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临床试验/NCT07765953
NCT07765953已完成不适用

Thirteen-Year Trends in Primary Aesthetic Breast Augmentation, Implant Replacement, and Explantation: A Prospective Observational Cohort Study

Research Inc1 个研究点 分布在 1 个国家实际入组 22,642 人开始时间: 2012年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22,642
试验地点
1
主要终点
Annual and Overall Distribution of Aesthetic Breast Implant Procedure Categories

研究概览

简要总结

This prospective observational cohort study evaluated temporal trends in primary aesthetic breast augmentation, breast implant replacement, and definitive breast implant removal at IQ Interquirofanos in Medellín, Colombia. Clinical and surgical information was prospectively collected at the time of surgery in an institutional registry from January 1, 2012, through December 31, 2024.

The cohort included 22,642 unique adult participants, each of whom contributed one eligible surgical event and was classified into one of three mutually exclusive groups: primary implant placement, implant replacement, or implant removal. The primary outcome was the annual and overall distribution of these procedure categories. Secondary outcomes included breast implant volume, duration of prior implant use, indications for replacement and removal, and the relationships between participant age, implant volume, and implant duration.

Surgical procedures were selected as part of routine clinical care and were not assigned by the investigators for research purposes.

详细描述

An institutional prospective observational registry was established at IQ Interquirofanos to collect standardized clinical and surgical information and evaluate temporal trends in aesthetic breast surgery. Data included in this analysis were prospectively recorded at the time of surgery between January 1, 2012, and December 31, 2024.

The analytical cohort consisted of 22,642 unique adult participants. No participant contributed more than one surgical event. Each participant was assigned to one of three mutually exclusive procedural groups: primary aesthetic breast implant placement, breast implant replacement, or definitive breast implant removal without replacement.

Data collected included age, sex, calendar year of surgery, procedure category, right- and left-sided breast implant volumes, duration of prior implant use, and the primary recorded indication for implant replacement or removal. For replacement procedures, both prior and newly placed implant volumes were evaluated. For removal procedures, prior implant volumes were recorded.

When implant duration coexisted with another clinical or aesthetic indication for secondary surgery, the specific clinical or aesthetic indication was prioritized. "Time with implants" was recorded as the primary indication only when another specific indication was not present.

The primary outcome was the annual number and proportion of primary implant placements, implant replacements, and implant removals. Secondary outcomes included implant volumes by calendar year and procedural group, duration of prior implant use, indications for replacement and removal, and associations between age, implant volume, and implant duration.

研究设计

研究类型
观察性
观察模型
队列研究
时间视角
前瞻性

入排标准

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

入选标准

  • Participants aged 18 years or older. Participants undergoing primary aesthetic breast implant placement, breast implant replacement, or definitive breast implant removal.
  • Procedure performed at IQ Interquirofanos. Complete clinical and surgical records for the eligible procedure. Documented postoperative follow-up in the institutional record.

排除标准

  • Breast surgery performed for reconstructive indications, including postmastectomy reconstruction, congenital deformity, or trauma.
  • Mixed reconstructive and aesthetic indications. Missing core clinical or surgical variables. Absence of documented postoperative follow-up.

研究组 & 干预措施

Aesthetic Breast Implant Placement

Adult participants undergoing primary aesthetic breast surgery, removal of previously placed breast implants followed by placement of new breast implants or removal without placement of breast implants.

干预措施: Primary Aesthetic Breast Augmentation (Procedure)

Aesthetic Breast Implant Placement

Adult participants undergoing primary aesthetic breast surgery, removal of previously placed breast implants followed by placement of new breast implants or removal without placement of breast implants.

干预措施: Breast Implant Replacement (Procedure)

Aesthetic Breast Implant Placement

Adult participants undergoing primary aesthetic breast surgery, removal of previously placed breast implants followed by placement of new breast implants or removal without placement of breast implants.

干预措施: Definitive Breast Implant Removal (Procedure)

结局指标

主要结局

Annual and Overall Distribution of Aesthetic Breast Implant Procedure Categories

时间窗: yearly, each year the eligible surgical event; reported separately for calendar years 2012, 2013, 2014, 2015, 2016, 2017, 2018, 2019, 2020, 2021, 2022, 2023, and 2024

the number and percentage of eligible participants undergoing primary implant placement, implant replacement, or implant removal will be calculated for each calendar year. The numerator is the number of participants in each procedure category, and the denominator is the total number of eligible participants undergoing one of the three procedures during the corresponding calendar year. Overall counts and percentages will also be calculated across the complete observation interval. Each participant contributes one mutually exclusive surgical event.

次要结局

  • Right- and Left-Sided Breast Implant Volume by Calendar Year and Procedure Group(yearly, At the eligible surgical event; reported separately for calendar years 2012, 2013, 2014, 2015, 2016, 2017, 2018, 2019, 2020, 2021, 2022, 2023, and 2024)
  • Duration of Prior Breast Implant Use at Replacement or Removal(At the breast implant replacement or removal surgical event; eligible events occurring from January 1, 2012, through December 31, 2024. we looked for events yearly, it could be 0 years up to 15 years)
  • Distribution of Recorded Indications for Breast Implant Replacement(At the breast implant replacement surgical event; reported separately for calendar years 2012 through 2024. Yearly)
  • Distribution of Recorded Indications for Definitive Breast Implant Removal(At the definitive breast implant removal surgical event; reported separately for calendar years 2012 through 2024. Yearly)

研究者

发起方
Research Inc
申办方类型
企业
责任方
主要研究者
主要研究者

Brian Ramirez, MD, MSc

MD, Aerospace medicine, MSc, PhD(c)

Research Inc

研究点 (1)

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标识符

NCT 编号
NCT07765953
其他研究编号
004

日期

首次提交
(上个月)
首次发布
(上个月)
主要完成日期
(去年)
研究完成日期
(去年)
最近核实
(2个月前)
最近更新
(上个月)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
否
是否有结果
否

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