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临床试验/NCT05654571
NCT05654571尚未招募不适用

Evaluation of the Relationship Between Weight Loss and Breast Cancer After Laparoscopic Sleeve Gastrectomy Surgery

Fatih Sultan Mehmet Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
1
主要终点
breast cancer incidence after laparoscopic sleeve gastrectomy

研究概览

简要总结

Obesity is an important risk factor for postmenopausal breast cancer. A large meta-analysis concluded that obesity is associated with a 20% to 40% increased risk for receptor-positive postmenopausal breast cancer. The International Agency for Research on Cancer working group on obesity and cancer risk drew similar conclusions. Obesity seems to have the opposite effect among premenopausal women, with most studies suggesting that higher BMI is associated with a reduced risk of premenopausal breast cancer.

Determining whether deliberate weight loss is associated with a reduced risk of breast cancer is difficult in part because sustained weight loss is difficult to achieve and few studies have sufficient statistical power to address this question. Bariatric surgery is one of the few weight loss interventions in which significant weight loss is maintained. A limited number of previous studies have suggested a reduced risk of cancer following bariatric surgery. Recently, it showed that bariatric surgery is associated with a lower risk of several types of cancer, including an approximately 40 % reduction in the risk of postmenopausal breast cancer. However, whether bariatric surgery affects breast cancer risk in premenopausal women and whether this association is altered by estrogen receptor (ER) status has not been addressed.

The aim of this study is to examine the relationship between weight loss after laparoscopic sleeve gastrectomy (LSG) and breast cancer.

详细描述

In this study, 300 female patients who underwent laparoscopic sleeve gastrectomy due to morbid obesity in Fatih Sultan Mehmet Training and Research Hospital General Surgery Clinic will be included. The number of samples was calculated by performing impact power analysis.

Mamagrophy is recommended for all women over the age of 40 as part of the routine cancer screening program in our country. For this reason, it is assumed that female patients over the age of 40 who have undergone LSG operation have undergone mammography as of 2022. For this reason, the data of these patients will be examined by scanning from the hospital system. Patients who have undergone mammography examination at least 3 years after the LSG operation will be included in the study. The mammograms of the patients who underwent mammography in January 2015 and later will be evaluated. The final diagnosis of breast cancer will be made with the pathology result in patients with suspicious appearance on mamagrophy.

If there is a malignancy detected as a result of the examinations, its size and pathology will be recorded. Patients' age, gender, and total weight loss will be recorded.

In this retrospective study, we aimed to determine the incidence of breast cancer in patients who had undergone LSG surgery and also to determine whether there was a change in breast cancer compared to weight loss.

The patient inclusion criteria are as follows:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 40 years and older (age as of 2022, not the age of operation)
  • LSG was applied in our clinic due to morbid obesity.
  • Patients whose mamagrofi images are available in the hospital system

排除标准

  • Patients who underwent abdominal surgery again after LSG
  • Patients whose mamagrophy image is not in the system
  • Patients with suspicious findings as a result of mammography and who did not undergo additional imaging or biopsy
  • Patients out of follow-up after the operation

结局指标

主要结局

breast cancer incidence after laparoscopic sleeve gastrectomy

时间窗: 5 year

Comparison of breast cancer incidence in those who lost weight after laparoscopic sleeve gastrectomy and those who did not.

次要结局

  • breast cancer incidance(5 year)

研究者

发起方
Fatih Sultan Mehmet Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

ANIL ERGIN

Uzman Doktor

Fatih Sultan Mehmet Training and Research Hospital

研究点 (1)

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