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Completed

NCT Number: NCT05728073

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.

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Key information

Conditions

Cholecystectomy, Laparoscopic Biliary Tract Diseases Cholangiopancreatography, Endoscopic Retrograde Cholecystitis Cholecystitis, Acute Digestive System Diseases Gallbladder Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bakırkoy Dr.Sadi Konuk Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERCP

Procedure

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

Primary outcomes

  1. Subtotal Cholecystectomy Rate

    Time frame: Intraoperative

    Rate of patients needed subtotal cholecystectomy after initial intent of starting laparoscopic to the cholecystectomy

Secondary outcomes

  1. Conversion to open

    Time frame: Intraoperative

    Rate of patients needed conversion to open after initial intent of starting laparoscopic to the cholecystectomy

Other outcomes

  1. Complications

    Time frame: Postoperative first 90 days

    Any complications experienced by patients who underwent emergency operation with the diagnosis of acute cholecystitis

  2. Serious complications

    Time frame: Postoperative first 90 days

    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)

  3. Duration of operation

    Time frame: Intraoperative

    Duration of emergency with the diagnosis of acute cholecystitis

  4. Length of hospital stay

    Time frame: Postoperative first 90 days

    Number of days patient stayed with and after the emergency operation with the diagnosis of acute cholecystitis

  5. Mortality

    Time frame: Postoperative first 90 days

    Number of patients that died after the emergency operation with the diagnosis of acute cholecystitis

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 14, 2023
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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