Success of Intraoperative Cholangiography

August 7, 2019 updated by: Olli Helminen, Jyväskylä Central Hospital

Success of Routine Intraoperative Cholangiography

The purpose of the present study was to evaluate the success of routine use of intraoperative cholangiography (IOC ) and to examine the factors that are hindering the performance of intraoperative c-arm cholangiography.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

From January 2018 to August 2018 all consecutive elective and emergency cholecystectomies performed were entered in a prospective database. IOC has been instructed to be performed routinely when feasible during cholecystectomy since 1998. All elective operations were performed either by residents or specialist surgeons. For this study the investigators collected the radiation exposure values from exposure and pulsed fluoroscopy. Fluoroscopy time (s) was recorded.The operating surgeon was asked to fulfill a questionnaire directly after the cholecystectomy. The technical success and reasons for possible deferral of IOC were documented.Patient data from unsuccessful or deferred cholangiography cases was checked 6 months after cholecystectomy for possible symptomatic residual choledocholithiasis.Laparoscopic cholecystectomies were performed both by residents and specialist surgeons.

Ethics: The study was approved by the hospital administration.

Study Type

Observational

Enrollment (Actual)

201

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Jyväskylä, Finland, 40620
        • Central Finland Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all consecutive cholecystectomy patients during January 2018 to August 2018 which are operated with open or laparoscopic cholecystectomy for symptomatic cholelithiasis

Description

Inclusion Criteria:

  • all consecutive cholecystectomy patients during January 2018 to August 2018

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cholangiography success
From January 2018 to August 2018 all consecutive elective and emergency cholecystectomies performed with intraoperative success of cholangiography
Radiation: intraoperative cholangiography
success or failure of cholangiography
Cholangiography failure
From January 2018 to August 2018 all consecutive elective and emergency cholecystectomies performed with intraoperative failure of cholangiography
Radiation: intraoperative cholangiography
success or failure of cholangiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of intraoperative cholangiography
Time Frame: 6 months
number of successful cannulation
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
technical success of intraoperative cholangiography
Time Frame: 6 months
grades of technical success ( easy, , minimal difficulties, major difficulties)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jyväskylä Central Hospital

Investigators

  • Principal Investigator: Anne Mattila, M.D., Ph.D., Consultant Surgeon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

March 26, 2019

Study Completion (Actual)

March 26, 2019

Study Registration Dates

First Submitted

March 30, 2019

First Submitted That Met QC Criteria

August 7, 2019

First Posted (Actual)

August 12, 2019

Study Record Updates

Last Update Posted (Actual)

August 12, 2019

Last Update Submitted That Met QC Criteria

August 7, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOC1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cholecystolithiasis

Clinical Trials on intraoperative cholangiography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe