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

Completed

• Conditions: Biliary Acute Pancreatitis
• Interventions: Procedure: Laparoscopic Cholecystectomy

• Registration Number: NCT06498492
• Lead Sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.

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.

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2021-02-12
• Study Completion: 2021-08-15
• Status Verified: 2024-07
• Study First Submitted: 2024-07-05
• Study First Submitted QC: 2024-07-05
• Last Update Submitted: 2024-07-05
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Late cholecystectomy group	Laparoscopic Cholecystectomy	Those patients whose paper came delayed were discharged after symptoms subside and were readmitted after 6 weeks to undergo laparoscopic cholecystectomy.
Early cholecystectomy group	Laparoscopic Cholecystectomy	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.

Primary Outcome Measures

Name	Time	Method
Total duration of hospital stay among early cholecystectomy group vs delayed cholecystectomy group	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.

Trial Locations

Locations (1)

Ishwor Thapaliya; 🇳🇵 Kathmandu, Nepal