Clinical trial NCT05728073: Does Subtotal Cholecystectomy Rate for Acute Cholecystitis Change With a Previous ERCP?
Official title: Does Subtotal Cholecystectomy Rate for Acute Cholecystitis Change With a Previous ERCP?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholecystectomy, Laparoscopic
Cholangiopancreatography, Endoscopic Retrograde
Keywords: Acute Cholecystitis, Laparoscopic Subtotal Cholecystectomy
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2023-02-14
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - Patients operated with the diagnosis of acute cholecystitis a single center between January 2016 and December 2019.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Subtotal Cholecystectomy Rate
timeFrame: Intraoperative
Secondary outcomes:
measure: Conversion to open
timeFrame: Intraoperative
Other outcomes:
measure: Complications
timeFrame: Postoperative first 90 days
measure: Serious complications
timeFrame: Postoperative first 90 days
measure: Duration of operation
timeFrame: Intraoperative
measure: Length of hospital stay
timeFrame: Postoperative first 90 days
measure: Mortality
timeFrame: Postoperative first 90 days
Locations:
city: Istanbul
country: Turkey
facility: Bakırkoy Dr.Sadi Konuk Training and Research Hospital
Study officials:
affiliation: University of Health Sciences, Bakirkoy Dr.Sadi Konuk Training and Research Hospital
name: Mehmet Karabulut
role: STUDY_CHAIR
References: