Comparison of Safety and Clinical Effects of Straight and Articulated Instruments (ArtiSential) in Laparoscopic Gastrectomy for Gastric Cancer Patients, a Prospective Randomized Study

NACompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

June 22, 2022

Primary Completion Date

December 15, 2023

Study Completion Date

December 31, 2023

Conditions
Gastric Adenocarcinoma Patients, Who Are Scheduled for Laparoscopic Radical Gastrectomy
Interventions
PROCEDURE

Articulating (experimental group)

1\. Surgical procedure On the day of surgery, random allocation to either the experimental or the control group will be perfored just before the start of the procedure. All of the surgery will be conducted laparoscopically. The control group will undergo surgery using a conventional straight laparoscopic instrument, while the experimental group will use an articulating instrument. The surgical procedure will be the same for both groups. The total time of surgery and the time spent on the supra-pancreatic lymph node dissection will be recorded during the procedure. The estimated blood loss during surgery will be also measured.

PROCEDURE

Control (control group)

"2\. Postoperative follow-up Patients participating in this study will have the same postoperative care as those not participating in this study. To compare the degree of pancreatic injury, amylase and lipase levels will be measured in the serum and the peritoneal fluid frome the drainage on postoperative days 1 and 3.~Postoperative complications will be classified and recorded according to the Clavien-Dindo classification for all complications occurring within 30 days after surgery. The dissected lymph nodes will be categorized by region, and the number of dissected lymph nodes will also be confirmed."

Trial Locations (1)

Unknown

GangnamSeverance Hospital, Seoul

All Listed Sponsors
lead

Gangnam Severance Hospital

OTHER