Articulated Laparoscopic Instruments Clinical Study

NCT ID: NCT05550974

Last Updated: 2022-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-30

Study Completion Date

2024-12-31

Brief Summary

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Recently, with the development of minimally invasive surgery and the development of instruments, laparoscopic and robotic surgery are increasing, and laparoscopic and robotic surgery are evolving. The association between the new surgical instruments used in each upper gastrointestinal surgery and the results has been traditionally analyzed through the learning curve, and in addition, the study aims to collect and analyze the utilization of the instrument and surgical results prospectively through surgical video analysis.

Detailed Description

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Prior to surgery, all patients subject to the study are explained and informed of the prior consent form of prior consent is delivered. During surgery, video recording is performed to check the type of surgical instrument, the time of use, and the event that occurred during surgery. After surgery, the morbidity after surgery will be monitored and recorded. Additional morbidity will be recorded one to three months after surgery.

Conditions

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Gastric Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LC

laparoscopic surgery using conventional laparoscopic instruments

Minimally Invasive Surgery

Intervention Type DEVICE

gynecological, urologic, thoracic, plastic and reconstructive and ENT etc. endoscopic and laparoscopic surgical procedures

LW

Using wristed laparoscopic instruments (Artisential Maryland dissector, Artisential Fenestrated gasper)

Minimally Invasive Surgery

Intervention Type DEVICE

gynecological, urologic, thoracic, plastic and reconstructive and ENT etc. endoscopic and laparoscopic surgical procedures

RC

Conventional robotic surgery

No interventions assigned to this group

RSS

Use of singlesite system for reduced port robotic surgery

No interventions assigned to this group

RSP

Use of da Vinci SP system for reduced port robotic surgery

No interventions assigned to this group

RRI

A new surgical robot Revo-i developed by Meerae company in Korea

No interventions assigned to this group

Interventions

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Minimally Invasive Surgery

gynecological, urologic, thoracic, plastic and reconstructive and ENT etc. endoscopic and laparoscopic surgical procedures

Intervention Type DEVICE

Other Intervention Names

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Laparoscopic Surgery

Eligibility Criteria

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Inclusion Criteria

Patients with gastric cancer shcedulled for gastrectomy

Exclusion Criteria

Vulnerable subject (illiterate, pregnant)
Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hyoung-Il Kim

Role: PRINCIPAL_INVESTIGATOR

Yonsei University Health System, Severance Hospital

Locations

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Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyoung-Il Kim

Role: CONTACT

02-2228-2095

Facility Contacts

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Hyoung-Il Kim

Role: primary

02-2228-2095

Other Identifiers

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4-2022-0414

Identifier Type: -

Identifier Source: org_study_id

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