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Digital Educational Platform for Laparoscopy

N/A
Waitlist Available
Led By Boris Zevin
Research Sponsored by Queen's University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-6 weeks
Awards & highlights

Study Summary

This trial is designed to study the benefits of adding a digital educational platform module to a standard verbal consent for patients presenting with acute cholecystitis requiring an emergent laparoscopic cholecystectomy.

Eligible Conditions
  • Consent
  • Laparoscopy
  • Gallbladder Removal

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Knowledge of the Laparoscopic Cholecystectomy Procedure
Secondary outcome measures
Participant satisfaction with the clinical encounter
Retention of Knowledge
Self-reported rating of understanding of the laparoscopic cholecystectomy procedure.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Digital Educational PlatformExperimental Treatment1 Intervention
Study participants randomized to the DEP+SVC group (intervention) will be presented with an iPad with a link to an interactive DEP module discussing the indications for LC, alternatives, risks, complications, expectations and anticipated recovery. They will be asked to review the DEP module at their own pace and will be required to confirm understanding of all of the material presented on the DEP. Upon completion of the module, a member of the surgery team will ask the patient if they have any additional questions or require further clarification regarding the LC procedure, indications for surgery, alternatives, risk, complications, expectations and anticipated recovery. Once all of participant's questions are answered, an informed paper-based consent form for LC will be signed.
Group II: Standard Verbal ConsentActive Control1 Intervention
Study participants randomized to the SVC group (control) will discuss the LC procedure, indications for surgery, alternatives, risk, complications, expectations and anticipated recovery with a member of the surgery team. The study participant will be given the opportunity to ask questions and once all of the questions have been answered, an informed paper-based consent form for LC will be signed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Consent process with the addition of Digital educational platform (DEP)
2021
N/A
~80

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Who is running the clinical trial?

Queen's UniversityLead Sponsor
362 Previous Clinical Trials
119,412 Total Patients Enrolled
Boris ZevinPrincipal InvestigatorQueen's University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility criteria for enrolling in this clinical trial?

"This medical research requires participants to have had a cholecystectomy, be between 18 and 100 years of age, and is open for enrollment to 72 individuals."

Answered by AI

Is the age range for this experiment limited to persons above 70 years old?

"As outlined by the enrollment requirements of this experiment, applicants must have attained 18 years old and not exceeded 100 at the time of application."

Answered by AI

Is there currently a recruitment process for this investigation?

"According to clinicaltrials.gov, this trial is no longer accepting candidates. Initially posted on September 21st 2021 and last updated October 24th 2022, the study has now concluded recruitment efforts; though there are other studies that remain open for enrolment."

Answered by AI
~23 spots leftby Mar 2025