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

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

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

Study Overview

• Status: Terminated
• Conditions: Cholecystectomy, Laparoscopic; Cholelithiasis
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Poland
  • Małopolska
    • Kraków, Małopolska, Poland, 31-008
      • Jagiellonian University Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jagiellonian University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: May 12, 2017
• First Submitted That Met QC Criteria: May 13, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: K/ZDS/005504

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