Application of Spaghetti Knotting Technology in Single-hole Laparoscopic Suturing Instructional Program on the Basis of Multidirectional Stitching Technology.

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.

Study Overview

• Status: Completed
• Conditions: Knotting Methods; Single-port Laparoscopic Surgery
• Intervention / Treatment: Other: knotting methods

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• China
  • Zhejiang, China
    • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

1. the habitual hand is the right hand;
2. no practical experience in operating single-hole laparoscopic instruments;
3. no simulator sickness;
4. training and assessment are completed on time and carefully

Exclusion Criteria:

1. have participated in other skills training programs
2. are not interested in single-hole laparoscopy will be excluded

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control group; The volunteers in control group study traditional knotting technology,	Other: knotting methods; The volunteers in experimental group study new knotting technology.
new knotting group; The volunteers in experimental group study new knotting technology.	Other: knotting methods; The volunteers in experimental group study new knotting technology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	through study completion, an average of 1 month

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2022
• Primary Completion (Actual): January 25, 2023
• Study Completion (Actual): January 26, 2023

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 9, 2023

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SAHoWMU-CR2022-07-205

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No