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临床试验/NCT04798443
NCT04798443已完成不适用

Comparison of Subureteral Endoscopic Injection of Dextranomer/Hyaluronic Acid and Lich-Gregoir Ureteral Reimplantation In the Treatment of Pediatric Primary Vesicoureteral Reflux: Prospective Randomized Study

Elsayed Salih0 个研究点目标入组 60 人开始时间: 2015年6月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
主要终点
surgical success

研究概览

简要总结

In this study, the investigators aim to compare the outcomes of Dextranomer/hyaluronic acid (Dexell®) and extravesical reimplantation (Lich- Gregoir) procedures for primary vesicoureteral reflux (VUR) grades III and IV in children.

详细描述

A total of 60 patients with 93 renal unites were prospectively enrolled in a comparative intervention study. Patients were randomly allocated by simple randomization at a 1: 1 ratio into 2 groups, where dextranomer/hyaluronic acid (Dexell) injection was used in Group A (30 patients with 45 renal units) and Lich-Gregoir in Group B (30 patients with 48 renal units).

Children over 1 year with primary VUR grade III & IV based on recent VCUG included in the study.

This study and method of attaining consent were approved by clinical research and ethical committee of our department. Written consents were taken from patients' guardians involved in the study. the investigators offered all of patients with symptomatic VUR entry into a prospective protocol between June 2015 and February 2018 at the Urology Department, Al Hussein University Hospital, Al-Azhar University.

Surgical Technique:

  1. dextranomer/hyaluronic acid injection: The endoscopic procedure was done under general anesthesia, and all patients received antibiotic prophylaxis. the investigators used the subureteral injection technique (STING), as described by O'Donnell and Puri . The volume of dextranomer/hyaluronic acid was injected until ureteral orifice collapse in all patients. The needle was held for 30 s.
  2. ureteral reimplantation (lich-gregoir): The juxtavesical ureter is dissected and a submucosal groove is created extending laterally from the ureteral hiatus along the course of the ureter. The ureter is placed in the groove and the detrusor is closed over the ureter with ureteric stent fixation for 21 days. Urethral catheter for bladder drainage for 3-5 days.

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
1 Year 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children over one year with primary Vesico-Ureteral reflux grade III and IV.

排除标准

  • Secondary Vesico-Ureteral reflux.
  • Active urinary tract infection
  • Untreated voiding dysfunction.

结局指标

主要结局

surgical success

时间窗: 2 years

The outcomes between both groups were analyzed according to surgical success rate. The child was considered to have been cured when there was no reflux on VCUG.

次要结局

  • complications(2 years)
  • median costs(2 years)

研究者

发起方
Elsayed Salih
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Elsayed Salih

assistant professor

Al-Azhar University

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