跳至主要内容
临床试验/NCT06498492
NCT06498492已完成不适用

Early Versus Delayed Laparoscopic Cholecystectomy For Acute Mild Biliary Pancreatitis: A Prospective Comparative Study

Tribhuvan University Teaching Hospital, Institute Of Medicine.1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
1
主要终点
Total duration of hospital stay among early cholecystectomy group vs delayed cholecystectomy group

研究概览

简要总结

The goal of this observational study is to evaluate the outcomes of early versus delayed cholecystectomy following mild biliary pancreatitis in Nepalese patients.

详细描述

This was a hospital-based prospective observational study performed at a tertiary academic center from September 2020 to August 2021.

Patients diagnosed with acute mild biliary pancreatitis according to the Revised Atlanta classification 2012 were enrolled from the Emergency/Outpatient Department. Detailed history taking and thorough general and systemic examinations were conducted. Eligible patients were informed about treatment options (early vs. delayed LC) and provided informed written consent. Randomization into "early" or "delayed" groups was performed, and detailed investigations were conducted. To avoid bias, randomization was accomplished by lottery method. In the early group, laparoscopic cholecystectomy was performed during the same admission, while delayed group patients underwent surgery after symptom resolution and readmission. Surgeries were performed under general anesthesia with standard laparoscopic techniques with surgeons of equivalent qualifications. Postoperative care included analgesics and antibiotics, with follow-up examinations and histopathological assessments conducted at specified intervals. Oral intake and pain management protocols were implemented postoperatively, with patients monitored for recovery and instructed to return to normal activities after staple removal. Patients were asked to complete a visual analog pain score (VAS) from 0 (no pain) to 10 (intolerable pain) on the seventh postoperative day.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients (>18 years of age) who presented with the diagnosis of acute mild biliary pancreatitis in our hospital were included after obtaining written consent

排除标准

  • patients with severe sepsis, acute moderate and severe pancreatitis, immunocompromised conditions, biliary peritonitis, cholangitis, pregnancy, admission to the intensive care unit (ICU) or high dependency unit (HDU) and those who declined to provide consent.

结局指标

主要结局

Total duration of hospital stay among early cholecystectomy group vs delayed cholecystectomy group

时间窗: 4 weeks

In the early group, the time interval between admission to the day of discharge following laparoscopic cholecystectomy was taken into account. In the delayed group, total duration of hospital stay in conservative management period as well as for laparoscopic cholecystectomy was taken into account.

次要结局

未报告次要终点

研究者

发起方
Tribhuvan University Teaching Hospital, Institute Of Medicine.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ishwor Thapaliya

Mr.

Tribhuvan University Teaching Hospital, Institute Of Medicine.

研究点 (1)

Loading locations...

相似试验