Estudio Prospectivo Aleatorizado de la colecistectomía laparoscópica Por Puerto único vs colecistectomía laparoscópica Por Cuatro Puertos en Pacientes Con Colelitiasis sintomática y régimen de cirugía Sin Ingreso.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 主要终点
- evolution of postoperative pain
研究概览
简要总结
Background: Single-incision laparoscopic cholecystectomy (SILC) is increasingly being used as a minimally invasive surgery with potential benefits over 4-port laparoscopic cholecystectomy (LC) in terms of postoperative pain and faster recovery.
Methods: Seventy-three patients with symptomatic cholelithiasis were randomized to SILC (n=37) or LC (n=36). Data measures included operative details, adverse events, postoperative pain and analgesic requirements, success of the ambulatory process, return to normal activity and return to work, cosmetic results and quality of life score.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age higher than 18 and lower than 80
- •American Society of Anesthesiologists class (ASA) I-II,
- •absence of any previous anesthetic complication,
- •accompaniment by a responsible adult during 24 hours,
- •symptomatic gallstones candidate to cholecystectomy
- •and a signed informed consent.
排除标准
- •a Body Mass Index (BMI) higher than 35,
- •any laparoscopic contraindication,
- •acute cholecystitis background, suspect of Mirizzi's Syndrome, common duct stones or malignancy,
- •anti-inflammatory allergy
- •psychiatric history that could hinder ambulatory procedure
研究组 & 干预措施
Single Incision Cholesystectomy (SILC)
Single Incision Laparoscopic Cholecystectomy (SILC): The umbilicus is grasped and a 2 cm vertical skin and fascial incision is performed. A multiport (TriPort®) is inserted under direct vision. Principles of cholecystectomy are the same as traditional laparoscopic cholecystectomy.
干预措施: Single Incision Laparoscopic Cholecystectomy (SILC) (Procedure)
Four Ports Cholecystectomy (4PCL)
Four Ports Conventional laparoscopic cholecystectomy (4PCL): A 10mm supraumbilical incision is made and the pneumoperitoneum insufflated through a Veress needle. 4 ports are introduced: 2 of 10mm in supraumbilical and left flank and 2 of 5mm in epigastric and right flank.
干预措施: Four Ports Laparoscopic Cholecystectomy (4PLC) (Procedure)
结局指标
主要结局
evolution of postoperative pain
时间窗: 2, 4, 6 and 8 postoperative hours, 1, 3, 7 and 30 days after surgery
次要结局
未报告次要终点