Napoleon Measurement for Gastric Bypass Evaluation
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: NYU Langone Health
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This is a clinical trial assessing the feasibility of the Napoleon device for measuring the gastrojejunal anastomosis (GJA). The study population is Roux-en-Y gastric bypass (RYGB) patients with weight regain undergoing an endoscopy at Bellevue Hospital Center or Brigham and Women's Hospital. investigators aim for a sample size of up to 100 cases. For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope. Then, they will measure the GJA with Napoleon. Investigators will compare the GJA measurements performed using visual estimation and Napoleon. A survey will be given to all endoscopists to assess the level of ease using Napoleon.
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
Is the treatment in the trial 'Napoleon Measurement for Gastric Bypass Evaluation' a promising treatment?Yes, the treatment is promising because it offers a reliable way to measure the size of the gastric outlet after surgery, which is important for successful weight loss. This method is accurate and consistent, helping doctors ensure the surgery is effective and reducing the chance of complications.125610
What data supports the idea that Napoleon Measurement for Gastric Bypass Evaluation is an effective treatment?The available research does not provide specific data on the effectiveness of the Napoleon Measurement for Gastric Bypass Evaluation as a treatment. Instead, the studies focus on various aspects of bariatric surgery, such as surgical assessment tools, psychosocial evaluations, and outcome predictors. Without direct evidence from these studies, we cannot conclude the effectiveness of the Napoleon device compared to other treatments.78111415
What safety data exists for the Napoleon Measurement for Gastric Bypass Evaluation?The provided research does not directly mention the Napoleon Measurement for Gastric Bypass Evaluation or the Napoleon Endoscopic Measuring Device. However, it includes safety data on various obesity treatments, such as gastric bypass and intragastric balloons. For gastric bypass, the Greenville study reports a 1% operative mortality and 10% significant complications. The jejunoileal bypass study indicates a 2.1% operative lethality and 21% postoperative complications. Intragastric balloons have complications like leaks (33.4%), vomiting (26.6%), and abdominal pain (25.3%). These findings highlight the importance of evaluating safety data specific to the Napoleon device, which may not be covered in the current research.3491213
Eligibility Criteria
This trial is for Roux-en-Y gastric bypass patients aged 18-90 who have experienced weight regain and are scheduled for an endoscopy. They must be willing to consent to the study. Those with a history of complications from prior endoscopies cannot participate.Inclusion Criteria
I am willing and able to give my consent for treatment.
Exclusion Criteria
I have had complications from previous endoscopies.
Treatment Details
The Napoleon device's ability to measure the size of gastrojejunal anastomosis in gastric bypass patients is being tested against traditional visual estimation by doctors during endoscopy procedures at two hospitals.
1Treatment groups
Experimental Treatment
Group I: Roux-en-Y gastric bypass patients with weight regainExperimental Treatment2 Interventions
The study population is Roux-en-Y gastric bypass (RYGB) patients with weight regain undergoing an endoscopy at Bellevue Hospital Center or Brigham and Women's Hospital.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Brigham and Women's HospitalBoston, MA
Bellevue Hospital CenterNew York, NY
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
Brigham and Women's HospitalCollaborator
References
Comparison between subjective and objective estimates of upper pouch volume at gastric banding for obesity. [2006]Small size of the upper pouch has been considered mandatory for good weight loss after different gastric operations for extreme obesity. In most published series the estimates of upper pouch size seem to have been subjective. The present report concerns gastric banding in 18 patients, with standardized objective measurement of the upper pouch made after subjective estimation independently by two bariatrically trained surgeons. The subjective determination resulted in statistically significant underestimation compared with the objective procedure. For adequate evaluation of the surgical method, therefore, it is important to measure the pouch size objectively.
A method for measuring the size of the gastric outlet in obesity surgery. [2008]A simple method was evolved for measuring the gastric outlet size following surgery for obesity. Measurements are made through a fiberoptic endoscope, using a Fogarty catheter. A "phantom" study showed the method to be accurate and superior to endoscopic estimation without a reference balloon. High interexaminer and intraexaminer reproducibility was confirmed by independent measurements in patients.
The Greenville gastric bypass. Progress report at 3 years. [2019]Two hundred and ten morbidly obese patients underwent a standardized gastric bypass procedure between February 1980 and November 1983. We conclude, based on 100% follow-up, that the operation is safe (operative mortality--1%, significant complications--10%) and effective (reoperation rate--4%). Only one patient failed to lose more than 25% of preoperative weight. The operation produced a mean weight loss in the group from 289 pounds (202-505) before surgery to 176 pounds (118-308) at 18 months after surgery. Stated as "per cent of ideal weight," patients lost from a preoperative mean of 214% (153-350) to 130% (88-189) at 18 months. Maximum weight loss was reached by 18 months after the procedure and was maintained during 36 months of observation in over 95% of patients. When patients were divided into four groups according to preoperative weight, weight loss occurred at a roughly similar rate, but heavier patients, although they lost more weight, plateaued at a higher weight than patients originally less obese. Striking and objective benefits were seen in patients with diabetes, hypertension, heart disease, and pulmonary insufficiency.
Jejunoileal bypass versus gastric bypass or gastroplasty in the operative treatment of obesity. [2019]A comparative study has been made of three methods for the operative treatment of obesity. Of my own cases, 235 underwent a jejunoiliac bypass procedure, and the results have been analyzed: operative lethality 2.1%; postoperative complications 21%. Of the patients whose residual ileum was quite short (about 45 cm), about 70% reached their ideal weight. Metabolic late complications were considerable (e.g., liver damage in 15%, electrolyte deficit in 12%, and arthritis in 10%). In the late observation time of 14 years, 14 patients died, 10 of them as a result of the operation. Three different stomach-bypass procedures are described. The collective statistics compiled on 1585 patients indicated 1.6% postoperative lethality and 22% postoperative complications. Of the total patients. 90% were very satisfied with the procedure and in only 5% was a weight gain recorded after 5 years. The latest procedure is gastroplasty according to the Gomez method: the first 200 cases show 0.5% postoperative lethality and postoperative complications in 18.5%. Although this procedure is technically simple, the late observation time is not yet adequate for a definitive comparison.
Use of a Calibration Balloon Tube to Size the Pouch and Channel in Gastroplasty Procedures. [2019]Gastroplasty is currently one of the most common surgical procedures performed on the morbidly obese for weight loss. An adequate result can be assured only if the pouch that is created is less than 30 ml and the channel that connects that pouch to the distal stomach is approximately 1 cm in diameter. The current method to size the pouch is to occlude the esophagus and the outlet of the pouch and to measure with a manometer through a naso-gastric tube. We contend this method is both time consuming and adds to the potential of complications. Through the use of a calibration balloon tube the size of the pouch can be quickly and safely estimated. It can also be used to size the channel between the pouch and the distal stomach and check for leaks. The technique of how this tube has been used over the past 6 years is described. By the use of a calibration balloon tube, three problem areas in gastric stapling surgery for morbid obesity are avoided, namely: inappropriate pouch size, inappropriate channel size and postoperative leaks.
[Long-term management of patients after bariatric surgery]. [2016]Bariatric surgery has developed substantially in France over the past 15 years. It has numerous complications that vary according to the type of procedure. Adjustable gastric banding and gastric bypass are the most common bariatric surgery techniques in France. The adjustable gastric band is particularly subject to surgical and mechanical complications long after surgery. Early postoperative complications are more frequent after gastric bypass and generally more serious than with the gastric band. Longer after surgery, the gastric bypass has essentially nutritional complications. The role of the general practitioner is fundamental in coordinating follow-up of patients, in collaboration with the medical-surgical team that performed the operation. Long-term follow-up of patients is essential because of the risk of late complications.
Predictive factors of outcome after gastric banding: a nationwide survey on the role of center activity and patients' behavior. [2022]Systematic studies of postoperative outcome of bariatric surgery provide information on the predictors of success. Surgeon's and institution experience and patient's behavior after surgery are key determinant of success or failure. Data on clinical trials generally reflect the experience of skilled obesity surgery centers. Little is known about the current practice at a nationwide level. The present study was realized in the frame of a national survey on medical and surgical practices conducted by the public health insurance system. The objective was to analyze systematically and prospectively the outcome of all bariatric surgery procedures consecutively performed in a given period, as registered by the French National Medical Insurance Service. This study at a nationwide level focused on predictive factors of success and analyzed how the experience of the centers relates to the patients' outcomes at 1 and 2 years after surgery.
BAROS results in 700 patients after laparoscopic Roux-en-Y gastric bypass with subset analysis of age, gender, and initial body mass index. [2022]The Bariatric Analysis and Reporting Outcome System (BAROS) uses a point scale (maximal score of 9) to evaluate weight loss, complications, improvement in medical conditions, and quality of life among postoperative bariatric patients. The BAROS was originally developed to address the need for a standardized method of reporting open gastric bypass outcomes and has been shown to be both valid and reliable. BAROS scores >7 are considered "excellent." Our objective was to assess the overall BAROS scores in patients undergoing laparoscopic Roux-en-Y gastric bypass at each postoperative follow-up interval and to examine the effect of age and gender on BAROS scores.
Benefit-risk paradigm for clinical trial design of obesity devices: FDA proposal. [2021]Diet and exercise, except in controlled circumstances, have not been shown to provide effective and prolonged weight loss for the majority of those who are obese. Several older drugs intended to reduce weight have been withdrawn from the market, and the new drugs show only modest weight loss. Surgical intervention, specifically procedures that alter the normal gastrointestinal anatomy, does provide prolonged periods of sustained weight loss, with rebound weight gain over time. A variety of medical devices to assist in weight reduction have been studied, but only two are legally marketed devices for obesity. The authors propose a new paradigm for devices intended to treat obesity, based on a benefit-risk determination, with the hope to provide sponsors an a priori tool for systematic assessment of the risks associated with the devices intended for treatment of obesity and to suggest appropriate levels of benefit for devices with different risk levels. The paradigm is not intended to determine the class of a device from a regulatory perspective. This approach was conceived at a Food and Drug Administration (FDA) co-sponsored workshop in October, 2011 and formally presented to an FDA advisory panel for discussion in May 2012.
Validation of a new method for the endoscopic measurement of post-bariatric gastric outlet using a standard guidewire: an observer agreement study. [2019]Between 10 and 20% of all patients undergoing bariatric surgery procedures regain weight secondary to a gastrojejunostomy enlargement. The aim of this study was to validate the interobserver agreement while measuring gastric outlet diameters using a new standard guidewire.
The Bariatric Interprofessional Psychosocial Assessment of Suitability Scale predicts binge eating, quality of life and weight regain following bariatric surgery. [2021]Presurgical psychosocial evaluations are an important component of bariatric care; yet, bariatric programs vary widely in their assessment and interpretation of psychosocial risk. There is a need for validated clinical tools that help to standardize and streamline the assessment of variables relevant to surgical outcomes. The present study contributes to the validation of the Bariatric Interprofessional Psychosocial Assessment of Suitability Scale (BIPASS), a novel presurgical psychosocial evaluation tool, by: (a) examining the psychometric properties and optimal cutoff score, and; (b) examining the ability of the BIPASS tool to predict outcomes 1 and 2 years postsurgery, including weight regain, quality of life, psychiatric symptoms and adherence to postsurgical follow-up appointments. The BIPASS was applied retrospectively to the charts of 179 consecutively referred patients to a metropolitan bariatric surgery programme. Internal consistency for the BIPASS was acceptable, and interrater reliability was excellent. Higher BIPASS scores predicted higher binge eating symptomatology and lower mental health-related quality of life at 1 year postsurgery, and weight regain at 2 years (all P
[One-anastomosis gastric bypass with a short limb]. [2022]To develop an acceptable method of surgical treatment of patients with obesity grade 1 and 2 in accordance with the following criteria: high safety, no risk or minimal risk of intestinal malabsorption, no limitations for postoperative gastrointestinal examination, no need for organ resection and surgical reversibility in case of necessity.
Real-World Experience of Intragastric Balloons for Obesity: Insights from the FDA Manufacturer and User Facility Device Experience (MAUDE) Database. [2021]Intragastric balloons have been used to bridge the obesity treatment gap. We aim to investigate the number and type of complications associated with intragastric balloons using public-access governmental databanks. We analyzed post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from Jan 2017 through Nov 2020. During the study period, approximately 773 cases with 830 device issues and 1134 patient complications were identified. Most balloon complications were due to leaks (33.4%). The most reported adverse events were vomiting (26.6%), abdominal pain (25.3%), and nausea (15.8%). Findings from the MAUDE database highlight patient and device adverse outcomes that should be addressed to improve clinical success.
Use of the Stanford Integrative Psychosocial Assessment for Transplant as a Pre-surgical Psychological Evaluation Tool for Bariatric Surgery. [2022]How clinicians perform pre-surgical psychological evaluations (PSPE) for bariatric surgery remains variable across institutions. Bariatric PSPE guidelines state that self-report measures should be incorporated in the PSPE procedure, yet only 50-60% of PSPEs utilize patient self-report measures. Previous studies describing the presurgical psychological evaluation report a range of measures, however a gold standard in PSPE has yet to be agreed upon. Given this gap in how a presurgical psychological evaluation for bariatric patients is defined, incorporating more objective measures into this process may help clinicians identify specific areas in which a patient is struggling and benefit from additional psychosocial support. The present study proposes the use of the SIPAT, a semi-structured interview initially developed to assess organ transplant candidates, as part of this evaluation. A total of 292 adult patients underwent a pre-surgical psychological evaluation for bariatric surgery between November 2017 and February 2020 at a Midwest medical center. Patient average age was 45.2 (11.3) years and 83.3% were female. At time of analysis, 160 patients received bariatric surgery. Logistic regression and analyses of bivariate associations were conducted in R. The SIPAT exhibited good convergent validity via correlations with analogous scales on the PROMIS 43, and it yielded a small effect size predicting patients who ultimately received surgery. Accordingly, this semi-structured interview may be a useful tool to help differentiate patients for surgical candidacy.
Using video-based assessment (VBA) to document fellow improvement in safely completing the jejunojejunostomy portion of laparoscopic Roux-en-Y gastric bypass (RYGB) surgery. [2023]Surgical assessment instruments are used for formative and summative trainee evaluations. To characterize the features of existing instruments and a novel 12-item objective, procedure-specific assessment tool for Roux-en-Y Gastric Bypass (RYGB-OPSA), we evaluated the progress of a single surgical fellow over 17 consecutive surgeries.