Trial Information

Prospective Randomized Trial of Laparoscopy-assisted Distal Gastrectomy (LADG) Versus Open Distal Gastrectomy (ODG) in Patients With Early Gastric Cancer (EGC)

1. Randomization

Randomization is done by person who is not involved in study. So it is done by the
person in Center for Clinical Trial in National Cancer Center. The patient is enrolled
in the out-patient clinic after getting informed consent of the clinical study from the
patient. Surgeon factor is not considered as a randomization factor because this
clinical study will be performed intramurally. In Center for Gastric Cancer, National
Cancer Center, Surgical techniques and extent of resections are generally standardized
and surgical outcomes are same in terms of complication and recovery.

2. Follow-up schedule

Patients are followed up in the outpatient department at four weeks, three months, six
months, and twelve months after the operation, and every six months thereafter. On each
visit, history was reviewed and physical examination was done. A complete blood count
(CBC) and serum chemistry were evaluated also. An esophago-gastro-duodenoscopy (EGD)
was performed at three months after the operation and yearly thereafter. Abdominal
computed tomography (ACT) was evaluated annually.

3. Assessment of QOL The European EORTC QLQ-C30 (version 3.0) questionnaire is a 30-item
cancer-specific integrated system for assessing the health-related QOL of cancer
patients. The questionnaire incorporates five scales of function (physical, role,
cognitive, emotional and social), three symptom scales (fatigue, pain and nausea and
vomiting), a global health and QOL scale, and single items for the assessment of
additional symptoms commonly reported by cancer patients (e.g., dyspnea, appetite loss,
sleep disturbance, constipation and diarrhea), as well as the perceived financial
impact of the disease and treatment. All items were scored on four-point Likert scales,
with the exception of two items in the global health QOL scale, which used modified
seven-point linear analog scales. The EORTC QLQ-STO22 with a 22-item stomach
cancer-specific questionnaire was also used. It incorporates five hypothesized
scales—(dysphasia, eating restrictions, pain, reflux and anxiety) and four single items
(having a dry mouth, body image, taste, and hair loss) covering disease and
treatment-related symptoms and specific emotional consequences of gastric cancer.12 All
instruments of the questionnaire were administered preoperatively and postoperatively
at seven days, 30 days, 90 days and yearly. Those time points were chosen at usual
follow-up schedule for every gastrectomized patients in our institute, to maximize
compliance for the questionnaire, and to compare other parameters at the same time.

4. Statistical analyses The EORTC QLQ-C30 symptom subscale and the EORTC QLQ-STO22
subscale scores are reported using a scale from 0 to 100. Statistical analyses of the
QOL outcomes evaluated the differences between the LADG and the ODG groups with respect
to the overall changes from the preoperative scores (baseline) to those obtained at
follow-up. To adjust for possible baseline differences, we included the baseline values
in the model. All comparisons between groups were based on 'intent-to-treat' analyses
in which patients were analyzed according to their assigned treatment group.
Categorical variables were compared using the χ2 test, and continuous variables were
analyzed using the Student's t-test. Analysis of Covariance (ANCOVA) with repeated
measures was used to compare the two groups of patients with respect to overall changes
in their short term quality of life after the surgery. The SAS (SAS Institute Inc.,
Cary, NC, USA) program called 'PROC GLM' was used.