Articulated Laparoscopic Instruments Clinical Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| LC laparoscopic surgery using conventional laparoscopic instruments |
Device: Minimally Invasive Surgery
gynecological, urologic, thoracic, plastic and reconstructive and ENT etc. endoscopic and laparoscopic surgical procedures
Other Names:
|
| LW Using wristed laparoscopic instruments (Artisential Maryland dissector, Artisential Fenestrated gasper) |
Device: Minimally Invasive Surgery
gynecological, urologic, thoracic, plastic and reconstructive and ENT etc. endoscopic and laparoscopic surgical procedures
Other Names:
|
| 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 |
Outcome Measures
Primary Outcome Measures
- complication [1 month after surgery]
One of the most important surgical outcome, complication will be measured at 1 month after surgery
Secondary Outcome Measures
- Surgical outcome: operative time(min) [1 month after surgery]
- 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: 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: hospital stay(day) [1 month after surgery]
- Surgical outcome: readmission rate(%) [1 month after surgery]
- Surgical outcome: serum CRP(mg/L) [1 month after surgery]
- Surgical outcome: serum Amylase(U/L) [1 month after surgery]
- Surgical outcome: serum Lipase(U/L) [1 month after surgery]
- Surgical outcome: Drain Amylase(U/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
- number of use for each surgical instruments [during the operation]
number of use for each surgical instruments
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients with gastric cancer shcedulled for gastrectomy
Exclusion Criteria:
Vulnerable subject (illiterate, pregnant)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yonsei University Health System, Severance Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Yonsei University
Investigators
- Principal Investigator: Hyoung-Il Kim, Yonsei University Health System, Severance Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4-2022-0414