Does Subtotal Cholecystectomy Rate for Acute Cholecystitis Change With a Previous ERCP?

Completed

• Conditions: Cholecystectomy, Laparoscopic; Cholangiopancreatography, Endoscopic Retrograde
• Interventions: Procedure: ERCP

• Registration Number: NCT05728073
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Brief Summary

Study is designed to investigate whether the history of ERCP is associated with subtotal cholecystectomy rates in patients underwent laparoscopic cholecystectomy operations with the diagnosis of acute cholecystitis.

Detailed Description

The results of patients who underwent surgery for acute cholecystitis in a single center between January 2016 and December 2019 were included and evaluated retrospectively.

Primary outcome was subtotal cholecystectomy rate. Secondary outcomes were conversion to open, complications and serious complications. Within examining demographic findings, operative records (rates for subtotal cholecystectomy and conversion to open, operative duration) and follow-up results (postoperative complications, serious complications, length of hospital stay and mortality) for all cases were investigated. Complications that Clavien-Dindo Score ≥ 3 accepted as serious complication. Intraoperative detection of gallbladder perforation was also noted and included in comparison. Any biliary tract complication that needed any percutaneous or endoscopic intervention to handle was named as "biliary leak" in the study.

Study Timeline

• Study Start: 2022-12-10
• Primary Completion: 2023-01-10
• Study Completion: 2023-01-25
• Study First Submitted: 2023-02-05
• Study First Submitted QC: 2023-02-05
• Study First Posted: 2023-02-14
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-23
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 470

Inclusion Criteria

• Patients operated with the diagnosis of acute cholecystitis with an age greater or equal to 18 years old in a single center between January 2016 and December 2019

Exclusion Criteria

• Initial and direct preferance of open method
• Being diagnosed with malignity after histopathological evaluation
• Being operated just before one week after ERCP or after more than six weeks after ERCP

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ERCP group	ERCP	Patients who underwent surgery for acute cholecystitis with a previous ERCP history.

Primary Outcome Measures

Name	Time	Method
Subtotal Cholecystectomy Rate	Intraoperative	Rate of patients needed subtotal cholecystectomy after initial intent of starting laparoscopic to the cholecystectomy

Secondary Outcome Measures

Name	Time	Method
Conversion to open	Intraoperative	Rate of patients needed conversion to open after initial intent of starting laparoscopic to the cholecystectomy

Trial Locations

Locations (1)

Bakırkoy Dr.Sadi Konuk Training and Research Hospital; 🇹🇷 Istanbul, Turkey