Clinical trial NCT06498492: Early Versus Delayed Laparoscopic Cholecystectomy For Acute Mild Biliary Pancreatitis: A Prospective Comparative Study
Official title: Early Versus Delayed Laparoscopic Cholecystectomy For Acute Mild Biliary Pancreatitis: A Prospective Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Acute Pancreatitis
Keywords: Biliary Acute Pancreatitis
Laparoscopic Cholecystectomy
Outcomes
Lead sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Total duration of hospital stay among early cholecystectomy group vs delayed cholecystectomy group
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Ishwor Thapaliya
Study officials:
References: