Stepwise Training Program

July 22, 2022 updated by: Taipei Medical University Shuang Ho Hospital

Stepwise Training Program: a Novel Practice Model for Laparoscopic Suturing

Laparoscopic skills training is essential and has been correlated with intraoperative performance. There are a number of training curricula developed to shorten the laparoscopic learning curve. Laparoscopic suturing is an advanced technique of laparoscopic skills that requires high level of hand-eye coordination.

After obtaining basic laparoscopic skills, the trainees traditionally progress to learn intracorporeal suturing by serially repeating the multiple steps required to complete laparoscopic suture. It has been advocated that teaching of complex laparoscopic task should be divided into necessary steps. Therefore, the steps of intracorporeal suturing can be broken down into discrete blocks, such as needle pick up, passing needle, and forming a knot. The learner is to repetitively practice one step in one block to master the required skill before moving on to the next block. This form of blocked practice has been recognized effective and efficient for motor skill acquisition.

We established stepwise training program for laparoscopic intracorporeal suturing based on the concept of blocked practice for the medical students and surgical trainees in our institution. It is our hypothesis that the stepwise program will improve laparoscopic suturing techniques of the participants. The purpose of this study is to assess the learning outcomes of laparoscopic suturing learning outcomes after our novel stepwise training program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Application for Institution Review Board approval.

  2. Voluntary participants were recruited from 5th-graded medical students, surgical trainees, and attending surgeons in single institution. An informed consent was obtained from the participants. The training courses and tests for medical students, surgical trainees and attending surgeons were described as follows:

    The medical students watched a pre-course video of laparoscopic suturing, followed by two 2-hour courses of stepwise training for laparoscopic suturing. A test of the standard laparoscopic suturing task was performed immediately after each course.

    The surgical trainees took single 2-hour course of stepwise training without watching the pre-course video. A test of the standard laparoscopic suturing task was performed before and after the course.

    Attending surgeons were invited to take the test as controls without joining the course.

  3. Equipment and laparoscopic task The training and task were performed on iSuture laparoscopic training desk. A 3-0 polysorbTM (Covidien, GL-182) with a 20-cm length of thread was used for the laparoscopic task. The participants were required to fulfill an intracorporeal suture with a first double-throw knot, followed by two single-throw knots on the suture pad.
  4. Stepwise training program

The instructor described the schedule to the participants in the beginning of the program. Two participants shared a set of the equipment and practiced in turn in blocks. At the beginning of each block, the step was demonstrated with video clips. The participants only practiced the specified step in the block before proceeding to the next block. The detailed schedule is listed as follows:

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)

Study Type

Interventional

Enrollment (Actual)

24

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
        • 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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 5th-graded medical students
  • Surgical trainees

Exclusion Criteria:

  • did not consent for the data collection

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Medical students
Other: Stepwise training
The protocol of stepwise training is mentioned in Detailed description in Study Description.
EXPERIMENTAL: Surgical trainees
Other: Stepwise training
The protocol of stepwise training is mentioned in Detailed description in Study Description.
NO_INTERVENTION: Attending Surgeons

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
laparoscopic suturing competency assessment tool
Time Frame: 6 months
All the tests were video recorded. The videos were processed with de-identification and random coding, and then reviewed independently by two expert surgeons (HC & CW) who were blinded to the identity of the test-taker. A previously validated tool, laparoscopic suturing competency assessment tool (LS-CAT), was used to evaluate the videos. LS-CAT is composed of four domains, "pick up needle", "pass needle through edges", "create first double wind", and "knot tying". A low score in LS-CAT represented a high level of skill set with a score of 8 indicating the best performance. Suturing time was measured.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University Shuang Ho Hospital

Collaborators

IRCAD-Taiwan

Investigators

  • Study Director: Chin-Hung Wei, MD, Taipei Medical University Shuang Ho Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2020

Primary Completion (ACTUAL)

March 31, 2021

Study Completion (ACTUAL)

March 31, 2021

Study Registration Dates

First Submitted

July 18, 2022

First Submitted That Met QC Criteria

July 22, 2022

First Posted (ACTUAL)

July 26, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SHHstepwise01

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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