Clinical trial NCT03155321: SAGES Safe Cholecystectomy Program in Polish Reality - Awareness, Implementation and Opinion on Usefulness
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cholelithiasis
Cholecystectomy, Laparoscopic
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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

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.

Eligibility 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

Primary outcomes:
measure: Mean usefulness score of each SAGES Safe Cholecystectomy Rule
timeFrame: 01.04.2017 - 31.12.2017
Secondary outcomes:
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Jagiellonian University Medical College
state: Małopolska
Study officials:
References:
citation: Bogacki P, Krzak J, Gotfryd-Bugajska K, Szura M. Evaluation of the usefulness of the SAGES Safe Cholecystectomy Program from the viewpoint of the European surgeon. Wideochir Inne Tech Maloinwazyjne. 2020 Mar;15(1):80-86. doi: 10.5114/wiitm.2019.83297. Epub 2019 Mar 4.