Comparing the Quality of Life Between LADG and TLDG for Gastric Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

443 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2022-02-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Laparoscopic Versus Open Gastrectomy for Gastric Cancer: A Prospective Randomized Trial

NCT00452751

Gastric Cancer

UNKNOWN PHASE3

Comparison of Laparoscopic Proximal Gastrectomy and Laparoscopic Total Gastrectomy

NCT02892643

Gastric Cancer

COMPLETED NA

Efficacy of Laparoscopic Subtotal Gastrectomy With D2 Lymph Node Dissection for Locally Advanced Gastric Cancer

NCT01456598

Gastric Cancer

COMPLETED NA

Effect of Laparoscopy-Assisted Distal Gastrectomy for Locally Advanced Gastric Cancer

NCT02464215

Gastric Cancer

UNKNOWN NA

Clinical Study on Laparoscopic Gastrectomy for Early Gastric Cancer (COACT_0301)

NCT00546468

Gastric Cancer

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Quality of Life Gastric Cancer Surgery Surgical Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized, multi-center trial that comparing surgical complications and Quality of Life between "Totally laparoscopic distal gastrectomy" and "Laparoscopy-assisted distal gastrectomy" in Korea.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TLDG arm

TLDG arm(Totally laparoscopic distal gastrectomy)

: After lymphadenectomy, gastrectomy and reconstruction procedure are performed intracorporeally without mini-laparotomy.

Group Type EXPERIMENTAL

TLDG arm

Intervention Type PROCEDURE

After lymphadenectomy, gastrectomy and reconstruction procedure are performed intracorporeally without mini-laparotomy(TLDG)

LADG arm

LADG arm(Laparoscopy-assisted distal gastrectomy)

: After lymphadenectomy, gastrectomy and reconstruction procedure are performed through mini-laparotomy

Group Type EXPERIMENTAL

LADG arm

Intervention Type PROCEDURE

After lymphadenectomy, gastrectomy and reconstruction procedure are performed extracorporeally through mini-laparotomy(LADG)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TLDG arm

After lymphadenectomy, gastrectomy and reconstruction procedure are performed intracorporeally without mini-laparotomy(TLDG)

Intervention Type PROCEDURE

LADG arm

After lymphadenectomy, gastrectomy and reconstruction procedure are performed extracorporeally through mini-laparotomy(LADG)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No