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

NCT05728073 | Completed

• 1 other identifier: 20230205
• Study Type: observational
• Target: 470
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystectomy, Laparoscopic; Cholangiopancreatography, Endoscopic Retrograde

Keywords

Acute Cholecystitis, Laparoscopic Subtotal Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Subtotal Cholecystectomy Rate

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

  Intraoperative

Secondary Outcomes (1)

• Conversion to open

  Intraoperative

Other Outcomes (5)

• Complications

  Postoperative first 90 days

• Serious complications

  Postoperative first 90 days

• Duration of operation

  Intraoperative

Study Arms (2)

Standard (non-ERCP) Group

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

ERCP group

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

Procedure: ERCP

Interventions

ERCP PROCEDURE

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

ERCP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

\- Patients operated with the diagnosis of acute cholecystitis a single center between January 2016 and December 2019.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakırkoy Dr.Sadi Konuk Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cholecystitis, Acute

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Mehmet Karabulut

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof. Dr.

Study Record Dates

• First Submitted: February 5, 2023
• First Posted: February 14, 2023
• Study Start: December 10, 2022
• Primary Completion: January 10, 2023
• Study Completion: January 25, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)