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NCT03155321 Clinical Trial

SAGES Safe Cholecystectomy Program in Polish Reality - Awareness, Implementation and Opinion on Usefulness

Cholelithiasis Clinical Trial

Official title:
The Assessment of Awareness and Implementation of the SAGES Safe Cholecystectomy Program Among Polish Surgeons, as Well as Their Opinion on the Usefulness of the SAGES Safe Cholecystectomy Rules: Increasing the Safety of Cholecystectomy by Popularising the SAGES Safe Cholecystectomy Program

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03155321
Other study ID # K/ZDS/005504
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date April 1, 2017
Est. completion date December 31, 2018

Study information
Verified date March 2022
Source Jagiellonian University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study is designed to assess the awareness of the SAGES Safe Cholecystectomy Program among polish surgeons, as well as the degree of implementation of this Program during laparoscopic cholecystectomy performed in Poland. It also gathers the opinion of polish surgeons on usefulness of each of the SAGES Safe Cholecystectomy Rules

Description:

The study is based on an anonymous questionnaire that is distributed among polish surgeons across the country. The questionnaire focuses on the demographic data of the surgeon, their experience in years, a few questions regarding their experience in the field of cholecystectomy surgery and questions about whether or not they are familiar with the SAGES Safe Cholecystectomy Program, Teaching Program for the Culture of Safety in Cholecystectomy, as well as Updated Tokyo Guidelines for the management of acute cholangitis and cholecystitis. The questionnaire is available as an appendix. It is then followed by the list of all the Rules of SAGES Safe Cholecystectomy Program with questions about the usefulness of each of the rule, evaluated in form of a 10-point numeric scale (0 - completely useless, 9 - critical). The collected data will be subject to statistical analysis, the result of which will form the base for creating the Polish Program for Safe Cholecystectomy that will serve to increase the safety of this very common surgical procedure.

Recruitment information / eligibility
Status Terminated
Enrollment 500
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - general surgery specialist or resident registered in Polish National Doctors' Registry - filled questionnaire on SAGES Safe Cholecystectomy Program Exclusion Criteria: - questionnaire not filled properly, missing answers - declaration of not being either general surgeon specialist of general surgery resident in Poland

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• It's an observational study - no intervention is planned
No intervention is planned

Locations
Country Name City State
Poland Jagiellonian University Medical College Kraków Malopolska

Sponsors (1)
Lead Sponsor Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean usefulness score of each SAGES Safe Cholecystectomy Rule The usefulness of each rule will be assessed by the participants on a 10-point numeric scale (0 - useless, 9 - critical) which will be part of the questionnaire 01.04.2017 - 31.12.2017
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