NCT03393182

Comparing the Quality of Life Between LADG and TLDG for Gastric Cancer_KLASS07 (CKLASS01)).

A Multicenter Randomized Controlled Trial Comparing the Quality of Life Between Laparoscopy-assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy for Gastric cancer_KLASS 07 (CKLASS01)(Korea-China Collaborated Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 443 (actual)
• Sponsor: Korea University Anam Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The present randomized study is designed to compare the quality of life between the patients undergoing laparoscopy-assisted and totally laparoscopic distal gastrectomy for gastric cancer, and therefore to evaluate the superiority of totally laparoscopic distal gastrectomy to laparoscopy-assisted distal gastrectomy.

Detailed description

The primary endpoint of this trial is the early postoperative morbidity, that is defined as complications that occur within 30 days after surgery. Early postoperative morbidity is classified as follows: (1) wound morbidity (2) surgical site morbidity: anastomosis bleeding or leakage, duodenal stump leakage, postoperative bleeding, afferent loop or efferent loop obstruction, etc.; (3) lung morbidity: atelectasis, pleural effusion, empyema, pneumothorax, etc.; (4) intestinal obstruction morbidity (5) urinary tract morbidity (6) intra-abadominal abscess (7) postoperative pancreatitis (8) pancreatic fistula (9) intestinal fistula 10) others: lymphorrhea, diarrhea, etc. The secondary end point is the questionnaire score regarding QOL. This is assessed by the Korean versions of the EORTC QLQ-C30 (version 3.0) and STO22 questionnaires.

Conditions

• Quality of Life
• Gastric Cancer
• Surgery
• Surgical Complication

Interventions

Type	Name	Description
PROCEDURE	TLDG arm	After lymphadenectomy, gastrectomy and reconstruction procedure are performed intracorporeally without mini-laparotomy(TLDG)
PROCEDURE	LADG arm	After lymphadenectomy, gastrectomy and reconstruction procedure are performed extracorporeally through mini-laparotomy(LADG)

Timeline

• Start date: 2018-03-01
• Primary completion: 2021-08-18
• Completion: 2022-02-18
• First posted: 2018-01-08
• Last updated: 2022-04-13

Locations

1 site across 1 country: South Korea