Articulated Laparoscopic Instruments Clinical Study

NCT05550974 | Unknown FDA Device

• 1 other identifier: 4-2022-0414
• Study Type: observational
• Target: 1,155
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancer

Keywords

Articulated laparoscopic instruments; gastrointestinal surgery; complication

Outcome Measures

Primary Outcomes (1)

• complication

  One of the most important surgical outcome, complication will be measured at 1 month after surgery

  1 month after surgery

Secondary Outcomes (12)

• Surgical outcome: operative time(min)

  1 month after surgery

• Surgical outcome: bleeding(ml)

  1 month after surgery

• Surgical outcome: pain score

  1 month after surgery

• Surgical outcome: hospital stay(day)

  1 month after surgery

• Surgical outcome: readmission rate(%)

  1 month after surgery

Study Arms (6)

LC

laparoscopic surgery using conventional laparoscopic instruments

Device: Minimally Invasive Surgery

LW

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

Device: Minimally Invasive Surgery

RC

Conventional robotic surgery

RSS

Use of singlesite system for reduced port robotic surgery

RSP

Use of da Vinci SP system for reduced port robotic surgery

RRI

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

Interventions

Minimally Invasive Surgery DEVICE

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

Also known as: Laparoscopic Surgery

LC; LW

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with gastric cancer scheduled to undergo gastrectomy in high volume center

You may qualify if:

• Patients with gastric cancer shcedulled for gastrectomy

You may not qualify if:

• Vulnerable subject (illiterate, pregnant)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Minimally Invasive Surgical Procedures; Laparoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Hyoung-Il Kim

  Yonsei University Health System, Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyoung-Il Kim

CONTACT

02-2228-2095; cairus@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 22, 2022
• Study Start: September 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)