Korea University Anam Hospital
Seoul, 02841, South Korea
NCT Number: NCT03393182
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.
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Notify Me20 year–80 year
All sexes
Interventional
Not applicable
Seoul, 02841, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After lymphadenectomy, gastrectomy and reconstruction procedure are performed intracorporeally without mini-laparotomy(TLDG)
After lymphadenectomy, gastrectomy and reconstruction procedure are performed extracorporeally through mini-laparotomy(LADG)
Time frame: Postoperative 30-day
Check the morbidity rate
:Wound, seroma, hematoma, wound infection, wound dehiscence, wound evisceration, Fluid collection/Abscess, Intraabdominal bleeding, Intraluminal bleeding, Postoperative ileus, Anastomosis stenosis, Anastomosis leakage, Pancreatitis or pancreatic fistula, Complication(Pulmonary, Urinary, Renal, Hepatic, Cardiac, Endocrine) etc.
Time frame: screening(pre op) / Postoperative 30-day,3-month,6-month,12-month
EORTC QLQ-C30/STO22
Korea University Anam Hospital
Other
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)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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