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临床试验/NCT07747168
NCT07747168进行中(未招募)不适用

The Predictive Value of Nutritional and Inflammatory Indices for Postoperative Complications in Bariatric Surgery Patients: A Single-Centre Retrospective Cohort Study

G.Gennimatas General Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2023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
进行中(未招募)
发起方
入组人数
600
试验地点
1
主要终点
30-Day Postoperative Complications (Clavien-Dindo Grade II or Higher)

研究概览

简要总结

Bariatric surgery is an effective treatment for severe obesity, but postoperative complications remain an important cause of morbidity. Several nutritional and inflammatory biomarkers derived from routine preoperative blood tests have been proposed as predictors of postoperative outcomes; however, their comparative value in bariatric surgery has not been fully established.

This single-center retrospective cohort study will evaluate the ability of preoperative nutritional and inflammatory indices, including the Prognostic Nutritional Index (PNI), Neutrophil-to-Lymphocyte Ratio (NLR), Platelet-to-Lymphocyte Ratio (PLR), Systemic Immune-Inflammation Index (SII), Systemic Inflammation Response Index (SIRI), and C-reactive Protein-to-Albumin Ratio (CAR), to predict 30-day postoperative complications following bariatric surgery. The study aims to identify the most clinically useful biomarker for preoperative risk stratification and optimization of perioperative care.

详细描述

Bariatric surgery is the most effective treatment for severe obesity and obesity-related comorbidities. Despite advances in perioperative care, early postoperative complications continue to contribute to patient morbidity and healthcare utilization. Reliable preoperative risk stratification tools are therefore essential for identifying patients at increased risk and optimizing perioperative management.

Nutritional status and systemic inflammation have emerged as important determinants of surgical outcomes. Several composite indices calculated from routinely available laboratory parameters, including albumin, C-reactive protein, leukocyte subsets, and platelet counts, have demonstrated prognostic value in different surgical populations. However, evidence regarding their comparative predictive performance in bariatric surgery remains limited.

This single-center retrospective cohort study will include consecutive adult patients who underwent sleeve gastrectomy or gastric bypass procedures between 2023 and 2026. Preoperative nutritional and inflammatory indices (PNI, NLR, PLR, SII, SIRI, and CAR) will be calculated from the most recent preoperative laboratory values.

The primary outcome is the occurrence of any Clavien-Dindo grade II or higher postoperative complication within 30 days after surgery. Secondary outcomes include the Comprehensive Complication Index (CCI), length of hospital stay, intensive care unit admission, and 30-day mortality. Multivariable regression analyses will be performed to determine the independent predictive value of each index after adjustment for relevant demographic and clinical variables.

The findings of this study are expected to improve preoperative risk assessment and facilitate identification of patients who may benefit from targeted perioperative optimization strategies.

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
All
接受健康志愿者

入选标准

  • Adults aged 18 years or older.
  • Patients who underwent bariatric surgery (sleeve gastrectomy, Roux-en-Y gastric bypass, SADI, or SASI).
  • Availability of complete preoperative laboratory data required for calculation of nutritional and inflammatory indices.
  • Availability of postoperative follow-up data for assessment of 30-day complications.

排除标准

  • Patients younger than 18 years.
  • Missing key preoperative laboratory values required to calculate study indices.
  • Incomplete medical records or unavailable 30-day postoperative outcome data.

研究组 & 干预措施

Bariatric Surgery Cohort

Adult patients who underwent bariatric surgery (sleeve gastrectomy or gastric bypass procedures including Roux-en-Y gastric bypass, SADI, and SASI) between 2023 and 2026. Preoperative nutritional and inflammatory indices were evaluated for their association with 30-day postoperative complications.

干预措施: Bariatric Surgery (Procedure)

结局指标

主要结局

30-Day Postoperative Complications (Clavien-Dindo Grade II or Higher)

时间窗: 30 days after surgery

Occurrence of any postoperative complication classified as Clavien-Dindo grade II or higher within 30 days after bariatric surgery.

次要结局

  • Comprehensive Complication Index (CCI)(30 days after surgery)
  • Length of Hospital Stay(From surgery until hospital discharge (up to 30 days))
  • From surgery until hospital discharge (up to 30 days)(30 days after surgery)

研究者

发起方
G.Gennimatas General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Panagiotis Chatzistavridis

Resident Anesthesiologist MD PHDc , Clinical Pharmacologist

G.Gennimatas General Hospital

研究点 (1)

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