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

NCT ID: NCT06498492

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-08-15

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.

Conditions

Biliary Acute Pancreatitis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Laparoscopic Cholecystectomy

Intervention Type: PROCEDURE

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

Late cholecystectomy group

Those patients whose paper came delayed were discharged after symptoms subside and were readmitted after 6 weeks to undergo laparoscopic cholecystectomy.

Laparoscopic Cholecystectomy

Intervention Type: PROCEDURE

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

Interventions

Laparoscopic Cholecystectomy

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tribhuvan University Teaching Hospital, Institute Of Medicine.

OTHER

Sponsor Role: lead

Responsible Party

Ishwor Thapaliya

Mr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ishwor Thapaliya

Kathmandu, , Nepal

Countries

Nepal

Other Identifiers

180(6-11)E2

Identifier Type: -

Identifier Source: org_study_id