Bipolar Electrosurgery Versus Thermocautery in Circumcision With Safe Anesthetic Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mean and Standard deviation of postoperative analgesic doses (mean±SD)
研究概览
简要总结
Background: Circumcision is the most commonly performed surgical procedure done among the pediatric age group worldwide and is considered to be one of the oldest operations done. Circumcision should be performed properly with safe surgical techniques, with the least possibility of complications.
Objective: To compare bipolar electrosurgery versus thermocautery in the circumcision of infants under combined general and local anesthesia.
Patients and Methods: This prospective randomized comparative study was carried out on 110 infants who were candidates for elective circumcision under combined general and local anesthesia. Infants were randomly allocated into two equal groups (55 infants each); in group A, circumcised by bone-cutting forceps with cutting foreskin using a scalpel and achievement of hemostasis using bipolar electrosurgery, and in group B, circumcised by bone-cutting forceps with cutting foreskin and achievement of hemostasis using thermocautery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 12 Months（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Infants of families who applied for circumcision
- •Age from 1 to 12 months, of the male sex
- •Infants should have normal preoperative laboratory investigations
排除标准
- •Infants with congenital malformations especially hypospadias and epispadias, congenital inguinal hernia, and undescended testis
- •Infants with acute penile infection, or excess suprapubic fat
- •Infants with cardiovascular, neurological, respiratory, liver, renal, endocrine, blood, or immune diseases
- •Allergy to any drug will be used in this study
结局指标
主要结局
Mean and Standard deviation of postoperative analgesic doses (mean±SD)
时间窗: 72 hours after the end of the operation
Number of analgesic doses given after the end of the operation
次要结局
- Mean and Standard deviation of Operative duration (minutes) (mean±SD)(2 minutes after the end of the operation)
- Number of participants and Rate of Intraoperative complications(2 minutes after the end of the operation)
- Number of participants and Rate of Postoperative complications(4 weeks after the end of the operation)