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临床试验/NCT07051759
NCT07051759尚未招募不适用

Assessment of Back Rolls and Algorithm of Management

Hager Montaser Sayed Bedeer0 个研究点目标入组 30 人开始时间: 2025年7月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
主要终点
improvement in grading of back rolls

研究概览

简要总结

"Back Rolls" are basically fat deposits on the back in the form of rolls. This is a common problem in women, and concerns were encountered by cosmetic surgeons the worldwide. Deep connective tissue in the back attachments to the underlying muscle and/or periosteum divide the fat deposits on the back into multiple visual compartments. Their nomenclature is based on the anatomical area from where they have originated. The skin-fat envelope is held in place by facial attachments that are named the "zones of adherence".

The extent of fat deposits and number of back rolls, as well as skin laxicity, varies from person to person and also from one side to the other. The rolls surely have a zone of adherence inferiorly over which the tissue fold hangs and medially in the midline. Treatment modalities for back rolls depend on the above-mentioned variables and involve three general approaches:

  1. Suction-assisted Liposuction along alone or with other modalities of skin tightening as VASER or J-Plasma ;
  2. Direct surgical excision of the skin fold as an upper back lift.
  3. Non- surgical: Injection lipolysis in association with weight loss. The choice of treatment depends on the specific characteristic of the back roll; hence, a classification to grade the extent of back roll would help in guiding the surgeon to choose the best possible option.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Female patients aged 18 to 50 years old.
  • •Any grad of back rolls

排除标准

  • •patients outside the selected age range
  • •Abnormal laboratory tests (in particular, glucose >105 g/dL, hemoglobin <12 g/dL, platelets <150,000)
  • •significant systemic diseases.
  • •previous liposuction or other back surgeries.

研究组 & 干预措施

patients with back rolls who undergo the back contouring surgery

Experimental

干预措施: Back contouring surgery (Procedure)

结局指标

主要结局

improvement in grading of back rolls

时间窗: six months postoperative

Grade I: Back rolls that appear when the arms are kept by the side and disappear when the arms are raised. Grade II: Back rolls having a single indentation (partial or complete) that reduces when the arm is raised. Grade III: Back rolls with two or more skin indentations with skin pinch of more than 2 cm. The skin fold should not be lower than the inferior tethering point. Grade IV: Back rolls secondary to massive weight loss that have multiple folds with skin pinch less than 2 cm and skin fold lower than the tethering point, or in patients who have undergone prior surgical treatment.

Compare the improvement of waist-hip ratio

时间窗: six months postoperative

The waist-hip ratio (WHR) is a measurement that compares the circumference of your waist to the circumference of your hips. It's calculated by dividing the waist measurement by the hip measurement.

Compare the improvement of waist-chest ratio

时间窗: six months postoperative

The waist-chest ratio is a measurement that compares a person's waist circumference to their chest circumference. It's often used as an indicator of body shape and potential health risks associated with fat distribution.

次要结局

未报告次要终点

研究者

发起方
Hager Montaser Sayed Bedeer
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hager Montaser Sayed Bedeer

Principal Investigator

Assiut University

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