Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05728073
Other study ID # 20230205
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 10, 2022
Est. completion date January 25, 2023

Study information

Verified date September 2023
Source Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 470
Est. completion date January 25, 2023
Est. primary completion date January 10, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Bakirkoy Dr.Sadi Konuk Training and Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Complications Any complications experienced by patients who underwent emergency operation with the diagnosis of acute cholecystitis Postoperative first 90 days
Other Serious complications 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) Postoperative first 90 days
Other Duration of operation Duration of emergency with the diagnosis of acute cholecystitis Intraoperative
Other Length of hospital stay Number of days patient stayed with and after the emergency operation with the diagnosis of acute cholecystitis Postoperative first 90 days
Other Mortality Number of patients that died after the emergency operation with the diagnosis of acute cholecystitis Postoperative first 90 days
Primary Subtotal Cholecystectomy Rate Rate of patients needed subtotal cholecystectomy after initial intent of starting laparoscopic to the cholecystectomy Intraoperative
Secondary Conversion to open Rate of patients needed conversion to open after initial intent of starting laparoscopic to the cholecystectomy Intraoperative
See also
  Status Clinical Trial Phase
Recruiting NCT05035433 - Effect of the Sequence of Dilatation and Lithotripsy on the Treatment of Choledocholithiasis With ERCP N/A
Completed NCT02985164 - Radiation Exposure During Endoscopic Retrograde Cholangiopancreatography Phase 3
Completed NCT05533944 - Fast-tracking ERCP Learning: Does Training on a Mechanical Simulator Improve Trainee's Clinical Performance? N/A
Suspended NCT04559867 - Fistulotomy as the Primary Cannulation Technique for All Patients Undergoing ERCP: A Randomized, Controlled Trial N/A
Active, not recruiting NCT05592795 - Explore the Effects and Mechanisms of ERCP and EST on Biliary Microecology
Enrolling by invitation NCT04719117 - Retrograde Cholangiopancreatography AI Assisted System Validation on Effectiveness and Safety
Enrolling by invitation NCT04572711 - Prospective Evaluation of Biliary Tissue Sampling With ERCP
Completed NCT03263481 - Intraductal Secretin Stimulation Test: What Is the Proper Collection Time? N/A
Completed NCT03292627 - Non-invasive Monitor in Endoscopic Invasive Procedure
Recruiting NCT06265311 - IDUS in CBD Stone Recurrence High Risk Patients N/A
Completed NCT06031363 - The Optimal Dose of Indomethacin Suppository for Preventing Post-ERCP Pancreatitis N/A
Recruiting NCT05261997 - Endotherapy for Painless Chronic Pancreatitis N/A
Completed NCT02698137 - Quality Assessment in Endoscopic Retrograde Cholangiopancreatography(ERCP)
Recruiting NCT05246657 - EUS-guided Entero-biliary Anastomosis for Therapeutic Access in Benign Biliary Obstructions
Recruiting NCT04910087 - The Effect of Anesthesia Management on Optic Nerve Sheath Diameter in the Ercp Procedures N/A
Recruiting NCT05303662 - Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an ERCP in Four Different Countries
Terminated NCT05129449 - A Clinical Study With the Medical Device PowerSpiral for Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
Completed NCT03561441 - Tailored Hydration for the Prevention of Post-ERCP Pancreatitis N/A
Not yet recruiting NCT06196164 - A RCT of Low MBO Drainage Strategies N/A
Terminated NCT01792466 - RCT of the Double Wire Technique for Sphincterotomy N/A