Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Postoperative Pain and Analytic Acute Phase Reactants Following Laparoscopic Sleeve Gastrectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Postoperative pain
研究概览
简要总结
A prospective, randomized study will be performed in patients undergoing laparoscopic sleeve gastrectomy (LSG) as bariatric procedure. The patients will be randomized into 2 groups: those patients undergoing an intra-abdominal lavage with normal saline (Group 1) and those undergoing an intra-abdominal lavage with a gentamicin-clindamycin solution (Group 2). Postoperative pain and C reactive protein will be investigated 24 hours after surgery.
详细描述
A prospective, randomized study will be performedin patients undergoing laparoscopic sleeve gastrectomy (LSG) as bariatric procedure. The patients will be randomized into 2 groups: those patients undergoing an intra-abdominal lavage with normal saline (Group 1) and those undergoing an intra-abdominal lavage with a gentamicin-clindamycin solution (Group 2). Postoperative pain and C reactive protein will be investigated 24 hours after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) >40 Kg/m2
- •BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity
- •Patients undergoing laparoscopic sleeve gastrectomy (LSG) as bariatric procedure.
排除标准
- •Gastroesophageal reflux
- •Preoperative diagnosis of chronic renal failure
- •Uncontrolled psychiatric disorders
- •Active infections
- •Malignancies
- •Any other concomitant pathology considered as a contraindication for bariatric surgery.
研究组 & 干预措施
Normal saline irrigation
An irrigation of the entire abdominal cavity with 500 ml normal saline will be performed.
干预措施: Normal saline irrigation (Drug)
Clindamycin-gentamicin irrigation
An irrigation of the entire abdominal cavity with 500 ml gentamicin and clyndamycin solution will be performed.
干预措施: Clindamycin-gentamicin irrigation (Drug)
结局指标
主要结局
Postoperative pain
时间窗: 24 hours after surgery
Postoperative pain will be evaluated by a Visual Analogic Scale 24 hours after surgery
次要结局
- C reactive protein(24 hours after surgery)
研究者
Jaime Ruiz-Tovar, MD, PhD
Jaime Ruiz-Tovar, MD, PhD
Hospital General Universitario Elche