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临床试验/NCT02572271
NCT02572271已完成不适用

Mastopexy With Autologous Augmentation in Women After Massive Weight Loss - A Clinical, Randomized Study

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Operation Time

研究概览

简要总结

The purpose of this study is to compare two different techniques of mastopexy with autologous augmentation, the Lower Pole Subglandular Advancement Mastoplasty (LOPOSAM) and Rubins Mastopexy with autologous augmentation, in massive weight loss patients to see if one technique is superior to the other.

详细描述

In Massive Weight Loss (MWL) patients the breasts often appear deflated following the prominent volume decrease. The breast is not only deflated, the supportive fibrous tissue is lax and the structural properties have changed. In the typical patient the breast base has sunk along with the inframammary crease and the shape of the breast is wide and flat with a significant ptosis.

One way of helping these women is to offer a mastopexy with autologous augmentation. There are several different surgical techniques for treating the ptotic and deflated breast in MWL patients.

In this study the investigators compare the investigators own technique, LOPOSAM, with Rubins Mastopexy with autologous augmentation.

In Rubins Mastopexy, an extensive re-arrangement of the skin, fat and breast tissue is done and this is supposed to give good long term results. The procedure is however time consuming and extensive.

The LOPOSAM technique is less extensive and therefore less time consuming and the investigators hypothesis is therefore that the technique has a lower complication rate.

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women that meet the Danish National Board of Health criteria for post bariatric surgery, and is found to be a suitable candidate for autologous augmentation

排除标准

  • Severe dementia, making informed consent impossible
  • Non-Danish speaking

结局指标

主要结局

Operation Time

时间窗: Intraoperative

The time of surgery from start to finish is registered for both techniques.

次要结局

  • Complications(3 months)
  • Cosmetic result(1 year)
  • Costs of treatment(1 year)
  • Breast measurements(1 year)

研究者

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

Peder Ikander

MD

Odense University Hospital

研究点 (2)

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