NCT05288257

Brief 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. The second qualitative phase will use depth interview to elaborate surgeon's experience regarding a safe laparoscopic cholecystectomy

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
217

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

12 months

First QC Date

February 8, 2022

Last Update Submit

October 24, 2022

Conditions

Learning ModuleCognitive Non-technical Skills

Keywords

Safe Laparoscopic CholecystectomySituation AwarenessDecision Making

Outcome Measures

Primary Outcomes (3)

  • Quantitative: Community Survey

    Survey data

    February - March 2022

  • Qualitative: In Depth Interview

    Semi-structured interview data obtained from In Depth Interview

    March - April 2022

  • Qualitative: Delphi Study

    Learning Module

    May 2022

Interventions

Learning ModuleBEHAVIORAL

Safe Cholecystectomy Learning Module

Also known as: Safe Cholecystectomy

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgeons and Surgical residents

You may qualify if:

  • Surgeons and / or surgical residents
  • Complete all the required documents

You may not qualify if:

  • Refuse to participate in one or more parts of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RSUP Fatmawati

Jakarta, DKI Jakarta, 11480, Indonesia

RECRUITING

Central Study Contacts

Adianto Nugroho, MD, FACS

CONTACT

0217660608kolesistektomi.aman@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 8, 2022

First Posted

March 21, 2022

Study Start

February 5, 2022

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

October 25, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)