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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05728073
Enrollment
470
Registered
2023-02-14
Start date
2022-12-10
Completion date
2023-01-25
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangiopancreatography, Endoscopic Retrograde, Cholecystectomy, Laparoscopic

Keywords

Acute Cholecystitis, Laparoscopic Subtotal Cholecystectomy

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.

Interventions

PROCEDUREERCP

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

Sponsors

Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Subtotal Cholecystectomy RateIntraoperativeRate of patients needed subtotal cholecystectomy after initial intent of starting laparoscopic to the cholecystectomy

Secondary

MeasureTime frameDescription
Conversion to openIntraoperativeRate of patients needed conversion to open after initial intent of starting laparoscopic to the cholecystectomy

Other

MeasureTime frameDescription
Duration of operationIntraoperativeDuration of emergency with the diagnosis of acute cholecystitis
ComplicationsPostoperative first 90 daysAny complications experienced by patients who underwent emergency operation with the diagnosis of acute cholecystitis
MortalityPostoperative first 90 daysNumber of patients that died after the emergency operation with the diagnosis of acute cholecystitis
Length of hospital stayPostoperative first 90 daysNumber of days patient stayed with and after the emergency operation with the diagnosis of acute cholecystitis
Serious complicationsPostoperative first 90 daysAny 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)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026