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

NCT ID: NCT05728073

Last Updated: 2023-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

470 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-10

Study Completion Date

2023-01-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cholecystectomy, Laparoscopic Cholangiopancreatography, Endoscopic Retrograde

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard (non-ERCP) Group

Patients who underwent surgery for acute cholecystitis without a previous ERCP history.

No interventions assigned to this group

ERCP group

Patients who underwent surgery for acute cholecystitis with a previous ERCP history.

ERCP

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ERCP

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Turgut Donmez

Ass. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mehmet Karabulut

Role: STUDY_CHAIR

University of Health Sciences, Bakirkoy Dr.Sadi Konuk Training and Research Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bakırkoy Dr.Sadi Konuk Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20230205

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Laparoscopic Cholecystectomy After ERCP
NCT06197373 NOT_YET_RECRUITING