A Multi-center Prospective Randomized Controlled Trial Comparing the Quality of Life Between Laparoscopic-assisted Distal Gastrectomy (LADG) and Totally Laparoscopic Distal Gastrectomy (TLDG) for Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 2
- 主要终点
- Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire
研究概览
简要总结
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.
详细描述
Although totally laparoscopic distal gastrectomy (TLDG) and laparoscopic-assisted distal gastrectomy (LADG) are both minimally invasive surgeries for gastric cancer with the same surgical treatment principles, in the former, all surgical processes are performed intracorporeally, while, in the latter, extracorporeal gastro-enteric anastomosis is achieved. Whether the procedural differences between TLDG and LADG affect quality of life （QOL）is still under debate.To evaluate how each laparoscopic surgery affect QOL of patients with gastric cancer, it is necessary to compare the postoperative QOL (scoring by questionnaire) between the patients undergoing TLDG and LADG through a multi-center randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 20-80 years;
- •Patients had an Eastern Cooperative Oncology Group performance status score of 0 or 1;
- •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;
- •Patients were expected to undergo laparoscopic distal gastrectomy with D2 lymphadenectomy.
排除标准
- •Patients had bulky regional lymph nodes (larger than 3 cm at the long diameter) or possible distant metastasis in preoperative evaluation
- •Patients had history of chemotherapy, radiotherapy, immunotherapy or target therapy;
- •Patients had any concurrent or previous malignant tumor;
- •Patients had unstable cardiovascular, respiratory, kidney, or liver disease and poorly controlled hypertension, diabetes, mental disorders; history of upper abdominal surgery (except laparoscopic cholecystectomy).
- •Patients were histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy).
研究组 & 干预措施
Totally laparoscopic distal gastrectomy
The patients who are allocated to TLDG group undergo intracorporeal anastomosis for the recovery of gastrointes- tinal continuity after gastrectomy.
干预措施: Totally laparoscopic distal gastrectomy (Procedure)
Laparoscopy-assisted distal gastrectomy
The patients who are assigned to LADG group undergo extracorporeal anasto- mosis for gastrointestinal reconstruction.
干预措施: laparoscopy-assisted distal gastrectomy Group (Procedure)
结局指标
主要结局
Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire
时间窗: 30 days postoperatively
Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire at 30 days postoperatively
次要结局
- hospital stay cost(30-day)
- Intraoperative and postoperative morbidities and mortality(90-day)
- Scores on the other scales of EORTC QLQ-C30 questionnaire postoperatively(30 days postoperatively)
- Scores on EORTC QLQ-C30 questionnaire(7 days and 90 days postoperatively)
- Scores on the scales of EORTC QLQ-STO22 questionnaire postoperatively(7，30 and 90 days postoperatively)