Fast Track Surgery With Laparoscopic-assisted Gastrectomy for Advanced Gastric
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 主要终点
- food intake time
研究概览
简要总结
The purpose of this study is to to investigate the feasibility and safety of fast-track surgery when combined with laparoscopic-assisted gastrectomy for advanced gastric cancer patients.
详细描述
Methods: We designed a prospective randomized, controlled clinical trial then recruited 61 consecutive advanced gastric cancer patients. (Trial registration number: JLUFHC1722013) Further divide into a fast-track surgery group (n=30) and a conventional surgery group (n=31). Surgical technique in both groups is same laparoscopic-assisted gastrectomy with D2 lymphadenectomy. Compare outcomes includes length of hospital stay, return to normal diet and postoperative complications.Results: Recovery parameters such as the length of time to return to normal diet; to the first defection; start of ambulation time ;the mean hospital stay will be all less in patients assigned to the fast track surgery protocol compared with those in the conventional care programme. Conclusion: We will consider fast-track rehabilitation to be safe and feasible in advanced gastric cancer patients. Moreover, it will result in decreased hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of advanced gastric cancer, elective laparoscopic surgery and age under 75.
排除标准
- •Patients with early gastric cancer, received neoadjuvant chemotherapy, had pyloric obstruction or with distant metastasis were excluded from the study.
研究组 & 干预措施
fast-track surgery
The included patients will be randomly divided to two groups :30 that will undergo LAG with FTS rehabilitation programme and 31 that also will undergo LAG but receive conventional postoperative care.Laparoscopy-assisted gastrectomy will be carried out in this approach.There will be no difference in the surgical procedures of both groups.The criteria for discharge are: tolerance of solid diet, return of bowel habits and ability to walk on their own.
干预措施: fast-track surgery (Procedure)
conventional postoperative care
The included patients will be randomly divided to two groups :30 that will undergo LAG with FTS rehabilitation programme and 31 that also will undergo LAG but receive conventional postoperative care.Laparoscopy-assisted gastrectomy will be carried out in this approach.There will be no difference in the surgical procedures of both groups.The criteria for discharge are: tolerance of solid diet, return of bowel habits and ability to walk on their own.
干预措施: conventional postoperative care (Procedure)
结局指标
主要结局
food intake time
时间窗: within the first 30 days (plus or minus 3 days) after surgery
Ambulation time
时间窗: within the first 30 days (plus or minus 3 days) after surgery
defection time
时间窗: within the first 30 days (plus or minus 3 days) after surgery
次要结局
- Complications(one year)
- readmission(one year)
研究者
Quan Wang
Deputy Director of General Surgery
The First Hospital of Jilin University