A Prospective Case-control Study Comparing the Effects of Open and Laparoscopic Gastrointestinal Surgery on Gastrointestinal Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 401
- 试验地点
- 1
- 主要终点
- Time to first flatus
研究概览
简要总结
A prospective study to compare the postoperative ileus in open and laparoscopic gastrointestinal surgery through the determination of the time the patient takes to pass flatus, pass stool, bowel movement, oral intake, the time of hospital stay and total hospital costs. Postoperative ileus (POI) is one of the major focus of concern for surgeons, hospital executives, quality assurance directors as well as patients because of its role in causing patient distress, discomfort, and morbidity, leading to an increase in the duration of hospital stay and cost of care.
详细描述
All patients aged ≥18 years scheduled to undergo gastric and colorectal cancer resection surgery at the Department of Gastrointestinal Surgery, West China Hospital between 2019 to 2020 will be screened for eligibility. The inclusion criteria for the study will be the patient undergoing elective gastric cancer surgery, have the American Society of Anesthesiologist (ASA) grade ≤ III, alert consciousness, and BMI, and accurate preoperative diagnosis of gastric adenocarcinoma on the basis of computed tomography CT scan report, Gastroscopy and Histopathological reports. Exclusion criteria will be those who cannot participate in study assessments owing to the language barrier, dementia or postoperative delirium; previously received palliative surgery, develops early postoperative bowel obstruction, Anastomotic leakage or Gastroparesis, those requiring reoperation for any other indication before the commencement of formal assessment for PPOI. Those requiring more than 30 minutes of adhesiolysis. Each patient will be approached during preoperative counseling on an individual basis by one of the authors (YZ)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥18 years scheduled to undergo elective abdominal surgery
- •American Society of Anesthesiologist (ASA) grade ≤ III
- •Alert consciousness
- •Accurate preoperative diagnosis on the basis of necessary reports
排除标准
- •Cannot participate in study assessments owing to the language barrier, dementia or postoperative delirium
- •Previously received palliative surgery
- •Develops early postoperative bowel obstruction, Anastomotic leakage or Gastroparesis
- •Those requiring reoperation for any other indication before the commencement of formal assessment for POI
- •Those requiring more than 30 minutes of adhesiolysis
- •Emergency cases
- •American Society Anesthesia (ASA) class IV or V patients, pregnancy, patient with abdominal carcinomatosis or radiation enteritis, inoperable cases due to metastasis, patients simultaneously enrolled in any other competing for clinical study and violation of study protocol by the patient or patient care team
结局指标
主要结局
Time to first flatus
时间窗: up to 1-4 Days after surgery
The time between end of surgery and passage of first flatus
Length of hospital stay
时间窗: up to 1-10 Days after surgery
The time between end of surgery and written discharge ticket
次要结局
- Time to first bowel movement(up to 1-6 Days after surgery)
- Time to first oral intake(up to 1-6 Days after surgery)
- Time to first defecation(up to 1-6 Days after surgery)
- Time to first ambulation(up to 1-6 Days after surgery)
研究者
Yong Zhou
Clinical Professor
West China Hospital