National Bariatric Registry with OSSI(Open-label, Observational, Retrospective & Prospective, Real-time data capturing of Usage, Outcome in Bariatric & Metabolic surgery)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- To populate national data regarding bariatric surgery practice across India. This will include
研究概览
简要总结
• Informationconcerning study treatments, patent applications, formulation, manufacturingprocesses, unpublished scientific data, and other pertinent information isconfidential and remains the property of the manufacturer. Details will bedisclosed only to persons involved in the conduct of the registry. TheInvestigator may use this information for the purposes of the registry only.
• Publicationwill be made in the name of steering group and the “National Bariatric Registryâ€
• Publicationsthat have been supported in the form of funds will require, as stated inthe study agreement, to be reviewed and approved by the Publication Committeeprior to submission for publication. The review will include a check thatthere has not been any violation of obligations, and to add a disclaimer ifnecessary.
• Publicationsthat have been supported in the form of technical input or clinicalconsultation (e.g. statistical analysis, translation support, contentreview etc), will also be reviewed by the Publication Committee.
• Inthe event that a publication is to include a employee from the sponsor as anauthor, then the publication will also follow the review and approval processfor “Publications of Sponsored studies†and will go through the sponsor’sinternal review process.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 All age group of patients undergoing Bariatric & Metabolic Surgery 2 Any patient who has undergone any Bariatric & Metabolic Surgery like Sleeve Gastrectomy, Lap Gastric Bypass, Mini Gastrectomy, DJB, IT, as per operating surgeon’s discretion irrespective of their age 3 Patients undergoing bariatric& metabolic surgery in India under OSSI members.
排除标准
- •Patients operated by OSSI non-member surgeries will not be included.
结局指标
主要结局
To populate national data regarding bariatric surgery practice across India. This will include
时间窗: The data would be assessed at 1 year, 2 years, 3 years, 5 year, 10 year, 15 years, 20 years, 25 years from the start of the study
1.Patient demography
时间窗: The data would be assessed at 1 year, 2 years, 3 years, 5 year, 10 year, 15 years, 20 years, 25 years from the start of the study
2.History including BMI, co-morbidities & medical complications
时间窗: The data would be assessed at 1 year, 2 years, 3 years, 5 year, 10 year, 15 years, 20 years, 25 years from the start of the study
3.Surgical record including the type of surgery including revisions, technique, length of stay, intra-op complications, and post-operative adverse events until discharge.
时间窗: The data would be assessed at 1 year, 2 years, 3 years, 5 year, 10 year, 15 years, 20 years, 25 years from the start of the study
次要结局
- Percentage Excess weight loss(2. Quality of life questionnaire)