- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07311681
Stepwise Versus Conventional Training in Laparoscopic Suturing (stepwisetrain)
December 29, 2025 updated by: Taipei Medical University Shuang Ho Hospital
Break Down the Moves of Laparoscopic Suturing: Stepwise Training Program
This study will compare the learning outcomes between the participants undergoing stepwise training and conventional training for laparoscopic suturing.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
106
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Taiwan
-
New Taipei City, Taiwan, Taiwan, 235
- Shuang Ho Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- the 5th-years medical students in academic year 2020-2021 and 2022-2023
Exclusion Criteria:
- not consenting the research or not completing the training program or tests
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Stepwise
Participants undergoing stepwise training
|
Pick up needle: 10 mins (5 mins for each hand) Control needle angle: 20 mins (10 mins for each participant) Needle drive and pull thread: 20 mins (10 mins for each participant) Make double throws: 20 mins (10 mins for each participant) Knot tying: 20 mins (10 mins for each participant) Free practice: 30 mins (15 mins for each participant)
|
|
Other: Conventional
Participants undergoing conventional training
|
Repeating laparoscopic suturing all over
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
suturing time
Time Frame: From the first course to the 2nd post-course test in 2 months
|
the time to finish a standardized laparoscopic suturing knot
|
From the first course to the 2nd post-course test in 2 months
|
|
Laparoscopic suturing competency assessment tool
Time Frame: From the first course to the 2nd post-course test in 2 months
|
a validated assessment tool for laparoscopic suturing.
The lowest score is 8, which represents the best skill level.
The high the score is, the poorer the skill level is.
|
From the first course to the 2nd post-course test in 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 14, 2020
Primary Completion (Actual)
June 30, 2023
Study Completion (Actual)
July 31, 2024
Study Registration Dates
First Submitted
December 8, 2025
First Submitted That Met QC Criteria
December 29, 2025
First Posted (Actual)
December 31, 2025
Study Record Updates
Last Update Posted (Actual)
December 31, 2025
Last Update Submitted That Met QC Criteria
December 29, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- Stepwise vs. Conventional
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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