Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy, Randomized Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Dumping syndrome
研究概览
简要总结
Billroth-II (gastrojejunostomy) is one of major option after gastrectomy for gastric cancer. The investigators hypothesized that isoperistaltic anastomosis lead to higher incidence of dumping syndrome but antiperistaltic (anisoperistaltic) anastomosis have relevance to gastric stasis or obstruction. The investigators will assess complications, dumping syndrome and quality of life between isoperistaltic and antiperistaltic after distal gastrectomy for gastric cancer.
详细描述
Recently, laparoscopic approach has been a option for gastric cancer, especially early gastric cancer. There are growing interest in quality of life in addition to recurrence or survival. There are few report about peristalsis and no report for quality of life according to a direction of peristalsis.
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
- •Histologically confirmed adenocarcinoma in stomach
- •Scheduled as laparoscopic distal gastrectomy (tumor located lower or middle third)
- •Planned with gastrojejunostomy after gastrectomy
- •Clinical stage T1N0M0 or T2N0M0
- •ECOG 0 or 1 (The Eastern Cooperative Oncology Group)
- •ASA score class I-III (The American Society of Anesthesiologists)
- •patient has given their written informed consent to participate in the study
排除标准
- •Simultaneously combined resection of other organ (including cholecystectomy)
- •Active other malignancy
- •Requiring total gastrectomy
- •Chronic inflammatory bowel disease or other chronic disease related to bowel motility
- •Uncontrolled diabetes or patients with diabetic complications
- •Vulnerable patients
研究组 & 干预措施
Isoperistaltic
Same direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the distal part of remnant stomach
干预措施: Isoperistaltic (Procedure)
Antiperistaltic
Reverse direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the proximal part of remnant stomach
干预措施: Antiperistaltic (Procedure)
结局指标
主要结局
Dumping syndrome
时间窗: 12 months
Using Sigstad's score
次要结局
- long-term complication(from 1 month to 12 months)
- Total score of quality of life questionnaire(12 months)
- Gastritis(12 months)
- Body weight change(12 months)
- Surgical complication(within 1 month)
研究者
Seung Wan Ryu
Director of Gastrointesinal surgery, professor
Keimyung University Dongsan Medical Center