A multi-center randomized controlled trial comparing the safety between reduced-port and conventional laparoscopic distal gastrectomy for early gastric cancer (KLASS-12)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006935

Enrollment

348

Registered

2022-01-18

Start date

2022-05-25

Completion date

Unknown

Last updated

2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : The number of ports during surgery

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed with adenocarcinoma in endoscopic biopsy before surgery. 2) Patients aged 20 to 85 years old. 3) Patients with a clinical stage evaluated by preoperative endoscopy (or endoscopic ultrasound) and CT examination with T1N0M0 by 8th AJCC gastric cancer staging system 4) Laparoscopic distal gastrectomy and lymph node resection above D1+ are scheduled, and patients who can undergo radical surgery by this procedure. 5) A patient who fully explained the purpose and contents of the test before participating in the test and signed a written consent form approved by the Institutional Research Ethics Review Committee to participate in this study according to his free will.

Exclusion criteria

Exclusion criteria: 1) History of abdominal surgery including gastrectomy (excluding laparoscopic appendectomy and laparoscopic cholecystectomy) 2) If combine resection is expected (Cholecystectomy is possible) 3) A patient who received chemotherapy or radiation treatment before surgery for gastric cancer diagnosed this time. 4) Patients who underwent surgery or chemotherapy for other organ primary cancer within the last 5 years (excluding completely cured skin basal cell carcinoma and in situ cervical cancer) 5) Vulnerable subjects (those who lack medical ability, pregnant women, or those who are planning to conceive) 6) Patients who have participated in other clinical trials within the last 6 months or are currently participating

Design outcomes

Primary

Measure	Time frame
The incidence of complications 30 days after surgery	—

Secondary

Measure	Time frame
Comparison of surgical results and pain assessment other than complications	—

Countries

Korea, Republic of

Contacts

Public ContactHo Seok SEO

The Catholic University of Korea, Seoul St. Mary's Hospital

comaguitar@gmail.com+82-2-2258-6615

Outcome results