NCT05474365

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

July 18, 2022

Last Update Submit

July 22, 2022

Conditions

Laparoscopic Suturing

Keywords

laparoscopic suturingstepwise trainingpractice schedulelaparoscopic skill acquisition

Outcome Measures

Primary Outcomes (1)

  • laparoscopic suturing competency assessment tool

    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

Study Arms (3)

Medical students

EXPERIMENTAL
Other: Stepwise training

Surgical trainees

EXPERIMENTAL
Other: Stepwise training

Attending Surgeons

NO INTERVENTION

Interventions

Stepwise trainingOTHER

The protocol of stepwise training is mentioned in Detailed description in Study Description.

Medical studentsSurgical trainees

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • th-graded medical students
  • Surgical trainees

You may not qualify if:

  • did not consent for the data collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shuang Ho Hospital

New Taipei City, Taiwan

Location

Related Publications (4)

  • McCluney AL, Vassiliou MC, Kaneva PA, Cao J, Stanbridge DD, Feldman LS, Fried GM. FLS simulator performance predicts intraoperative laparoscopic skill. Surg Endosc. 2007 Nov;21(11):1991-5. doi: 10.1007/s00464-007-9451-1.

    PMID: 17593434RESULT

  • Stefanidis D, Hope WW, Korndorffer JR Jr, Markley S, Scott DJ. Initial laparoscopic basic skills training shortens the learning curve of laparoscopic suturing and is cost-effective. J Am Coll Surg. 2010 Apr;210(4):436-40. doi: 10.1016/j.jamcollsurg.2009.12.015.

    PMID: 20347735RESULT

  • Thinggaard E, Bjerrum F, Strandbygaard J, Gogenur I, Konge L. Validity of a cross-specialty test in basic laparoscopic techniques (TABLT). Br J Surg. 2015 Aug;102(9):1106-13. doi: 10.1002/bjs.9857. Epub 2015 Jun 11.

    PMID: 26095788RESULT

  • IJgosse WM, Leijte E, Ganni S, Luursema JM, Francis NK, Jakimowicz JJ, Botden SMBI. Competency assessment tool for laparoscopic suturing: development and reliability evaluation. Surg Endosc. 2020 Jul;34(7):2947-2953. doi: 10.1007/s00464-019-07077-2. Epub 2019 Aug 26.

    PMID: 31451918RESULT

Study Officials

  • Chin-Hung Wei, MD

    Taipei Medical University Shuang Ho Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2022

First Posted

July 26, 2022

Study Start

September 1, 2020

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

July 26, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)