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临床试验/NCT04235829
NCT04235829已完成不适用

Predicting Weight Loss and Comorbid Improvement Early Post-operative Weight Loss Fails to Predict Outcomes 7 Years Following Laparoscopic Sleeve Gastrectomy: Does Early Weight Loss Matter

Shaare Zedek Medical Center1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2012年4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
156
试验地点
1
主要终点
Correlation between early % total weight loss and % total weight loss 7 years following surgery.

研究概览

简要总结

A study to explore the relationship between early weight loss in the 4 weeks following laparoscopic sleeve gastrectomy and outcomes, in terms of weight loss and comorbidity improvement, 7 years following the surgery.

详细描述

Patients who underwent laparoscopic sleeve gastrectomy in the 6 month period between 01/04/2012 and 01/10/2019 were identified. For those meeting the inclusion criteria, demographic and medical data was extracted from hospital notes. This included initial BMI and the presence of, or treatment for, diabetes or hypertension.

Using the contact details available in the medical records, a scripted telephone interview was performed. The current weight of the patient as well as a current medical and drug history were elicited. This data was compared with data attained during initial patient interaction with the service.

Early weight loss, defined as weight lost in the 4 weeks following surgery, was subsequently correlated with outcomes in terms of weight loss and improvement/resolution of either hypertension or diabetes at a 7 year follow up interval.

研究设计

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

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

  • LSG performed must have been the first surgical procedure performed for that the patient had undergone to treat their obesity
  • Have not undergone any further bariatric surgical procedures since the index operation
  • Still be alive at the time of the study
  • Have correct be contactable with the contact details present available in the electronic database

排除标准

  • Missing data
  • Uncontactable
  • Unwilling to participate

结局指标

主要结局

Correlation between early % total weight loss and % total weight loss 7 years following surgery.

时间窗: A comparison made between 4 weeks and 7 years following the index surgery.

A correlation between % total weight loss 4 weeks following surgery and % total weight loss at 7 years follow up based on clinic measurements.

次要结局

  • Reduction or cessation in the treatment for either type 2 diabetes mellitus and hypertension 7 years following surgery..(A comparison was made between pre-operative medical / medication histories and equivalent data at 7 years follow up.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Tankel

Resident in General Surgery

Shaare Zedek Medical Center

研究点 (1)

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