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

Not Applicable

Completed

• Conditions: Quality of Life; Gastric Cancer; Surgery; Surgical Complication
• Interventions: Procedure: LADG arm; Procedure: TLDG arm

• Registration Number: NCT03393182
• Lead Sponsor: Korea University Anam Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-01-02
• Study First Posted: 2018-01-08
• Study Start: 2018-03-01
• Primary Completion: 2021-08-18
• Study Completion: 2022-02-18
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 443

Inclusion Criteria

• Histologic proven gastric adenocarcinoma (by preoperative gastrofiberscopy)
• Age between 20 and 80 years old
• Eastern Cooperative Oncology Group performance statu of 0 or 1
• Clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) according to the 7th edition of the American Joint Committee on Cancer system10 (Clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography)
• Scheduled for laparoscopic distal gastrectomy with D1+ or D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese Gastric Cancer Treatment Guidelines 2010 (ver.3).)
• Patients who gave a consent and signed the formal paper permitted by Institutional Review Board (IRB) after hearing a full description of the study (purpose and contents) prior to the participation

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Exclusion Criteria

• Patients who received stomach surgery (i.e. gastrectomy or gastrojejunostomy) in the past
• Patients with intraabdominal adhesion due to previous intraperitoneal surgery
• Patients who recently diagnosed with gastric cancer and received either anticancer treatment or radiation therapy
• Patients who requires combined organ resection due to aggression of gastric cancer or other diseases
• Patients who received surgeries due to primary cancer of other organs, or had anticancer treatment or radiation therapy in the last five years (patients whose skin basal cell carcinoma and insitu cervical cancer are completely cured are exceptions).
• Vulnerable people who can't communicate or are pregnant (or planning to be pregnant)
• Patients who are currently participating or participated in other clinical trials in the last six months.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LADG arm	LADG arm	LADG arm(Laparoscopy-assisted distal gastrectomy) : After lymphadenectomy, gastrectomy and reconstruction procedure are performed through mini-laparotomy
TLDG arm	TLDG arm	TLDG arm(Totally laparoscopic distal gastrectomy) : After lymphadenectomy, gastrectomy and reconstruction procedure are performed intracorporeally without mini-laparotomy.

Primary Outcome Measures

Name	Time	Method
Postoperative 30-day morbidity rate	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.

Secondary Outcome Measures

Name	Time	Method
QOL measurement : EORTC QLQ-C30/STO22	screening(pre op) / Postoperative 30-day,3-month,6-month,12-month	EORTC QLQ-C30/STO22

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of