Gastric Cancer
Conditions
Keywords
Gastric cancer，Laparoscopic distal gastrectomy
Brief summary
The aim of this study is comparing the short-term quality of life between laparoscopy-assisted distal gastrectomy and totally laparoscopic distal gastrectomy for gastric cancer.
Interventions
PROCEDURElaparoscopy-assisted distal gastrectomy Group
LADG
TLDG
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 20-80 years; 2. Patients had an Eastern Cooperative Oncology Group performance status score of 0 or 1; 3. Patients had histologically confirmed gastric adenocarcinoma (tumor size\<5cm) at clinical stage I-III with T1-4aN0-2M0 excluding T4b or N3 tumors, according to the of the American Joint Committee on Cancer classification system, eighth edition; 4. Patients were expected to undergo laparoscopic distal gastrectomy with D2 lymphadenectomy.
Exclusion criteria
1. Patients had bulky regional lymph nodes (larger than 3 cm at the long diameter) or possible distant metastasis in preoperative evaluation 2. Patients had history of chemotherapy, radiotherapy, immunotherapy or target therapy; 3. Patients had any concurrent or previous malignant tumor; 4. Patients had unstable cardiovascular, respiratory, kidney, or liver disease and poorly controlled hypertension, diabetes, mental disorders; history of upper abdominal surgery (except laparoscopic cholecystectomy). 5. Patients were histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire | 30 days postoperatively | Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire at 30 days postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scores on the other scales of EORTC QLQ-C30 questionnaire postoperatively | 30 days postoperatively | Scores on the other scales of EORTC QLQ-C30 questionnaire at 30 days postoperatively |
| Scores on EORTC QLQ-C30 questionnaire | 7 days and 90 days postoperatively | Scores on EORTC QLQ-C30 questionnaire at 7 days and 90 days postoperatively |
| Scores on the scales of EORTC QLQ-STO22 questionnaire postoperatively | 7，30 and 90 days postoperatively | Scores on the scales of EORTC QLQ-STO22 questionnaire at 7，30 and 90 days postoperatively |
| hospital stay cost | 30-day | — |
| Intraoperative and postoperative morbidities and mortality | 90-day | — |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORDazhi Xu, PHD, MD
Fudan University
Outcome results
None listed