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临床试验/NCT07473583
NCT07473583招募中不适用

Association Between Pneumoperitoneum Duration and Changes in Serum Bicarbonate Levels in Patients Undergoing Laparoscopic Inguinal Hernia Repair: A Prospective Observational Study

Haseki Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Change in Serum Bicarbonate Level

研究概览

简要总结

The goal of this observational study is to learn how the length of pneumoperitoneum during laparoscopic inguinal hernia surgery may affect changes in blood bicarbonate levels. Pneumoperitoneum is the use of carbon dioxide gas to create space inside the abdomen during laparoscopic surgery.

The main question this study aims to answer is whether a longer pneumoperitoneum time is associated with changes in blood bicarbonate levels after surgery.

Participants are adults undergoing laparoscopic inguinal hernia repair as part of their routine medical care. Researchers will measure blood gas values, including bicarbonate levels, before surgery and again two hours after surgery. The change in bicarbonate levels will be compared with the duration of pneumoperitoneum during the operation.

The results of this study may help improve the understanding of metabolic changes that occur during laparoscopic surgery.

详细描述

Carbon dioxide pneumoperitoneum is routinely used during laparoscopic surgery to provide adequate visualization and working space. However, absorption of carbon dioxide and increased intra-abdominal pressure may influence acid-base balance during the perioperative period. These physiological changes may be reflected in blood gas parameters such as pH, partial pressure of carbon dioxide (pCO2), and serum bicarbonate levels.

This prospective observational study aims to evaluate the relationship between pneumoperitoneum duration and perioperative changes in serum bicarbonate levels in patients undergoing laparoscopic inguinal hernia repair using the transabdominal preperitoneal (TAPP) technique.

Adult patients undergoing elective laparoscopic inguinal hernia repair will be included in the study. Blood gas measurements will be obtained before surgery and at the second postoperative hour. Serum bicarbonate levels will be recorded, and the difference between preoperative and postoperative measurements (ΔHCO3-) will be calculated.

The primary outcome of the study is the change in serum bicarbonate levels between the preoperative and postoperative second-hour measurements. Secondary outcomes include postoperative pain scores, postoperative acid-base parameters such as pH and pCO2, and early postoperative complications within the first 24 hours.

Pneumoperitoneum duration will be recorded intraoperatively and analyzed for its association with perioperative metabolic changes. The findings of this study may contribute to a better understanding of metabolic alterations occurring during laparoscopic surgery and their potential clinical implications.

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

  • Age ≥18 years
  • Patients undergoing laparoscopic inguinal hernia repair using the TAPP technique
  • Ability to provide informed consent

排除标准

  • Pregnancy
  • Severe cardiovascular disease
  • Renal insufficiency
  • Patients requiring additional intra-abdominal surgical procedures
  • Strangulated inguinal hernia requiring bowel resection

研究组 & 干预措施

Laparoscopic Inguinal Hernia Patients

Adult patients undergoing laparoscopic inguinal hernia repair (TAPP). Pneumoperitoneum duration and perioperative serum bicarbonate changes will be analyzed using blood gas measurements obtained preoperatively and at the second postoperative hour.

干预措施: Laparoscopic Inguinal Hernia Repair (TAPP) (Procedure)

结局指标

主要结局

Change in Serum Bicarbonate Level

时间窗: Preoperative to postoperative 2 hours

Difference between preoperative and postoperative second-hour serum bicarbonate levels measured by blood gas analysis in patients undergoing laparoscopic inguinal hernia repair. Unit of Measure: mmol/L

次要结局

  • Postoperative Pain Score(Within 24 hours after surgery)
  • Change in Arterial Blood pH(Preoperative to postoperative 2 hours)
  • Early Postoperative Complications(Within 24 hours)
  • Change in Arterial Partial Pressure of Carbon Dioxide(Preoperative to postoperative 2 hours)

研究者

发起方
Haseki Training and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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