Clinical Impact of Routine Abdominal Drainage After Laparoscopic Cholecystectomy. A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- pain, nausea and vomiting
研究概览
简要总结
Patients and methods: 100 patients were included in this study. They divided into two groups, group (A) with drain and group (B) without drain. The investigators recorded the effect of drainage on, postoperative pain (Po-P) using visual analogue scale VAS at 6, 24, 48 hours and 1 week postoperative nausea/vomiting at 6, 24, 48 hours postoperative, abdominal collection, hospital stay, chest complication, and postoperative body temperature.
详细描述
The patients were randomized into two groups using enclosed envelope. Group (A) with drain included 50 patients, and group (B) without drain included 50 patients.
Under general anesthesia, and same antibiotics (3rd generation cephalosporin) Surgery was performed using conventional four ports umbilical port, port below xiphoid and two ports below right costal margin. Pneumoperitonum at pressure 12 mmHg. In group A nelton catheter (no 20) was inserted at the end of operation.
The Intraoperative parameter observed included duration of the operation, amount of CO2 used in the operation, bile escape, saline irrigation during operation and volume of blood loss were recorded.
The patients started oral feeding 8 hours (h) postoperatively; abdominal ultrasound was done for all patients in both groups on day of discharge to show any collection or free fluid in the abdomen. The patients were usually discharged after removal of drain, and when the patient surgically free.
Postoperative pain was evaluated at 6 h, 24 h, 48, 1 week after operation using a visual analog scale (VAS) with which each patients noted the severity of pain at each evaluated time using a linear between zero (no pain) and 10 (severe pain). Postoperative analgesia in the form of non steroidal anti-inflammatory drug (NSAID) was administered intramuscularly when required. If the patients still complained of pain and required strong analgesic, (1 mg/kg pethidine intramuscularly) was administered. The total dose of these medications were recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with gallbladder stones and laparoscopic cholecystectomy
排除标准
- •patients above 80 years old
- •patients with acute cholecystitis
- •patients with history of upper laparotomy
- •patients with a hemorrhagic tendency due to cirrhosis
- •patients refused to give informed consent and patients who were converted to open cholecystectomy
结局指标
主要结局
pain, nausea and vomiting
时间窗: 30 days postoperative
次要结局
未报告次要终点
