Utilization of Very Low Calorie Diet in Obese General Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Reduction in Post Operative Complications
研究概览
简要总结
The investigators are studying the use of a two-week very low calorie diet (VLCD) in obese general surgery patients in a randomized single-blinded trial. The investigators hypothesize that the VLCD will positively impact the perceived surgical difficulty, operative time, hospital length of stay and 30-day complications. Additionally, the investigators anticipate reduced perioperative blood glucose levels and a reduced need for perioperative insulin administration.
详细描述
The investigators' objective for this project is to determine the impact of a preoperative VLCD on outcomes for patients undergoing elective general surgery. Included are patients who are obese, BMI >30, and scheduled by a Christiana Care-employed general surgeon for elective general surgery. Eligible patients are those scheduled for elective cholecystectomy, ventral or incisional hernia, umbilical hernia, and inguinal hernia surgery.
The investigators will also be determining the feasibility of introducing a preoperative VLCD for patients undergoing elective general surgery in a Community Hospital setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
The operative surgeons will be blinded to the randomization. The patient, by nature of the study, will not be blinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are obese, BMI >30, and scheduled by a Christiana Care-employed general surgeon for elective general surgery.
- •Patients between the ages of 18 and
- •Patients scheduled for elective cholecystectomy, ventral or incisional hernia, umbilical hernia, and inguinal hernia surgery.
排除标准
- •Patients will be excluded from the study if they have any of the following:
- •Recent myocardial infarction (3-6 months).
- •History of cerebral vascular accident (stroke).
- •Diabetes mellitus with a history of severe ketoacidosis.
- •Patients on SGLT2 inhibitors (glifozins) without insulin
- •Chronic use of steroids, greater than 20mg daily.
- •Bleeding peptic ulcer (unless there is radiological evidence of healing 6 months prior to entry).
- •A psychiatric history that includes suicide attempts and anyone taking psychotropic drugs, including lithium carbonate.
- •Active thrombophlebitis (or any other condition where decreased blood volume would put the patient at risk).
- •In addition, patients who are pregnant are excluded. If status is unknown, a pregnancy test will be required prior to the start of the VLCD.
结局指标
主要结局
Reduction in Post Operative Complications
时间窗: 30-days post operatively
Pulmonary, cardiac and surgical complications using data collected from inpatient and outpatient charting
次要结局
- Feasibility of the Study(2 weeks)
- Effect on Perioperative BMI(2 weeks)
- Effect on operative times(Day of surgery)
- Effect on blood glucose levels(2 weeks)
- Effect on surgeon perceived difficulty(Day of surgery)
- Effect on operative blood loss(Day of surgery)
- Effect on insulin administration(2 weeks)