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

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

Study Overview

• Status: Completed
• Conditions: Biliary Acute Pancreatitis
• Intervention / Treatment: Procedure: Laparoscopic Cholecystectomy

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 Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Nepal
  • Kathmandu, Nepal, 44600
    • Ishwor Thapaliya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Laparoscopic Cholecystectomy; 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.	Procedure: Laparoscopic Cholecystectomy; Laparoscopic cholecystectomy (LC) has been established as the gold standard of treatment for acute mild biliary pancreatitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): February 12, 2021
• Study Completion (Actual): August 15, 2021

Study Registration Dates

• First Submitted: July 5, 2024
• First Submitted That Met QC Criteria: July 5, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 5, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Outcomes; Laparoscopic Cholecystectomy; Biliary Acute Pancreatitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: 180(6-11)E2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Data will be available for a period of 1 year.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No