CholelithiasisNCT03155321
SAGES Safe Cholecystectomy Program in Polish Reality - Awareness, Implementation and Opinion on Usefulness
An observational study of Cholelithiasis and Cholecystectomy, Laparoscopic, run by Jagiellonian University at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cholelithiasis, Cholecystectomy, Laparoscopic
- How many people
- 500 participants
- Where
- 1 sitePoland
- Study dates
- 1 Apr 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older 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.
Who may be able to join
- general surgery specialist or resident registered in Polish National Doctors' Registry
- filled questionnaire on SAGES Safe Cholecystectomy Program
Who cannot join
- questionnaire not filled properly, missing answers
- declaration of not being either general surgeon specialist of general surgery resident in Poland
Trial locations and contacts
1 site in 1 country.
Poland1 site
Jagiellonian University Medical College
Krakow, Małopolska, 31-008
About this study
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
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
Read the 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.
- Conditions
- Cholelithiasis, Cholecystectomy, Laparoscopic
- Being tested
- It's an observational study - no intervention is planned
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
It's an observational study - no intervention is plannedOther
No intervention is planned
| Study group | Role | What they receive |
|---|---|---|
| Polish General Surgeons | The group is formed by active polish general surgeons, both specialists and in training Receives: Other: It's an observational study - no intervention is planned |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 01.04.2017 - 31.12.2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start1 Apr 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Why it stopped: Study was complete
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paweł Bogacki, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155321
- Sponsor's protocol ID
- K/ZDS/005504
- Status last verified
- Mar 2022
- First submitted
- 12 May 2017
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32117489
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03155321
- Acronym / sponsor ID
- K/ZDS/005504
- Conditions
- Cholelithiasis, Cholecystectomy, Laparoscopic
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was complete
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polish General Surgeons | – | Other: It's an observational study - no intervention is plannedThe group is formed by active polish general surgeons, both specialists and in training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (2 listed)
- general surgery specialist or resident registered in Polish National Doctors' Registry
- filled questionnaire on SAGES Safe Cholecystectomy Program
Key exclusion criteria (2 listed)
- questionnaire not filled properly, missing answers
- declaration of not being either general surgeon specialist of general surgery resident in Poland
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| It's an observational study - no intervention is plannedNo intervention is planned | Other | Polish General Surgeons |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Study was complete). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Derived from this study: PubMed 32117489Bogacki 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholelithiasis and Cholecystectomy, Laparoscopic, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was complete). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean usefulness score of each SAGES Safe Cholecystectomy Rule (time frame: 01.04.2017 - 31.12.2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03155321, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.