跳至主要内容
临床试验/NCT05897463
NCT05897463已完成不适用

Breast and Nipple Neurotization Via Elongation of the Lateral Cutaneous Branches Using Intercostal Branches

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年9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
75
试验地点
1
主要终点
Changes of monofilament force at 6, 12, 18, 24, and 30 months post-operatively

研究概览

简要总结

A retrospective chart review will be conducted to identify patients receiving breast reconstruction and simultaneous breast neurotization. Their reconstructed breasts will be included as study group. Patients receiving breast reconstruction without neurotization will be included as negative control group. Their contralateral normal breasts in the study and the negative control group will be included as positive control. Patients' demographic data, their breast cancer treatment parameters, such as the staging, previous radiotherapy history, postmastectomy radiotherapy, neoadjuvant and adjuvant chemotherapy will be included. The reconstruction results will be evaluated as well.

Statistics Data will be analyzed using graphing and statistical analysis software. Independent t test will be applied to calculate continuous variables in demographic values, while Chi-square will be applied to calculate categorical variables such as postoperative complications. A probability of less than 0.05 will be considered significant.

Potential risks: No

Confidentiality:

All the patient identifiable information, which includes name, chart number and birthday, involved in the study will be strictly confidential.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • patients who received breast reconstruction and neurotization from July 2019 to August 2022 from a single breast reconstruction surgeon.
  • patients who received breast reconstruction without neurotization were included as the non-neurotized group.

排除标准

  • patients unable to complete the follow-up were excluded from the study

结局指标

主要结局

Changes of monofilament force at 6, 12, 18, 24, and 30 months post-operatively

时间窗: post-operative 6, 12, 18, 24, and 30 months

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jung-Ju Huang

Associate Professor

Chang Gung Memorial Hospital

研究点 (1)

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