Clinical Trials Directory

Trials / Completed

CompletedNCT06498492

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

Status
Completed
Phase
Study type
Observational
Enrollment
38 (actual)
Sponsor
Tribhuvan University Teaching Hospital, Institute Of Medicine. · Academic / Other
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDURELaparoscopic CholecystectomyLaparoscopic cholecystectomy (LC) has been established as the gold standard of treatment for acute mild biliary pancreatitis.

Timeline

Start date
2020-09-01
Primary completion
2021-02-12
Completion
2021-08-15
First posted
2024-07-12
Last updated
2024-07-12

Locations

1 site across 1 country: Nepal

Source: ClinicalTrials.gov record NCT06498492. Inclusion in this directory is not an endorsement.