Early Versus Delayed Laparoscopic Cholecystectomy For Acute Mild Biliary Pancreatitis: A Prospective Comparative Study
1 other identifier
observational
38
1 country
1
Brief Summary
The goal of this observational study is to evaluate the outcomes of early versus delayed cholecystectomy following mild biliary pancreatitis in Nepalese patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2021
CompletedFirst Submitted
Initial submission to the registry
July 5, 2024
CompletedFirst Posted
Study publicly available on registry
July 12, 2024
CompletedJuly 12, 2024
July 1, 2024
5 months
July 5, 2024
July 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total duration of hospital stay among early cholecystectomy group vs delayed cholecystectomy group
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.
4 weeks
Study Arms (2)
Early cholecystectomy group
For group division patients were asked to select a paper randomly from a box, offering them the choice between early or delayed laparoscopic cholecystectomy although the ultimate decision was influenced by patient preference. Those patients whose paper came early underwent early laparoscopic cholecystectomy within index hospital.
Late cholecystectomy group
Those patients whose paper came delayed were discharged after symptoms subside and were readmitted after 6 weeks to undergo laparoscopic cholecystectomy.
Interventions
Laparoscopic cholecystectomy (LC) has been established as the gold standard of treatment for acute mild biliary pancreatitis.
Eligibility Criteria
Patients diagnosed with acute mild biliary pancreatitis according to the Revised Atlanta classification 2012 were enrolled from the Emergency/Outpatient Department.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.
You may qualify if:
- Patients (\>18 years of age) who presented with the diagnosis of acute mild biliary pancreatitis in our hospital were included after obtaining written consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ishwor Thapaliya
Kathmandu, 44600, Nepal
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 4 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Mr.
Study Record Dates
First Submitted
July 5, 2024
First Posted
July 12, 2024
Study Start
September 1, 2020
Primary Completion
February 12, 2021
Study Completion
August 15, 2021
Last Updated
July 12, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available for a period of 1 year.
- Access Criteria
- Researchers must provide a clear scientific rationale for requesting the data. Data will be shared upon reasonable request to the corresponding author. Requests must detail the intended use of the data and ensure it aligns with the ethical guidelines, ensuring patient confidentiality.
Types of IPD to be Shared: Demographic data of the participants (age, gender, comorbidities). Data on the severity of biliary pancreatitis. Surgical outcomes, including the length of hospital stay, duration of surgery, and conversion rate to open cholecystectomy. Data on recurrent biliary events and perioperative complications. Groups and Time Frame: The study divided participants into two groups: Early Cholecystectomy Group: Intervention: Underwent laparoscopic cholecystectomy within a short period after diagnosis of acute mild biliary pancreatitis. Time Frame: Mean hospital stay of 5.42 ± 1.01 days. Delayed Cholecystectomy Group: Intervention: Underwent laparoscopic cholecystectomy after an extended period following the initial diagnosis. Time Frame: Mean hospital stay of 9.36 ± 1.53 days. Data Sharing Mechanism: Data will be available upon reasonable request from the corresponding author.