NCT06258863Enrolling By Invitation不适用
Investigating the Effects of Different Incision Types on Aesthetic Outcomes and Incision-related Complications After Breast Reconstruction Surgery
Hubei Cancer Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年7月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Breast-Q Version 2.0 Reconstruction Module
研究概览
简要总结
- DATA COLLECTION: About 300 cases of female patients who underwent breast reconstruction at Hubei Cancer Hospital(HBCH) between February 2013 and June 2023 were retrospectively collected. The incision was defined as the mastectomy incision and was grouped by the commonly used inframammary fold incision, lateral chest wall incision, circumareolar incision, and radial incision. The incidence of postoperative incision-related complications was recorded for different incision types;
- DATA ORGANIZATION: Patients were divided into subgroups based on history of previous breast surgery, location and size of the lump, retention of the nipple-areola complex, timing of reconstruction, and type of the implant. The correlation of each subgroup with incision design is discussed;
- FOLLOW-UP: Collected cases were followed up by telephone to complete the Breast-Q questionnaire (aesthetic score);
- DATA ANALYSIS: The incidence of postoperative incision-related complications and aesthetic scores for different incision types were statistically analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •total mastectomy
- •implant and/or autologous breast reconstruction.
排除标准
- •No total mastectomy
- •loss of data or loss of follow-up
- •fatal cases
结局指标
主要结局
Breast-Q Version 2.0 Reconstruction Module
时间窗: three months after surgery; six months after surgery; 1 year after surgery
The questionnaire was filled in by the subjects, and the researchers assigned scores according to the results of the questionnaire. scores of the following three parts were recorded according to the Breast-Q Version 2.0© reconstruction module, with higher scores indicating better aesthetic results, Psychosocial Well-being (0 to 100), Sexual Well-being (0 to 100), Satisfaction with Breasts (0 to 100)
次要结局
- Incision-Related Complications(within 1 year after surgery)
研究者
Xinhong Wu, PhD
Chief Physician
Hubei Cancer Hospital
研究点 (1)
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