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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03155321
Recruitment Status : Unknown
Verified May 2017 by Paweł Bogacki, Jagiellonian University.
Recruitment status was:  Recruiting
First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Paweł Bogacki, Jagiellonian University

Brief 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

Condition or disease Intervention/treatment
Cholelithiasis Cholecystectomy, Laparoscopic Other: It's an observational study - no intervention is planned

Detailed 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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

Group/Cohort Intervention/treatment
Polish General Surgeons
The group is formed by active polish general surgeons, both specialists and in training
Other: It's an observational study - no intervention is planned
No intervention is planned




Primary Outcome Measures :
  1. Mean usefulness score of each SAGES Safe Cholecystectomy Rule [ Time Frame: 01.04.2017 - 31.12.2017 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The population is formed by general surgeons in Poland that perform endoscopic cholecystectomy. It is both specialists and residents in training. No age limit was implemented.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155321


Contacts
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Contact: Paweł Bogacki, MD +48667177677 pawelbogacki1@gmail.com

Locations
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Poland
Jagiellonian University Medical College Recruiting
Kraków, Małopolska, Poland, 31-008
Contact: Mirosław Szura    +48609210030    miroslaw.szura@uj.edu.pl   
Sponsors and Collaborators
Jagiellonian University

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Responsible Party: Paweł Bogacki, MD, Jagiellonian University
ClinicalTrials.gov Identifier: NCT03155321     History of Changes
Other Study ID Numbers: K/ZDS/005504
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cholelithiasis
Cholecystolithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical