Cosmetic Outcomes of Umbilical Hernia Incisions; A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Cosmetic Outcome
研究概览
简要总结
This will be a single institution, prospective, randomized controlled trial. Patients presenting as an outpatient for repair of umbilical hernias who meet our inclusion criteria, whose parents provide permission to participate in the study, will receive the umbilical hernia repair that they are randomized to. The appropriate data will be collected on day of surgery, and patients will be followed with a delayed parental submission of incisional photograph.
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
- None
入排标准
- 年龄范围
- — 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient presenting with umbilical hernia that is <1.5cm in size based on physical exam for outpatient repair
- •Treated at CMH Adele Hall or CMHK from 09/11/24 - 09/11/25
- •Subjects <10 years of age
排除标准
- •Umbilical hernia > 1.5 cm in size
- •Patients with prior umbilical surgery
- •Subjects ≥10 years of age
研究组 & 干预措施
Traditional Infra-umbilical incision
Patients randomized to this arm with have the traditional curvilinear infra-umbilical incision
干预措施: Infra-umbilical incision (Procedure)
Vertical Trans-umbilical Incision
Patients in this arm will have the cranio-caudal vertical incision right through the umbilicus for the repair of the umbilical hernia
干预措施: Transumbilical incision (Procedure)
结局指标
主要结局
Cosmetic Outcome
时间窗: 4 - 6 weeks and 2 years post operation
Cosmetic appearance of incision will be measured using the Pediatric Scar Assessment Questionnaire (PSAQ) filled out by patients and a modified version filled out by an independent assessor .
次要结局
- Operative times(Up to 2 years)
- Surgical site infections(30 days)
- Wound complications(30 days)
- Recurrence(2 years)
研究者
Tolulope Oyetunji
Principal Investigator
Children's Mercy Hospital Kansas City