Laparoscopic SuturingNCT05474365
Stepwise Training Program
A study testing Stepwise training in people with Laparoscopic Suturing, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Suturing
- What is being tested?
- Stepwise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2020to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 5th-graded medical students
- Surgical trainees
Who cannot join
- did not consent for the data collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
- Application for Institution Review Board approval.
- 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.
- 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.
- 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)
- Conditions
- Laparoscopic Suturing
- Being tested
- Stepwise training
- Keywords
- laparoscopic suturing, stepwise training, practice schedule, laparoscopic skill acquisition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepwise trainingOther
The protocol of stepwise training is mentioned in Detailed description in Study Description.
| Study group | Role | What they receive |
|---|---|---|
| Medical students | Experimental | Not described Receives: Other: Stepwise training |
| Surgical trainees | Experimental | Not described Receives: Other: Stepwise training |
| Attending Surgeons | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Sep 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic SuturingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- IRCAD-Taiwan
- Responsible party
- Sponsor
- Investigators
- Chin-Hung Wei, MD, Study director, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474365
- Sponsor's protocol ID
- SHHstepwise01
- Status last verified
- Jul 2022
- First submitted
- 18 Jul 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17593434Stefanidis 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.
PubMed 20347735Thinggaard 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.
PubMed 26095788IJgosse 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.
PubMed 31451918
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepwise Training Program: a Novel Practice Model for Laparoscopic Suturing
- ClinicalTrials.gov ID
- NCT05474365
- Acronym / sponsor ID
- SHHstepwise01
- Conditions
- Laparoscopic Suturing
- Keywords
- laparoscopic suturing, stepwise training, practice schedule, laparoscopic skill acquisition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Collaborators
- IRCAD-Taiwan
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Application for Institution Review Board approval.
- 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.
- 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.
- 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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Medical students | Experimental | Other: Stepwise training |
| Surgical trainees | Experimental | Other: Stepwise training |
| Attending Surgeons | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 5th-graded medical students
- Surgical trainees
Key exclusion criteria (1 listed)
- did not consent for the data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stepwise trainingThe protocol of stepwise training is mentioned in Detailed description in Study Description. | Other | Medical students, Surgical trainees |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Results publication: PubMed 17593434McCluney 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.
- Results publication: PubMed 20347735Stefanidis 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.
- Results publication: PubMed 26095788Thinggaard 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.
- Results publication: PubMed 31451918IJgosse 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chin-Hung Wei, MD study director
Taipei Medical University Shuang Ho Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepwise training in people with Laparoscopic Suturing, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
laparoscopic suturing competency assessment tool (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05474365, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.