Knotting MethodsNCT05762575
Application of Spaghetti Knotting Technology in Single-hole Laparoscopic Suturing Instructional Program on the Basis of Multidirectional Stitching Technology.
An observational study of Knotting Methods and Single-port Laparoscopic Surgery, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
The surgeon's knot-tying technique plays a crucial role in the recovery of patients after single-port laparoscopy. Knot tying is very challenging in minimally invasive surgery and is a critical skill in advanced surgery. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Knotting Methods, Single-port Laparoscopic Surgery
- What is being tested?
- knotting methods
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2022to 26 Jan 2023
- Phase
- Observational
- 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
Study population: All the candidates were junior residents. Forty volunteers were selected according to the established criteria and randomly divided into control group and experimental group by computer-generated simple randomization. There were twenty volunteers in each group, and each group was composed of five males and fifteen females. The volunteers in control group study traditional knotting technology, and the volunteers in experimental group study new knotting technology. A statistician in our hospital completed the random distribution of the subjects and ensured the confidentiality of the grouping information. Before participating in the study, the subjects completed a questionnaire about their demographic information, such as age, gender and experience in video games.
Who may be able to join
- the habitual hand is the right hand;
- no practical experience in operating single-hole laparoscopic instruments;
- no simulator sickness;
- training and assessment are completed on time and carefully
Who cannot join
- have participated in other skills training programs
- are not interested in single-hole laparoscopy will be excluded
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Zhejiang
About this study
Official title: Application of New Knotting Methods in Single-hole Laparoscopic Suturing Instructional Program on the Basis of Multidirectional Stitching Technology
The surgeon's knot-tying technique plays a crucial role in the recovery of patients after single-port laparoscopy. Knot tying is very challenging in minimally invasive surgery and is a critical skill in advanced surgery. In this study, investigators introduce a new knotting technique, compare it with the traditional knotting technique in many aspects, and also discuss its application in the teaching of single-port laparoscopic knotting.
- Conditions
- Knotting Methods, Single-port Laparoscopic Surgery
- Being tested
- knotting methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
knotting methodsOther
The volunteers in experimental group study new knotting technology.
| Study group | Role | What they receive |
|---|---|---|
| control group | The volunteers in control group study traditional knotting technology, Receives: Other: knotting methods | |
| new knotting group | The volunteers in experimental group study new knotting technology. Receives: Other: knotting methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of needle entry
The needle stick should be in and out of the centre of the dot. The operator received 2 points if it was in the centre of the dot, 1 point if it deviated from the centre, and 0 points if it was outside the dot.
Measured: through study completion, an average of 1 month
Stability of the knot
The knot was required to be a surgical triple knot and should not have been a smooth knot or a loose knot. A normal knot received 2 points. A smooth knot received 1 point,and 0 points were awarded for a loose knot.
Measured: through study completion, an average of 1 month
Tissue integrity
The suture tissue should not be damaged or ruptured. The trainee received a score of two for integrity, 1 for a few cracks, and 0 for a complete fracture of the tissue.
Measured: through study completion, an average of 1 month
Tightness of the tissue
The tightness of the suture tissue indicated that the two sides of the sutured tissue were closely connected. The operator received 2 points if there was no gap between the two sides of the incision, 1 point for a few gaps, and 0 points for a totally loose suture.
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start25 Aug 2022
- Primary completion25 Jan 2023
- Study completion26 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knotting MethodsStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762575
- Sponsor's protocol ID
- SAHoWMU-CR2022-07-205
- Status last verified
- May 2023
- First submitted
- 23 Feb 2023
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of New Knotting Methods in Single-hole Laparoscopic Suturing Instructional Program on the Basis of Multidirectional Stitching Technology
- ClinicalTrials.gov ID
- NCT05762575
- Acronym / sponsor ID
- SAHoWMU-CR2022-07-205
- Conditions
- Knotting Methods, Single-port Laparoscopic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 26 Jan 2023 (actual)
- First posted
- 9 Mar 2023 (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.
The surgeon's knot-tying technique plays a crucial role in the recovery of patients after single-port laparoscopy. Knot tying is very challenging in minimally invasive surgery and is a critical skill in advanced surgery. In this study, investigators introduce a new knotting technique, compare it with the traditional knotting technique in many aspects, and also discuss its application in the teaching of single-port laparoscopic knotting.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | Other: knotting methodsThe volunteers in control group study traditional knotting technology, |
| new knotting group | – | Other: knotting methodsThe volunteers in experimental group study new knotting technology. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the candidates were junior residents. Forty volunteers were selected according to the established criteria and randomly divided into control group and experimental group by computer-generated simple randomization. There were twenty volunteers in each group, and each group was composed of five males and fifteen females. The volunteers in control group study traditional knotting technology, and the volunteers in experimental group study new knotting technology. A statistician in our hospital completed the random distribution of the subjects and ensured the confidentiality of the grouping information. Before participating in the study, the subjects completed a questionnaire about their demographic information, such as age, gender and experience in video games.
Key inclusion criteria (4 listed)
- the habitual hand is the right hand;
- no practical experience in operating single-hole laparoscopic instruments;
- no simulator sickness;
- training and assessment are completed on time and carefully
Key exclusion criteria (2 listed)
- have participated in other skills training programs
- are not interested in single-hole laparoscopy will be excluded
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 |
|---|---|---|
| knotting methodsThe volunteers in experimental group study new knotting technology. | Other | control group, new knotting group |
Primary outcome
Accuracy of needle entry
Time frame: through study completion, an average of 1 month
The needle stick should be in and out of the centre of the dot. The operator received 2 points if it was in the centre of the dot, 1 point if it deviated from the centre, and 0 points if it was outside the dot.
Stability of the knot
Time frame: through study completion, an average of 1 month
The knot was required to be a surgical triple knot and should not have been a smooth knot or a loose knot. A normal knot received 2 points. A smooth knot received 1 point,and 0 points were awarded for a loose knot.
Tissue integrity
Time frame: through study completion, an average of 1 month
The suture tissue should not be damaged or ruptured. The trainee received a score of two for integrity, 1 for a few cracks, and 0 for a complete fracture of the tissue.
Tightness of the tissue
Time frame: through study completion, an average of 1 month
The tightness of the suture tissue indicated that the two sides of the sutured tissue were closely connected. The operator received 2 points if there was no gap between the two sides of the incision, 1 point for a few gaps, and 0 points for a totally loose suture.
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 6 May 2023.
Related trials for Knotting Methods
Not yet recruiting
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Chronic Neck Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knotting Methods and Single-port Laparoscopic Surgery, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
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 4 inclusion and 2 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 6 May 2023. 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 China. 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?
Accuracy of needle entry (time frame: through study completion, an average of 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2023.