Comparison of laparoscopic totally extraperitoneal hernia repair with and without prophylactic antibiotics: A randomized controlled study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of SSI (evidenced by development of redness, swelling, discharge or increase in pain over staple line in a period of 30 days post op) as defined by CDC classification.
研究概览
简要总结
Despite extensive research in literature regarding randomized controlled studies evaluating the efficacy of prophylactic antibiotics in laparoscopic totally extraperitoneal repair (TEP), we were unable to find any. The only studies were observational or evaluated the role in open inguinal hernia repairs.Hence, the present study was designed to assess the role of prophylactic antibiotics in laparoscopic inguinal hernia repair.The Guidelines of the European Hernia Society for the treatment of inguinal hernia concluded that antibiotic prophylaxis does not significantly reduce the number of wound infection.
This is a randomized placebo-controlled study designed to evaluate the role of prophylactic antibiotics in laparoscopic totally extraperitoneal hernia repair at a single center in New Delhi, India. The primary outcome measures will be occurence of surgical site infection (CDC classification) .The secondary outcomes will be post operative complications, post operative pain , duration of hospital stay and patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients of symptomatic inguinal hernia presenting to surgery outpatient department at Lok Nayak Hospital, New Delhi and planned for laparoscopic inguinal hernia surgery.
排除标准
- •Recurrent inguinal hernia,
- •Antibiotic intake 48 hours prior to surgery ,
- •Evidence of diabetes mellitus, other immunocompromised states and conversion to open procedure and
- •Pregnancy or lactation.
结局指标
主要结局
Incidence of SSI (evidenced by development of redness, swelling, discharge or increase in pain over staple line in a period of 30 days post op) as defined by CDC classification.
时间窗: At 48hrs,1week,2week,4 weeek
次要结局
- Post operative pain using Visual Analogue(Scale (VAS) score)
- Duration of hospital stay(Pre, intra and post procedure)
- Patient satisfaction (Likert scale)(At discharge, 1 week, 4 weeks)
- Post operative complications (Clavien Dindo classification)(48hours, 1 week,2 week, 4 weeks)
研究者
Dr Ananya Dilip
Maulana Azad Medical College and Associated Lok Nayak Hospital