跳至主要内容
临床试验/NCT02140385
NCT02140385撤回不适用

Role of Preservation of Scarpa's Fascia in Abdominoplasty: a Prospective Trial

Loma Linda University2 个研究点 分布在 1 个国家开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Lymphatic preservation

研究概览

简要总结

The purpose of this study is to determine whether leaving a thicker layer -which preserves the tissue called Scarpa's fascia -intact during an abdominoplasty (tummy tuck) decreases the damage to the lymphatic system.

In order to investigate the effect of leaving a thinner or slightly thicker layer intact during a tummy tuck, patients who are already planning to undergo the surgery, and who agree to participate, will be randomly assigned to two groups in a manner similar to flipping a coin. The first group will have their abdominoplasty performed with a thinner layer of abdominal wall left in place while the second group will have the surgery with a slightly thicker layer left in place. Both methods of doing a tummy tuck meet acceptable standards of care, and the aesthetic outcomes will not be negatively impacted by either of the options.

Before and after the surgery, a procedure called lymphoscintigraphy will be performed. Lymphoscintigraphy is a special type of imaging where a dye, called a radiotracer, is injected and then detected by a special camera. The pictures provided by the lymphoscintigraphy allow investigators to look at the lymphatic system, which is a small network similar to blood vessels that helps drain extra fluid. The lymphoscintigraphy will help investigators to know what method of performing the tummy tuck leaves the lymphatic system most intact.

In addition, photographs of each patient's abdomen will be taken using a special camera that allows investigators to put the photographs in the computer and compile a 3-dimensional image. Investigators will be able to look at the volume changes from swelling after the surgery using these pictures. Finally, an ultrasound will be used to help identify any seromas, or fluid collections, that may form after the surgery.

The lymphoscintigraphy, photographs and the ultrasound combined will help determine whether or not leaving a thicker or thinner layer during a tummy tuck helps preserve the fluid draining lymphatic system and whether or not that effects recovery after the procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

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

入选标准

  • all patients ages 18-65 years who are planning to undergo elective abdominoplasty

排除标准

  • patients with contraindications to lymphoscintigraphy
  • patients with contraindications to abdominoplasty
  • previous abdominal surgery or traumatic perforation

结局指标

主要结局

Lymphatic preservation

时间窗: Two weeks post-operatively

Lymphatic integrity will be measured pre-operatively and then again two weeks post-operatively in order to evaluate preservation of the lymphatic system.

次要结局

  • Edema(Up to six months post-operatively)
  • Seroma formation(Up to six months post-operatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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