Study on a novel laparoscopic trocar with built-in fascial closure function (CLOCAR)

Not Applicable

Completed

• Conditions: Neoplasms

• Registration Number: KCT0003389
• Lead Sponsor: The Catholic University of Korea, St. Vincent's Hospital

Brief Summary

The first result is to complete the closure of the port site using EZ or CT It was the time it took to The procedure starts when the device starts the port site defined as the first time it was inserted, and the end of the procedure is that the port site Defined as point of time removed from the port site. a stopwatch poem Used to measure liver. Secondary results indicate whether visceral organs were damaged and additional information was added during surgery It was investigated whether the instrument was necessary. Also, wound infection, ten wounds, and mask intestines, multiple fluid leaks 3 days after surgery and 1 week after discharge. Of the 93 patients evaluated for eligibility, 14 were excluded C(8) did not meet the inclusion criteria and 6 refused to participate in the study .) A total of 79 patients were randomly assigned: 40 were EZ Rup, 39 people have been assigned to the CT group. One patient in the EZ group is a patient Follow-up failed because was transferred to the oncology department. Choi In the species analysis, a total of 78 patients (39 patients per group) were analyzed (Fig. 3).

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-07-31
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1) Patients who used laparoscopic ports over 10mm during laparoscopic or robotic surgery
2) aged over 18, under 80
3) Patients who voluntarily agreed in writing to participate in the trial

Exclusion Criteria

1) Patients who underwent simultaneous operations other than laparoscopic/robotic surgery
2) Patients with severe head injury or stroke or a history of the disease
3) Patients living in a nursing home or accommodation with poor cognitive ability
4) Patients with acute or chronic medical or psychiatric conditions or laboratory abnormalities that are not appropriate for participation in the clinical study
5) Patients who are judged to be unappropriate for the clinical study

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time for port-site closure

Secondary Outcome Measures

Name	Time	Method
Port-site hernia;Port-site infection;Port-site ascitic leak;Injury to adjacent organs;Gas leak;Need for additional instrument;Durability