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临床试验/NCT06284356
NCT06284356已完成不适用

Pan Immune Inflammation Value for Determining Perioperative Complications of Laparoscopic Sleeve Gastrectomy: A Prospective Cohort Study

Kahramanmaras Sutcu Imam University1 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2022年5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
159
试验地点
1
主要终点
Complication prediction after LSG with complete blood cell parameters

研究概览

简要总结

Morbid obesity emerges as a problem that causes serious complications and increased mortality rates. The most effective treatment for morbid obesity today is surgical treatment. The most preferred type of surgery in morbid obesity surgery in Turkey and around the world is Laparoscopic Sleeve Gastrectomy (LSG).

While postoperative complications are divided into early and late complications, complications that develop during surgery and in the postoperative period before discharge are defined as perioperative complications. Early surgical complications after LSG include complications such as staple line bleeding, leaks, pulmonary thromboembolism, and torsion of the remnant stomach. It is important to detect these complications, which can be controlled with early intervention in the perioperative period.

Monitoring blood parameters and monitoring inflammation are methods that are easily accessible and provide rapid evaluation. Platelet lymphocyte ratio (PLR) and neutrophil-lymphocyte ratio (NLR), which are used in the evaluation and detection of postoperative complications, have shed light on studies in this direction. Pan immune inflammation value (PIV) is calculated from blood parameters and has been used to evaluate prognosis and chemotherapy results in colorectal cancer.

In this study, the diagnostic importance of changes in NLR, PLR, and PIV values in the preoperative and postoperative periods will be investigated in detecting complications that develop in the perioperative period before discharge in patients who underwent LSG.

详细描述

Patients who will undergo LSG due to morbid obesity will be included in the study. Patients who are completely healthy, not morbidly obese, and have no additional disease will be taken as the control group. Reference range values will be obtained by taking a complete blood count from the control group once. From patients who will undergo LSG, routine pre-operative complete blood count values, and postoperative 24th-hour complete blood count values will be taken. PLR, NLR, and PIV will be calculated manually from these complete blood count samples and the change in these parameters will be evaluated between patients who develop complications and those who do not.

In descriptive statistics, categorical data will be given as number (n) and percentage (%). Numerical data will be given as mean ± standard deviation (SD) (minimum-maximum data) or median (25% - 75% values) depending on their compliance with normal distribution. The Kolmogorov-Simirnov test will be used to determine the distribution of normality. A p-value <0.05 is accepted as statistically significant.

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

入选标准

  • Completely normal, healthy individuals with no additional diseases and BMI values of 19-24 kg/m2 for the control group
  • Older than 18 years who will undergo Laparoscopic Sleeve Gastrectomy
  • Patients with a body mass index (BMI) value ≥ 40 kg/m2 and no known comorbidities
  • Patients with a BMI value ≥ 35 kg/m2 and additional comorbid diseases (such as Diabetes, Hypertension, Asthma, and Chronic Obstructive Pulmonary Disease)

排除标准

  • Individuals under 18 years of age and morbid obesity patients
  • Patients who indicate elective surgery due to morbid obesity and who are planning for non-LSG morbid obesity surgery
  • Patients who do not want to participate in the study
  • Patients with additional diseases such as concurrent malignancy or rheumatological disease

结局指标

主要结局

Complication prediction after LSG with complete blood cell parameters

时间窗: 2022-2023

Blood sample changes after LSG with complete blood cell parameters

次要结局

未报告次要终点

研究者

发起方
Kahramanmaras Sutcu Imam University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet Buğra Bozan

Professor, Associate

Kahramanmaras Sutcu Imam University

研究点 (1)

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