Articulated Laparoscopic Instruments Clinical Study
- Conditions
- Gastric Cancer
- Interventions
- Device: Minimally Invasive Surgery
- Registration Number
- NCT05550974
- Lead Sponsor
- Yonsei University
- 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1155
Patients with gastric cancer shcedulled for gastrectomy
Vulnerable subject (illiterate, pregnant)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description LC Minimally Invasive Surgery laparoscopic surgery using conventional laparoscopic instruments LW Minimally Invasive Surgery Using wristed laparoscopic instruments (Artisential Maryland dissector, Artisential Fenestrated gasper)
- Primary Outcome Measures
Name Time Method complication 1 month after surgery One of the most important surgical outcome, complication will be measured at 1 month after surgery
- Secondary Outcome Measures
Name Time Method Surgical outcome: pain score 1 month after surgery 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').
Surgical outcome: serum CRP(mg/L) 1 month after surgery Surgical outcome: Drain Lipase(U/L) 1 month after surgery Duration of use for each surgical instruments during the operation Duration for each surgical instruments
Surgical outcome: bleeding(ml) 1 month after surgery 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)
Surgical outcome: serum Lipase(U/L) 1 month after surgery Surgical outcome: Drain Amylase(U/L) 1 month after surgery Surgical outcome: hospital stay(day) 1 month after surgery Surgical outcome: readmission rate(%) 1 month after surgery Surgical outcome: serum Amylase(U/L) 1 month after surgery Surgical outcome: operative time(min) 1 month after surgery number of use for each surgical instruments during the operation number of use for each surgical instruments
Trial Locations
- Locations (1)
Yonsei University Health System, Severance Hospital
🇰🇷Seoul, Korea, Republic of