Completed

NCT Number: NCT05762575

Application of Spaghetti Knotting Technology 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.

Completed

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Key information

Conditions

Knotting Methods Single-port Laparoscopic Surgery

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Zhejiang, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

knotting methods

Other

The volunteers in experimental group study new knotting technology.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Mar 9, 2023
Registry last updated: May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.