Learning ModuleNCT05288257
Mixed Method Study Protocol_Cognitive Non-technical Skills Learning Module for a Safe Laparoscopic Cholecystectomy
An observational study of Learning Module and Cognitive Non-technical Skills, run by RSUP Fatmawati at 1 site in Indonesia.
Trial summary
A mixed-methods sequential explanatory design study. The first quantitative phase will be an online survey to surgeons that includes questions related to their experience learning and performing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Learning Module, Cognitive Non-technical Skills
- What is being tested?
- Learning Module
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 217 participants
- Where
- 1 siteIndonesia
- Study dates
- 5 Feb 2022to 31 Jan 2023
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Surgeons and Surgical residents
Who may be able to join
- Surgeons and / or surgical residents
- Complete all the required documents
Who cannot join
- Refuse to participate in one or more parts of the study
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
RSUP Fatmawati
Jakarta, DKI Jakarta, 11480
Adianto Nugroho, MD, FACS, 0217660608, kolesistektomi.aman@gmail.com
About this study
Official title: The Role Cognitive Non-technical Skills Learning Module in Promoting A Safe Laparoscopic Cholecystectomy: Critical Analysis on Situation Awareness and Intraoperative Decision Making in the Prevention of Complications
A mixed-methods sequential explanatory design study. The first quantitative phase will be an online survey to surgeons that includes questions related to their experience learning and performing laparoscopic cholecystectomy. The second qualitative phase will use depth interview to elaborate surgeon's experience regarding a safe laparoscopic cholecystectomy
Read the detailed description
Bile duct injuries from laparoscopic cholecystectomy remain a significant source of morbidity and are often the result of intraoperative errors in perception, judgment, and decision-making. Cognitive non-technical skills namely situation awareness and decision-making skills are essential in doing a safe laparoscopic cholecystectomy, as in any kind of surgery. Studies regarding cognitive non-technical skills and how to teach them are still lacking, especially in the field of surgery.
With this study, the investigators aim to formulate a comprehensive learning module for a safe laparoscopic cholecystectomy accomodating cognitive non-technical skills based on the surgeon's experience while learning and doing laparoscopic cholecystectomy.
- Conditions
- Learning Module, Cognitive Non-technical Skills
- Being tested
- Learning Module
- Keywords
- Safe Laparoscopic Cholecystectomy, Situation Awareness, Decision Making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning ModuleBehavioural
Also called Safe Cholecystectomy
Safe Cholecystectomy Learning Module
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative: Community Survey
Survey data
Measured: February - March 2022
Qualitative: In Depth Interview
Semi-structured interview data obtained from In Depth Interview
Measured: March - April 2022
Qualitative: Delphi Study
Learning Module
Measured: May 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start5 Feb 2022
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Learning ModuleStudies 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
- Prospective
- Enrolment
- 217 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RSUP Fatmawati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adianto Nugroho, RSUP Fatmawati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288257
- Sponsor's protocol ID
- 22-01-0029
- Status last verified
- Oct 2022
- First submitted
- 8 Feb 2022
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role Cognitive Non-technical Skills Learning Module in Promoting A Safe Laparoscopic Cholecystectomy: Critical Analysis on Situation Awareness and Intraoperative Decision Making in the Prevention of Complications
- ClinicalTrials.gov ID
- NCT05288257
- Acronym / sponsor ID
- 22-01-0029
- Conditions
- Learning Module, Cognitive Non-technical Skills
- Keywords
- Safe Laparoscopic Cholecystectomy, Situation Awareness, Decision Making
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 217 participants (estimated)
- Lead sponsor
- RSUP FatmawatiUniversity, hospital or other
- Study start
- 5 Feb 2022 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 21 Mar 2022 (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.
A mixed-methods sequential explanatory design study. The first quantitative phase will be an online survey to surgeons that includes questions related to their experience learning and performing laparoscopic cholecystectomy. The second qualitative phase will use depth interview to elaborate surgeon's experience regarding a safe laparoscopic cholecystectomy
Detailed description
Bile duct injuries from laparoscopic cholecystectomy remain a significant source of morbidity and are often the result of intraoperative errors in perception, judgment, and decision-making. Cognitive non-technical skills namely situation awareness and decision-making skills are essential in doing a safe laparoscopic cholecystectomy, as in any kind of surgery. Studies regarding cognitive non-technical skills and how to teach them are still lacking, especially in the field of surgery.
With this study, the investigators aim to formulate a comprehensive learning module for a safe laparoscopic cholecystectomy accomodating cognitive non-technical skills based on the surgeon's experience while learning and doing laparoscopic cholecystectomy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Surgeons and Surgical residents
Key inclusion criteria (2 listed)
- Surgeons and / or surgical residents
- Complete all the required documents
Key exclusion criteria (1 listed)
- Refuse to participate in one or more parts of the study
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 |
|---|---|---|
| Learning ModuleAlso: Safe CholecystectomySafe Cholecystectomy Learning Module | Behavioural | – |
Primary outcome
Quantitative: Community Survey
Time frame: February - March 2022
Survey data
Qualitative: In Depth Interview
Time frame: March - April 2022
Semi-structured interview data obtained from In Depth Interview
Qualitative: Delphi Study
Time frame: May 2022
Learning Module
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- 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.
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 Learning Module and Cognitive Non-technical Skills, run by RSUP Fatmawati at 1 site in Indonesia.
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 1 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: status not confirmed, as of the sponsor's last update on 25 Oct 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 Indonesia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adianto Nugroho, MD, FACS (0217660608, kolesistektomi.aman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative: Community Survey (time frame: February - March 2022). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2022.