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临床试验/NCT00831610
NCT00831610已完成不适用

Post-bariatric Abdominoplasty: Skin Sensation Evaluation.

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2006年8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
100
试验地点
2
主要终点
Innocuous static tactile sensation in grams per square millimeters (g/mm2) by nylon monofilaments aesthesiometer.

研究概览

简要总结

The purpose of this study is to quantify the skin sensation of the anterior abdominal wall of the post-bariatric patients submitted to anchor-line abdominoplasty without flap undermining.

Additional purposes were: quantify topographically the abdominal skin sensation of the Normal weight, Morbid Obese and Former Morbid Obese after bariatric surgery (before and after the abdominoplasty - excess skin surgical removal without flap undermining -> Anchor Line Abdominoplasty).

详细描述

Abdominoplasty performed in post-bariatric patients presents more post-operative complications than in non post-bariatric patients. Surgical techniques that provokes less complications are required.

Anchor-line abdominoplasty is a technique published in the years 1950 as well the first bariatric proceedings. Abdominoplasty without flap undermining is feasible in pendular abdominal wall of the former morbidly obese women with scarred abdomen.

Classical abdominoplasty (with flap undermining) is known to impair significantly the skin sensation. Post-bariatric abdominoplasty without flap undermining keeps the skin sensation unaltered since the early post-operative period.

Now that the post-bariatric anchor-line abdominoplasty improves the abdominal wall contour by removing the exceeding, pendular and striated skin saving the perforant skin sensory nerves. Could this technique improve the skin sensation of the anterior abdominal wall of the post-bariatric patients?

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
25 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Former morbidly obese women with Body Mass Index superior of 40kg/m
  • Post-bariatric surgery: Roux en Y gastric bypass.
  • Clinical conditions to perform a plastic surgery.

排除标准

  • Diabetes.
  • Peripheral neuropathy.
  • Deny to sign the Informed Consent Term.

结局指标

主要结局

Innocuous static tactile sensation in grams per square millimeters (g/mm2) by nylon monofilaments aesthesiometer.

时间窗: Day before the surgical intervention and 6th month after for Study group.

次要结局

未报告次要终点

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rodolpho Alberto Bussolaro, MD. PhD.

Doctor

Federal University of São Paulo

研究点 (2)

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