Plastibell Versus Conventional Dissection Techniques for Circumcision in Infants
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Questionnaire for Parental satisfaction (overal esthetic outcome)
研究概览
简要总结
Outcome of circumcision with Plastibell or conventional dissection techniques in infants and children: A prospective randomized controlled trial
Aim: to evaluate and compare postoperative and esthetic outcomes after Plastibell and conventional dissection circumcision
Methods:
Randomized Controlled Trial Inclusion criteria: patients younger than 13 years including neonates who required circumcision for various indications.
Exclusion criteria: - patients with bleeding or clotting disorders
- Those whose parents insisted on a particular type of surgery
- Children with lateral- lateral diameter of the glans over which a Plastibell device could not be placed Primary endpoint: parental concerns and satisfaction (questionnaire) Secondary endpoints: composite morbidity, operative time, postoperative pain (analgesic requirements)
- Early postoperative problems: infection, bleeding, swelling, dysuria, pain (incidence, mean duration, emergency care if necessary, parental concerns about them (on a Likert-type 5-point scale [ not at all, a little, rather, very, very much])
- Irregular scar, jumbling of tissues at the site of frenulum (assessed by physician)
- Postoperative adhesions (assessed by physician)
- Postoperative pain and analgesic requirements (paracetamol 15 mg/kg PO Q6 hrs for 48 hrs then PRN) number of doses and days required for analgesia as judged by parents, VAS ( >- 6 SCORE ), Kaplan-Meier analysis (time to event)
- Parental satisfaction ( overall esthetic outcome [ very much satisfied, very satisfied, rather, a little satisfied, not at all satisfied])
- Parental satisfaction ( skin removal): excess skin removal, insufficient skin removal [ not at all, a little, rather, very, very much]
- Time for bell separation (mean +-SD), Kaplan-Meier analysis for different age groups
详细描述
Outcome of circumcision with Plastibell or conventional dissection techniques in infants and children: A prospective randomized controlled trial Aim: to evaluate and compare postoperative and esthetic outcomes after Plastibell and conventional dissection circumcision
Methods:
A balanced, parallel group, prospective randomized controlled trial is to be performed over 2 years at our institute. Patients enrollment will commence after approval of our institutional review board as well as obtaining informed consent from the patient's legal guardians.
Participants Inclusion criteria: Patients younger than 13 years including neonates who required circumcision for various indications.
Exclusion criteria: - Patients with bleeding or clotting disorders
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 12 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients 3 months - 12 years (inclusive) who required circumcision for various indications.
排除标准
- •Patients with bleeding or clotting disorders
- •Those whose parents insisted on a particular type of surgery
- •Children with lateral- lateral diameter of the glans over which a Plastibell device could not be placed
结局指标
主要结局
Questionnaire for Parental satisfaction (overal esthetic outcome)
时间窗: 3-6 months
- Parental satisfaction ( overall esthetic outcome \[ very much satisfied, very satisfied, rather, a little satisfied, not at all satisfied\])
次要结局
- Early composite morbidity (incidence % and mean duration)(2-4 weeks)
- Likert -type 5-point scale for Parental concerns about early composite morbidity(2-4 weeks)
- Visual Analog Scale (VAS) for Postoperative pain measures(1-2 weeks)
研究者
Dr Abdulrahman Alzahem
Associate professor
King Saud University