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

Cholangiopancreatography, Endoscopic Retrograde Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05728073
• Other study ID #: 20230205
• Status: Completed
• Start date: December 10, 2022
• Est. completion date: January 25, 2023

Study information

• Verified date: September 2023
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: January 25, 2023
• Est. primary completion date: January 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangiopancreatography, Endoscopic Retrograde
• Cholecystectomy, Laparoscopic
• Cholecystitis
• Cholecystitis, Acute

Intervention

Procedure:
• ERCP
Patients separated to two groups according to having a ERCP history before the operation

Locations

Country	Name	City	State
Turkey	Bakirkoy Dr.Sadi Konuk Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications	Any complications experienced by patients who underwent emergency operation with the diagnosis of acute cholecystitis	Postoperative first 90 days
Other	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
Other	Duration of operation	Duration of emergency with the diagnosis of acute cholecystitis	Intraoperative
Other	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
Other	Mortality	Number of patients that died after the emergency operation with the diagnosis of acute cholecystitis	Postoperative first 90 days
Primary	Subtotal Cholecystectomy Rate	Rate of patients needed subtotal cholecystectomy after initial intent of starting laparoscopic to the cholecystectomy	Intraoperative
Secondary	Conversion to open	Rate of patients needed conversion to open after initial intent of starting laparoscopic to the cholecystectomy	Intraoperative