Eligibility Criteria for Cholecystectomy in Ambulatory Surgery
Cold laparoscopic cholecystectomy is the gold standard for the management of symptomatic vesicular stones. There is considerable controversy as to whether it should be practiced in outpatient surgery or as part of inpatient surgery, regarding to patient safety.
"Minor" surgical procedures, such as anal surgery or simple inguinal hernia interventions, were initially considered eligible for an outpatient procedure. Advances in surgical techniques, anesthesia and early rehabilitation have also made it possible to consider more "heavy" interventions, such as cholecystectomy.
The aim of this study is to identify eligible patients for laparoscopic cholecystectomy in outpatient surgery, taking surgical criteria into account.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
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Brussels、比利时、1020
- CHU Brugmann
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients who have had a laparoscopic cholecystectomy with a single cholecystectomy procedure without other associated interventions (bariatric surgery or other)
Exclusion Criteria:
- Pregnant women
- Diabetic patients under insulin treatment
- History of major abdominal surgery
- Acute cholecystitis as per anatomo-pathological examination
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Cholecystectomy
Patients with a symptomatic vesicular lithiasis, having undergone cholecystectomy during a scheduled hospitalization in the CHU Brugmann Hospital between May 2016 and November 2017.
|
Cholecystectomy
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Surgery duration
大体时间：Up to 4h
|
Duration of the surgical intervention
|
Up to 4h
|
|
Post surgical pain
大体时间：Up to 1 day after surgery
|
Pain killer medication administered post surgery, expressed in mg
|
Up to 1 day after surgery
|
|
Nausea
大体时间：Up to 1 day after surgery
|
Occurence of nausea or vomiting post surgery
|
Up to 1 day after surgery
|
|
Post surgery hospitalization duration
大体时间：Up to 10 days after surgery
|
Post surgery hospitalization duration
|
Up to 10 days after surgery
|
|
Medical complications after surgery
大体时间：Up to 1 year after surgery
|
Medical complications after surgery
|
Up to 1 year after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Data extraction from medical files: medical history
大体时间：5 min
|
Important surgical or medical antecedents of the patient before surgery (data extraction from medical file).
|
5 min
|
|
Physical status score
大体时间：5 min
|
Physical status score (also called ASA score for American Society of Anesthesiologists score) of the patient before surgery.
The ASA score ranges from I (normal healthy patient) to VI (declared brain-dead patient whose organs are being removed for donor purposes)
|
5 min
|
|
Body mass index
大体时间：5 min
|
Body mass index of the patient before surgery
|
5 min
|
|
Hospitalisation type
大体时间：Up to 10 days after surgery
|
Same day (ambulatory) or not
|
Up to 10 days after surgery
|
|
Type of surgery
大体时间：Up to 4 hours
|
Surgery performed under nuclear magnetic resonance (RMN) or RMN + endoscopic retrograde cholangiography (CWR)
|
Up to 4 hours
|
合作者和调查者
调查人员
- 首席研究员：Levon HAKOBYAN、CHU Brugmann
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- CHUB-cholecystectomy
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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