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临床试验/NCT06083558
NCT06083558招募中不适用

Pain and Nausea in the Post-anesthesia Care Unit Following Gallbladder Surgery - a Registry Study Using National Data From Gallriks and the Swedish Perioperative Register (SPOR)

Umeå University1 个研究点 分布在 1 个国家目标入组 50,000 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50,000
试验地点
1
主要终点
Postoperative nausea and vomiting

研究概览

简要总结

The study is primarily an exploratory study of quality registry data for a swedish national cohort of patients who have undergone gallbladder surgery or ERCP, with the aim of investigating the occurrence of pain and PONV (Postoperative Nausea and Vomiting) after gallbladder surgery. Furthermore, the investigators will explorer if there are factors related to the patient or the surgical procedure that are associated with a higher risk of PONV or pain.

详细描述

The project is a registry study with linked data from the Swedish national registry for gallbladder surgery (Gallriks) and the Swedish Perioperative Register (SPOR).

In SPOR, multiple variables are recorded and the main categories include patient characteristics, process data (e.g., times, operating room, planning, cancellations), surgical data (diagnosis, procedure, anesthesia type, times, deviations), and postoperative data (e.g., pain, nausea, complications, times, postoperative care level). The main variables of interest in this project are postoperative nausea and vomiting (PONV) and pain. In SPOR, it is possible to register whether the patient experienced nausea or vomiting and to assess pain in the immediate postoperative period during the stay at the postoperative recovery unit (PACU). The mean time of stay at PACU after gallbladder surgery in Sweden is 3.5 hours.

Gallriks records data related to gallstone surgery, including preoperative factors (including patient's illness), surgical processes, and postoperative outcomes up to 6 months after surgery.

The investigators have estimated that it is possible to include at least 50% of all gallstone surgeries in Sweden, which corresponds to a range of 7,000-8,000 patients per year.

Both quality registers are housed at the Uppsala Clinical Research Center (UCR), which will perform the data linkage. The data extraction process will start with the surgical cases in Gallriks and match them with SPOR. The database delivered to the research group will contain only pseudonymized personal data, with personal identification numbers and names removed.

研究设计

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

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

  • Primary gallstone surgery
  • Adult patients (>=18 years)
  • Procedure performed between 2016 and 2025
  • Surgical procedure registered in the national quality registry Gallriks.

排除标准

  • If multiple surgeries on the same patient in the study database, subsequent procedures to the first procedure is excluded.

结局指标

主要结局

Postoperative nausea and vomiting

时间窗: Through the stay at the PACU, an average of 3.5 hours

Incidence of PONV in the postoperative ward (number of surgical cases with nausea and/or vomiting) / \[total number of surgical cases\].

Postoperative Pain

时间窗: Through the stay at the PACU, an average of 3.5 hours

Median pain score (NRS) in the postoperative ward. NRS = Numerical Rating Scale 0-10. 0 = No pain and 10 = Worst imaginable pain

Severe postoperative pain

时间窗: Through the stay at the PACU, an average of 3.5 hours

Incidence of severe pain (NRS\>=7) \[number of surgical cases with NRS\>=7\] / \[total number of surgical cases\]. NRS = Numerical Rating Scale 0-10. 0 = No pain and 10 = Worst imaginable pain

Complications after surgery

时间窗: up to 6 month

Percentage of patients with complications, unplanned hospitalizations, or reoperations after 30 days and 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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