Articulated Laparoscopic Instruments Clinical Study

Gastric Cancer Clinical Trial

Official title:

Articulating Laparoscopic Instrument Assisted Minimally Invasive Upper GastroIntestinal Surgery: AMUGIS Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05550974
• Other study ID #: 4-2022-0414
• Status: Recruiting
• Start date: September 2022
• Est. completion date: December 2024

Study information

• Verified date: September 2022
• Source: Yonsei University
• Contact: Hyoung-Il Kim
• Phone: 02-2228-2095
• Email: cairus[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1155
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

Inclusion Criteria:

Patients with gastric cancer shcedulled for gastrectomy

Exclusion Criteria:

Vulnerable subject (illiterate, pregnant)

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Device:
• Minimally Invasive Surgery
gynecological, urologic, thoracic, plastic and reconstructive and ENT etc. endoscopic and laparoscopic surgical procedures

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complication	One of the most important surgical outcome, complication will be measured at 1 month after surgery	1 month after surgery
Secondary	Surgical outcome: operative time(min)		1 month after surgery
Secondary	Surgical outcome: bleeding(ml)	operative time(min), bleeding(ml), pain score, hospital stay(day), readmission rate(%), serum CRP(mg/L), serum Amylase(U/L), serum Lipase(U/L), Drain Amylase(U/L), Drain Lipase(U/L)	1 month after surgery
Secondary	Surgical outcome: pain score	Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').	1 month after surgery
Secondary	Surgical outcome: hospital stay(day)		1 month after surgery
Secondary	Surgical outcome: readmission rate(%)		1 month after surgery
Secondary	Surgical outcome: serum CRP(mg/L)		1 month after surgery
Secondary	Surgical outcome: serum Amylase(U/L)		1 month after surgery
Secondary	Surgical outcome: serum Lipase(U/L)		1 month after surgery
Secondary	Surgical outcome: Drain Amylase(U/L)		1 month after surgery
Secondary	Surgical outcome: Drain Lipase(U/L)		1 month after surgery
Secondary	Duration of use for each surgical instruments	Duration for each surgical instruments	during the operation
Secondary	number of use for each surgical instruments	number of use for each surgical instruments	during the operation