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临床试验/NCT07445230
NCT07445230尚未招募不适用

Metabolic Effects of Pneumoperitoneum During Laparoscopic Bariatric Surgery: Association Between Perioperative Serum Bicarbonate Change and Early Discharge Readiness

Istinye University1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2026年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
85
试验地点
1
主要终点
Perioperative Serum Bicarbonate Change (ΔHCO₃-)

研究概览

简要总结

Pneumoperitoneum during laparoscopic bariatric surgery induces carbon dioxide absorption and may lead to perioperative alterations in acid-base balance. Serum bicarbonate (HCO₃-) plays a central role in metabolic compensation; however, the clinical relevance of perioperative bicarbonate changes remains insufficiently defined.

This prospective observational study aims to evaluate the association between pneumoperitoneum duration and perioperative serum bicarbonate change (ΔHCO₃-), and to investigate whether ΔHCO₃- is associated with early discharge readiness at 48 hours (DR-48) following laparoscopic bariatric surgery. Patients undergoing laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass will be enrolled consecutively. No alteration of routine clinical care will occur.

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

  • Adults aged ≥18 years
  • ASA physical status I-III
  • Scheduled for elective laparoscopic bariatric surgery (laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass)
  • Provided written informed consent

排除标准

  • Age <18 years
  • ASA physical status IV or higher
  • Chronic obstructive pulmonary disease (COPD), asthma, or other severe chronic respiratory disease
  • Known chronic metabolic acidosis or renal failure
  • Major intraoperative complications (e.g., severe bleeding, conversion to open surgery)
  • Postoperative reoperation, intensive care requirement, or complications preventing standard recovery evaluation

结局指标

主要结局

Perioperative Serum Bicarbonate Change (ΔHCO₃-)

时间窗: From baseline (after induction, before pneumoperitoneum) to 24 hours postoperatively

Change in serum bicarbonate (HCO₃-) between the preoperative value (after induction, before pneumoperitoneum) and the postoperative 24-hour value, calculated as: ΔHCO₃- = HCO₃-(24 h postoperative) - HCO₃-(preoperative). The association between pneumoperitoneum duration (minutes) and ΔHCO₃- will be evaluated.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

İlke Dolgun

Assoc. prof

Istinye University

研究点 (1)

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