SAGES Safe Cholecystectomy Program in Polish Reality - Aw... | NCT03155321

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

NCT03155321

Sponsor

Jagiellonian University

Status

Terminated

Last Update Posted

Apr 7, 2022Actual

Enrollment

500Actual

Phase

Not provided

Conditions

Cholelithiasis
Cholecystectomy, Laparoscopic

Interventions

It's an observational study - no intervention is planned

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was complete

Expanded Access Info

Start Date

Apr 1, 2017Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

May 12, 2017

First Submission Date that Met QC Criteria

May 13, 2017

First Posted Date

May 16, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2022

Last Update Posted Date

Apr 7, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
It's an observational study - no intervention is planned	Other	No intervention is planned	Polish General Surgeons

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jagiellonian University Medical College		Krakow	Małopolska	31-008	Poland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32117489	Derived	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.

ID	Term
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases