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

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.

Study Overview

• Status: Completed
• Conditions: Cholecystectomy, Laparoscopic; Cholangiopancreatography, Endoscopic Retrograde
• Intervention / Treatment: Procedure: ERCP

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 Type: Observational
• Enrollment (Actual): 470

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Bakırkoy Dr.Sadi Konuk Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

- Patients operated with the diagnosis of acute cholecystitis a single center between January 2016 and December 2019.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard (non-ERCP) Group; Patients who underwent surgery for acute cholecystitis without a previous ERCP history.	Procedure: ERCP; Patients separated to two groups according to having a ERCP history before the operation
ERCP group; Patients who underwent surgery for acute cholecystitis with a previous ERCP history.	Procedure: ERCP; Patients separated to two groups according to having a ERCP history before the operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subtotal Cholecystectomy Rate	Rate of patients needed subtotal cholecystectomy after initial intent of starting laparoscopic to the cholecystectomy	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conversion to open	Rate of patients needed conversion to open after initial intent of starting laparoscopic to the cholecystectomy	Intraoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Any complications experienced by patients who underwent emergency operation with the diagnosis of acute cholecystitis	Postoperative first 90 days
Duration of operation	Duration of emergency with the diagnosis of acute cholecystitis	Intraoperative
Length of hospital stay	Number of days patient stayed with and after the emergency operation with the diagnosis of acute cholecystitis	Postoperative first 90 days
Mortality	Number of patients that died after the emergency operation with the diagnosis of acute cholecystitis	Postoperative first 90 days
Serious complications	Any complications that has a Clavien-Dindo Score ≥ 3 experienced by patients who underwent emergency operation with the diagnosis of acute cholecystitis. (Clavien Dindo Score System that classifying post-operative complications in 5 main levels. Higher the score, the more significant complications. While level 1 is the lightest, level 5 means death)	Postoperative first 90 days

Collaborators and Investigators

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Investigators: Study Chair: Mehmet Karabulut, University of Health Sciences, Bakirkoy Dr.Sadi Konuk Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2022
• Primary Completion (Actual): January 10, 2023
• Study Completion (Actual): January 25, 2023

Study Registration Dates

• First Submitted: February 5, 2023
• First Submitted That Met QC Criteria: February 5, 2023
• First Posted (Actual): February 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 23, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Acute Cholecystitis, Laparoscopic Subtotal Cholecystectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
• Other Study ID Numbers: 20230205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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