part of our standard care program. The primary objective is to study the effect of naltrexone/bupropion in combination with the BOT module on successful weight loss(>5% weight loss) after 22 weeks in patients with weight regain after bariatric surgery, compared to the regular BOT module.

NCT ID: NCT04894838 Recruiting - Obesity, Morbid Clinical Trials

DIStal gastriC Bypass OUtcome in Revision SurgEry After Roux-en-y Gastric Bypass

DISCOURSE
Start date: May 1, 2021
Phase: N/A
Study type: Interventional

This study is designed as a prospective multicenter randomized controlled clinical trial comparing two surgical techniques of distal gastric bypass (DGB) in revisional surgery following failed Roux-en-Y gastric bypass. Patients will be randomly allocated 1:1 to A) DGB with lengthening of the BPL (DGB type I) or B) DGB with extended AL (DGB type II). Randomisation is stratified for participating center. The study will be performed in a clinical and out-patient setting with regular visits at 1.5, 3, 6, 12, 18, 24 and 36 months post intervention. The study will be set up as a multicenter study with bariatric centers: St. Antonius hospital, Groene Hart hospital, OLVG, Rijnstate hospital, Elisabeth Twee-steden Hospital, Bravis hospital, Medisch Centrum Leeuwarden, Catharina Hospital.

NCT ID: NCT04880902 Completed - Clinical trials for Bariatric Surgery Candidate

Volumetric Pouch Study After Laparoscopic Sleeve Gastrectomy

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

This study aimed to evaluate Laparoscopic Sleeve Gastrectomy in the treatment of morbidly obese patients pre and post-operatively after 3 months, 6 months, and 1-year follow-up and assess the volumetric changes of the gastric reservoir 1 year after LSG using multi-slice computer tomography.

NCT ID: NCT04861961 Completed - Morbid Obesity Clinical Trials

Comparison of Three Hypoabsortive Surgical Techniques for Treatment of Type IV Morbid Obesity

BAR-3
Start date: April 6, 2021
Phase: N/A
Study type: Interventional

Morbid obesity is the first non-traumatic cause of death in the western population and it is also progressively beginning to affect the developing countries. Bariatric surgery provides better results than pharmacological treatments and lifestyle changes, granting a better control of comorbidities. Duodenal switch (DS) has proben to be the most effective surgical treatment for grade IV morbid obesity and its comorbidities. However, it is not widely used due to its technical complexity and the risk of long-term complications. Single Anastomosis Duodenum-Ileal bypass with Sleeve gastrectomy (SADI-S) was concieved in 2007 as a one-anastomosis simplification of DS, intended to diminish the surgical time and postoperative risks. Recently, another simplified hypo-absorptive technique has started to be widely used: the one anastomosis gastric bypass (OAGBP), also called mini-gastric gypass. It consists of a gastric pouch associated with a gastro-jejunal anastomosis in omega (Billroth II). Despite the potential advantages of these emerging surgical techniques (SADI-S and OAGBP), there is no solid evidence on its efficacy for the treatment of grade IV obesity in comparison with DS. Besides, there is also there is a lack of studies reporting on prospective acid and bile reflux after omega digestive reconstructions, suche as "Billroth II-like" (SADI-S) and "Billroth II" (OAGBP). Bile reflux is potentially premalignant condition. This prospective randomized study aims to compare conventional DS with SADI-S and OAGBP. We include all morbidly obese patients with BMI ≥ 50 kg/m2 aged 18 years or more. Exclusion criteria are patients who do not fulfill our preoperative bariatric assessment for surgery and those with contraindications for hypo absorptive or mixed surgery. The main objective of the study is to compare the percentage of excess weight lost at 2 and 5 years after the three different surgical procedures. As a secondary objective, gastroesophageal reflux (GERD) will be compared before and 2 years after surgery, based on GERD symptoms test, gastroscopy and a esophageal pH-impedanciometry in selected patients. Other secondary objectives are comparison of short-term complications, metabolic comorbidities, depositional habit, quality of life and metabolic and nutritional deficiencies at two years of surgery.

NCT ID: NCT04854252 Completed - Opioid Use Clinical Trials

Inflammatory Response to Opioid Versus Opioid Free Anesthesia

Start date: November 12, 2020
Phase: N/A
Study type: Interventional

Anesthetic agents, including opioids can modulate the altered immune function in patients with obesity through mechanisms that involve the expression and release of cytokines. For this reason, anesthetic care in patients with obesity remains controversial. Therefore, the aim of the study was to compare the effect of opioid-containing anesthesia vs opioid-free anesthesia using the Cortínez-Sepúlveda model on serum levels of IL-6, IL-1β and TNF-α before and after surgery in obese patients undergoing bypass surgery. Methods: A randomized cross-sectional study of 40 unrelated obese adults was performed in the Anesthesiology and Bariatric Surgery Service at the Civil Hospital of Guadalajara "Dr. Juan I. Menchaca". Before undergoing laparoscopic Roux-en-Y gastric bypass, patients were randomly assigned to two anesthesia groups: opiod-containing (n=20) or opioid-free (n=20). The opioid used in the opioid-containing anesthesia group was fentanyl. To characterize the disposition of intravenous propofol for the target-controlled infusion technique in obese patients, the Cortínez-Sepúlveda pharmacokinetic model was used. Body mass was determined to the nearest 0.05kg using a balance scale (Seca 703; Seca, Hamburg, Germany). Blood samples were taken before and immediately after surgery and cytokine serum levels were determined with ELISA kits. Statistical analyses were performed using the IBM Statistical Package for the Social Sciences software package version 20.0 (IBM Corp., Armonk, NY, USA).

NCT ID: NCT04852198 Recruiting - Obesity Clinical Trials

Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial

Roux-en-WHY?
Start date: December 13, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the safety and efficiency of OAGB compared to RYGB

NCT ID: NCT04849403 Completed - Obesity, Morbid Clinical Trials

TROCAR SITE HERNIA AFTER LSG

Start date: January 1, 2015
Phase: N/A
Study type: Interventional

Today, laparoscopic sleeve gastrectomy (LSG) has become the most frequently performed bariatric surgical method. One of the complications seen after LSG is trocar site hernia (TSH). There is no clear information about the rate of TSH detected radiologically after LSG. Thick abdominal wall and failure to adequately expose the facial defect related to this, mobility limitations due to excessive subcutaneous fatty tissue are the reasons accused for increased incidence of TSH. Demographic characteristics and postoperative weight loss of patients who underwent LSG procedure in our clinic between January 2015 and June 2017 and whose facial defects in the trocar region were repaired with the Carter-Thomason Suture Passer (CTSP) were evaluated. TSH evaluation was made both by physical examination and superficial USG by a general surgeon who had radiological training on concurrent superficial abdominal ultrasonography (USG). Detected TSHs were divided into two groups as symptomatic and asymptomatic.

NCT ID: NCT04844320 Active, not recruiting - Back Pain Clinical Trials

THE EFFECT OF FAST WEIGHT EFFICIENCY AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY ON THE COBB ANGLE IN MORBID OBESE PATIENTS

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

Obesity has become an increasingly common health problem today. In this context, although many anatomical, physiological and metabolic problems arising from obesity in morbid obese patients are tried to be solved in daily practice, it has been proven that eliminating obesity is sufficient in the treatment of many diseases. When we look at the literature, it is known that morbid obesity causes deformation and excessive wear in most body joints. When morbid obesity disappears, it has been shown that the previously existing neck, waist, back and knee pains regress. The aim of this study is to reveal the Cobb angle change in morbidly obese patients who achieved rapid weight loss after obesity surgery; To investigate the effect of weight loss on vertebral anatomy.

NCT ID: NCT04841057 Enrolling by invitation - Metabolic Syndrome Clinical Trials

Biometabolic Outcomes After Weight Loss Surgery: An Individualized Approach

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

Variable outcomes after weight loss surgery are likely attributable to complex, poorly understood mechanisms. Due to the significant impact that morbid obesity has on a patient's health, successful management of obesity and its related comorbid medical conditions is important and thus necessitates continued improved therapies for treating obesity. Although the mechanisms of weight loss after surgical intervention are poorly understood, improved understanding of molecular and metabolic changes that occur after weight loss surgery may offer the ability to provide targeted precision therapy for patients with morbid obesity undergoing surgical therapy. In this proposal, the investigators will combine a clinical trial whereby modifications to the gold-standard for weight loss surgery, the gastric bypass, are evaluated while simultaneously measuring molecular and metabolic changes that occur in response to these weight loss procedures. Through creating variable lengths of bypass intestine after gastric bypass, the investigators will be able to determine the effect of malabsorption on clinical outcomes and mechanisms involved in weight loss after gastric bypass. The investigators will also use two control groups. One will be a surgical weight loss control group and consist of patients undergoing a laparoscopic sleeve gastrectomy, a non-intestinal bypass procedure. The other group will consist of patients having non-surgical weight loss therapy. To asses metabolic changes that occur in response to surgical weight therapy and specifically intestinal bypass and malabsorption, the investigators will examine changes in the gut microbiome and plasma gut enteroendocrine hormones. To evaluate molecular pathways that are impacted as a result of gastric bypass and malabsorption, the investigators will measure circulating microRNAs (miRNAs) in the blood. Measurement of miRNAs will provide data on an easily measurable molecular marker for each treatment group. This is a first step in translational exploration of mechanisms of weight loss after surgery by evaluating both clinical and molecular/metabolic outcomes and begin an explorative process towards creating an individualized approach to improving outcomes after weight loss surgery.