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临床试验/NCT06649578
NCT06649578已完成不适用

Comparing Bariatric Surgery Outcomes in Predominantly High-Risk Asian Patients to Global Benchmarks: Insights From a Decade-Long Cohort Study of 1016 Patients

National University Hospital, Singapore1 个研究点 分布在 1 个国家目标入组 1,016 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,016
试验地点
1
主要终点
Number of Participants with Anastomotic Leak

研究概览

简要总结

While metabolic-bariatric surgery is a safe and well-established surgery, complications do occur and can have significant impact on the patient. With the study, the investigators aim to establish the proportion of patients that will have complications and understand what the impact of complications are on costs.

详细描述

Complications after metabolic-bariatric surgery can be catastrophic and have significant impact on costs, morbidity, and mortality. As current global benchmarks for complications rates in MBS are based on standard risk patients in western populations, the benchmark complication rates in high-risk patients and Asian populations are unknown. The investigators aim to evaluate the incidence of complications in 1016 consecutive patients and the impact of complications on costs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The inclusion criteria were patients who underwent either primary or revisional MBS comprising Laparoscopic Sleeve Gastrectomy (LSG), Roux-en-Y Gastric Bypass (RYGB) or One-Anastomosis Gastric Bypass (OAGB).

排除标准

  • Patients under 18 years old

结局指标

主要结局

Number of Participants with Anastomotic Leak

时间窗: From completion of surgery till post-operative 90 days

90 Day Post-Operative Complications

Number of Participants with Bleeding

时间窗: From completion of surgery till post-operative 90 days

90 Day Post-Operative Complications

Number of Participants with Perforation

时间窗: Time Frame: From completion of surgery till post-operative 90 days

90 Day Post-Operative Complications

Number of Participants with Collection

时间窗: Time Frame: From completion of surgery till post-operative 90 days

Collection includes hematoma, pus, serous fluids. Outcome measured to 90 Day Post-Operative.

Number of Participants with Hospital Readmission

时间窗: From completion of surgery till post-operative 90 days

Any readmission to hospital from completion of surgery till post-operative 90 days

Number of Participants with Reoperation

时间窗: From completion of surgery till post-operative 90 days

Any reoperation due to any complications from completion of surgery till post-operative 90 days

次要结局

  • Total Costs of Bariatric Surgery (USD)(From completion of surgery till post-operative 90 days)
  • Time to surgical intervention (hr)(From completion of surgery till 90 days post-operative)
  • Number of Participants with Total Parental Nutrition Requirement(From completion of surgery till post-operative 90 days)
  • Number of Participants with Blood Transfusion(From completion of surgery till post-operative 90 days)
  • Length of Stay (Days)(From completion of surgery till hospital discharge assessed up to post-operative 90 days)
  • Number of Participants with Emergency Department Attendance(From completion of surgery till post-operative 90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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