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临床试验/NCT03004560
NCT03004560终止不适用

Psychology of Minimally Invasive Surgical Scars

Duke University2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
32
试验地点
2
主要终点
Change in Scar satisfaction

研究概览

简要总结

The purpose of this study is to examine the psychological and psychosocial impact of surgical scars after minimally invasive surgery (MIS). 100 adult patients who are about to undergo bariatric procedures through the Duke Metabolic & Weight Loss Surgery program will be enrolled in this study. 50 patients will be randomly assigned to standard laparoscopic surgery and 50 will be assigned to the percutaneous group. All patients will complete pre-operative psychometric testing to establish a baseline body-image score as well as a patient's initial subjective perceptions around surgery and surgical scars. Follow-up visits will be done at standard of care timepoints - 3 weeks, 3 and 6 months, and 1 year after surgery. Subjects will complete the same psychometric measures to identify differences in psychological and psychosocial responses to standard laparoscopic and percutaneous scars. Patients will also complete a measure on scar satisfaction. The investigators hope to identify any differences between standard laparoscopic versus percutaneous approaches.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Body Mass Index 35 to 45
  • Undergoing Bariatric Surgery

排除标准

  • Body Mass Index <35 or >45
  • Previous Bariatric Surgery

结局指标

主要结局

Change in Scar satisfaction

时间窗: Baseline, 3 weeks, 3 months, 6 months and 1 year post-op

Patients will complete a scar assessment at post-op and routine follow up visits at 3 weeks, 3 months, 6 months, and 1 year.

次要结局

  • Change in the Abdominal pain scale(Baseline, 1 day post-op, 3 weeks, 3 months, 6 months and 1 year post-op)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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