Surgical and Oncologic Outcomes After Curative D2 vs D1 Gastrectomy in Operable Gastric Carcinoma, A Randomized Controlled Study in Egyptian Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Postoperative morbidity rate
研究概览
简要总结
Gastric carcinoma is the second most common cause of cancer-related deaths and its main treatment modality if potentially curable is surgery but the optimal surgical resection is controversial. The aim of the current study was to assess the outcomes of curative D2 compared to D1 gastrectomy of operable gastric carcinoma regarding postoperative morbidity and mortality, disease recurrence and survival rates.
详细描述
80 consecutive patients with potentially operable gastric carcinoma were randomized via concealed envelopes into 2 groups (each included 40 patients), group I managed by radical gastrectomy with D1 lymphadenectomy while group II managed by radical gastrectomy with D2 lymphadenectomy . Both groups were compared regarding postoperative mortality, morbidities, tumor recurrence and 2 years survival rates.
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
- Double (Participant, Care Provider)
盲法说明
Randomization by opaque sealed envelopes
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed gastric carcinoma
- •Potentially operable gastric carcinoma without evidence of distant metastasis
排除标准
- •Complicated gastric cancer (obstructed or perforated)
- •Locally irresectable tumor
- •Previous or coexisting cancer
- •Prior gastric surgery or neoadjuvant chemotherapy
- •Contraindication for major surgery
结局指标
主要结局
Postoperative morbidity rate
时间窗: 30 days after surgery
Frequency of early postoperative complications
Operative mortality rate
时间窗: Within 30 days after surgery
Frequency of early postoperative mortality
次要结局
- 2 years Recurrence rate(2 years after surgery)
- 2 years Cancer specific mortality rate(2 years after surgery)
- 2 years Disease free survival rate(2 years after surgery)
- 2 years Overall survival rate(2 years after surgery)
研究者
Mohamed El Messiry
Ass. Professor
University of Alexandria