Long-term Incisional Hernia Rate After Single-Incision Laparoscopic Cholecystectomy (SILC) in Front of Standard Laparoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- incisional hernia rate
研究概览
简要总结
Single-incision laparoscopic cholecystectomy (SILC) requires a larger incision than standard laparoscopy, which may increase the incidence of incisional hernias.
This study evaluated SILC and standard multiport cholecystectomy with respect to perioperative outcomes, hospital stay, cosmetic results, and postoperative complications, including the 5-years incisional hernia rate.
详细描述
A cohort study was performed for patients who underwent a laparoscopic cholecystectomy under an institutional review approved protocol. Between 2009 and 2011, 45 unselected patients underwent SILC performed by the same two surgeons.
The study inclusion criteria were the following: patients over 18 years with cholelithiasis, and candidates for elective surgery with no significant cardiopulmonary, hepatic or renal impairment (ASA score less than 4).
The exclusion criteria included the following: acute cholecystitis, associated CBD stones or pancreatitis, an emergency operation for complicated disease, mental illness, or patient refusal and/or absence of informed consent. All included patients signed a standard consent form after being informed about the characteristics of the SILC procedure.
The outcomes of these patients were compared with those of a control cohort series of 140 patients who underwent standard LC (with the same inclusion and exclusion criteria) during the same period.
The primary endpoint of the study was to determine the incisional hernia rate at the umbilical wound after 5 years of follow-up. Hernias were defined as evidence of a hernia at the clinical examination or those confirmed by ultrasound examination in case of clinical doubt.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 over 18 years with cholelithiasis and candidates for elective surgery (cholecystectomy)
- •abscence of significant cardiopulmonary, hepatic or renal impairment (ASA score less than 4)
排除标准
- •acute cholecystitis
- •associated common bile duct stones or pancreatitis
- •emergency operation for complicated disease
- •ASA 4 (American Society of Anesthesiologists)
- •pregnancy
- •mental illness
- •patient refusal and/or absence of informed consent
结局指标
主要结局
incisional hernia rate
时间窗: 5 years
Incisional Hernia by clinical examination or CT scan
次要结局
- postoperative complications 3(Rate of participants suffering from seroma and/or wound infection assesed after 30 days of follow-up)
- operating time of the procedure(During the perioperative period)
- postoperative complications 1(Rate of participants suffering from biliary complication assesed after 30 days of follow-up)
- postoperative complications 2(Rate of participants who needed reoperation assesed after 30 days of follow-up)
- cosmetic satisfaction(patient's own cosmetic evaluation using a visual analogue score ranging from 0 to 10 (0=worst to 10=best) after 30 days of follow-up)