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临床试验/NCT04656054
NCT04656054已完成不适用

Comparing the Changes in Hemoglobin Level, Coagulopathy Profile and Electrolyte Balance in Large Volume Liposuction Patients But in Different Surface Areas.

Alaa Hassan M. Elhawary1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Comparing the sodium serum ions level pre, intra and post operative between two groups of patients, both have done large volume liposuction, with different surface areas liposuctioned.

研究概览

简要总结

What is Impact of Amount Versus Surface Area of Liposuction on Haematological Parameters, Coagulopathy Profile and Electrolyte Balance? Liposuction involves the creation of extensive subsurface trauma, comparable in many respects to the massive injury of an internal burn. Liposuction commences with cannula aspiration of several liters of fluid-engorged adipose tissue, during which small feeder vessels are inevitably torn.

Operating on multiple areas increases the area of injury regardless of whether just small amounts of fat are removed. Because many of the complications associated with large volume liposuction are related to fluid shifts and fluid balance, classifying the procedure based on the total volume removed from the patient, including fat, wetting solution, and blood, makes more sense to evaluate the damage made by the procedure.

Safety and aesthetic issues define large-volume liposuction as having a 5,000-ml aspirate, mega-volume liposuction as having an 8,000-ml aspirate, and giganto-volume liposuction as having an aspirate of 12,000 ml or more.

详细描述

Liposuction is fat- removing aesthetic surgery procedure that aims to body contouring. Liposuction is the most frequently performed aesthetic surgery procedure in Western Countries. This technique has had rapid development since the 1970s, when it was experimented for the first time by A. and G. Fischer. It is currently widely used in clinical practice for many different situations in aesthetic, reconstructive and functional fields.

At 1970s, fat removal was carried out with a blunt curette. This technique was modified in 1977 by a French surgeon, Yves Gerard Illouz, who added hyaluronidase and saline to emulsify the fatty tissue, and hence facilitate aspiration with the use of liposuction cannula. This was termed the 'wet technique' and was introduced to reduce blood loss during the procedure.

The current options for wetting solutions are dry, wet, superwet, and tumescent. The dry technique employs no wetting solution and has few indications in liposuction. The wet technique involves instillation of 200 to 300 mL of solution per area to be treated, regardless of the amount aspirated. The superwet technique employs an infiltration of 1 mL per estimated mL of expected aspirate, and this is the technique practiced at our institution. Tumescent infiltration, popularized by Klein, involves infiltration of wetting solution that creates significant tissue turgor and results in infiltration of 3 to 4 mL of wetting solution per mL aspirated. Regardless of technique, the infiltrate should be allowed to take effect for seven minutes prior to suctioning.

Most studies consider the most important parameter, to determine the safety of liposuction, is the amount (volume) of aspirated fluid. A review of the scientific literature shows that there are no scientific data available to support a specific volume maximum at which point liposuction is no longer safe, although the risk of complications is unavoidably higher as the volume of aspirate and the number of anatomic sites treated increase.

Safety and aesthetic issues define large-volume liposuction as having a 5,000-ml aspirate, mega-volume liposuction as having an 8,000-ml aspirate, and giganto-volume liposuction as having an aspirate of 12,000 ml or more.

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
25 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Female patient.
  • •Age: 25-45 years.
  • •Large volume liposuction
  • •Patient asking for liposuction or suction assisted lipoectomy.

排除标准

  • •Male patient.
  • •Age >45 or <25 years.
  • •Uncontrolled chronic diseases as DM, HTN.
  • •Show degrees of lipodystropy at breast.

结局指标

主要结局

Comparing the sodium serum ions level pre, intra and post operative between two groups of patients, both have done large volume liposuction, with different surface areas liposuctioned.

时间窗: 1 year.

To compare the impact of large volume liposuction (5 to 8 liters) from different body surface areas on the patient's electrolyte balance preoperatively, intraoperative and postoperatively. The surface area will be calculated according to Lund and Browder chart by percentage (the most accurate and widely used chart to calculate total body surface area affected by a burn injury) The volume is measured by Liters. The electrolyte, that are included in the study, is sodium ions measured by mmol/L.

Comparing the blood hemoglobin level pre, intra and post operative between two groups of patients, both have done large volume liposuction, with different surface areas liposuctioned.

时间窗: 1 year

To compare the impact of large volume liposuction (5 to 8 liters) from different body surface areas on the patient's hemoglobin level preoperatively, intraoperative and postoperatively. The surface area will be calculated according to Lund and Browder chart by percentage (the most accurate and widely used chart to calculate total body surface area affected by a burn injury) The volume is measured by Liters. Hemoglobin level is measured by g/dl.

Comparing the coagulation profile (mainly prothrombin concentration and INR) pre, intra and post operative between two groups of patients, both have done large volume liposuction, with different surface areas liposuctioned.

时间窗: 1 year

To compare the impact of large volume liposuction (5 to 8 liters) from different body surface areas on the patient's Coagulopathy Profile (prothrombin concentration, INR) preoperatively, intraoperative and postoperatively. The surface area will be calculated according to Lund and Browder chart by percentage (the most accurate and widely used chart to calculate total body surface area affected by a burn injury) The volume is measured by Liters. The coagulation profile includes mainly prothromin concentration( measured by percentage) and INR.

Comparing potassium serum ions level pre, intra and post operative between two groups of patients, both have done large volume liposuction, with different surface areas liposuctioned.

时间窗: 1 year

To compare the impact of large volume liposuction (5 to 8 liters) from different body surface areas on the patient's electrolyte balance preoperatively, intraoperative and postoperatively. The surface area will be calculated according to Lund and Browder chart by percentage (the most accurate and widely used chart to calculate total body surface area affected by a burn injury) The volume is measured by Liters. The electrolyte, that are included in the study, is potassium ions measured by mmol/L.

Comparing the blood hematocrit level pre, intra and post operative between two groups of patients, both have done large volume liposuction, with different surface areas liposuctioned.

时间窗: 1 year.

To compare the impact of large volume liposuction (5 to 8 liters) from different body surface areas on the patient's hemoglobin level preoperatively, intraoperative and postoperatively. The surface area will be calculated according to Lund and Browder chart by percentage (the most accurate and widely used chart to calculate total body surface area affected by a burn injury) The volume is measured by Liters. Hematocrit level is measured by percentage.

次要结局

未报告次要终点

研究者

发起方
Alaa Hassan M. Elhawary
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alaa Hassan M. Elhawary

Residant doctor at plastic surgery department, Assiut University hospital.

Assiut University

研究点 (1)

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