跳至主要内容
临床试验/NCT05297916
NCT05297916Unknown4 期

Early Versus Delayed Postoperative Enteral Feeding to Reduce the Incidence of Perineal Wound Infection Following Anterior Sagittal Anorectoplasty of Congenital Recto-vestibular Fistula

Tanta University2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2022年2月2日最近更新:
适应症

试验速览

阶段
4 期
入组人数
55
试验地点
2
主要终点
perineal wound infection

研究概览

简要总结

to study the effect of early vs delayed enteral feeding following ASARP in females with congenital recto-vestibular fistula

详细描述

congenital Recto vestibular fistula represents the commonest type of anorectal malformation in females. The treatment of this anomaly is mainly approached either through anterior or posterior sagittal ano-rectoplasty approach. Several perioperative factors may affect the outcome. One of major postoperative complications is the occurrence of wound infection.

Purpose: we aimed to study the effect of delayed vs early postoperative enteral feeding on the occurrence of postoperative wound infection and dehiscence.

Patients and methods:

A prospective randomized trial included 55 infants with recto-vestibular fistula. All infants were managed by single stage anterior sagittal anorectoplasty at an age ≥ 3 months. Patients were divided into two groups. group A included infants who started oral intake on the 5th postoperative day and group B included infants who started oral intake on the 2nd postoperative day. The primary outcome was the onset of perineal wound infection. Group A infants were kept on peripheral parenteral nutrition during fasting period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

接受健康志愿者

入选标准

  • All female infants with congenital rectoperineal fistula

排除标准

  • patients with major anomalies, patients who have staged repair

结局指标

主要结局

perineal wound infection

时间窗: WITHIN TWO WEEKS POST OPERATIVE

the occurrence of wound infection after ASARP

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammad Gharieb Mohammad Khirallah

assistant professor of pediatric surgery

Tanta University

研究点 (2)

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