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临床试验/NCT03305523
NCT03305523已完成不适用

The Safety of Thermocautery Usage for Male Children's Circumcisions

Kocatepe University0 个研究点目标入组 1,780 人开始时间: 2014年5月1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
1,780
主要终点
Complication rate

研究概览

简要总结

Since circumcision is a significant workload for surgeons working at the rural state hospitals in Turkey, the use of circumcision techniques that are easy to implement and have low complications is becoming widespread. This research will examine short and long-term complications of male circumcisions using thermocautery technique in light of current literature.

详细描述

Patients who were circumcised between May 2014 and May 2016 at the Pediatric Surgery and Urology Clinics at Yuksekova State Hospital were retrospectively analyzed through the hospital registry system. Patients who underwent circumcision with thermocautery technique were examined in terms of age, duration of circumcision and complication rates. Complications were classified as perioperative (bleeding during the circumcision or under observation at the hospital after circumcision that required knotting or cauterization, scrotum or penile injury), early postoperative (first 10 days after being discharged) and long-term (late postoperative = after 10 days) (skin-mucosal bridge, delayed wound healing, secondary phimosis, meatitis).

Patients were discharged after being kept under observation for 1 hour after circumcision. Patients were suggested to apply routine warm sitting bath, daily dressing and the patients with phimosis opening were suggested to apply epithelizing cream. On the 10th postoperative day, all patients were called for control. Patients who developed complications were included in long-term follow-up. Complications were treated.

Statistical analysis

The data obtained from the study were transferred to a computer environment and evaluated with the help of Statistical Package for Social Sciences Version 19.0. Chi-square test was used to evaluate categorical data and Mann-Whitney U test was used to evaluate quantitative variables. P < 0.05 was considered statistically significant.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
2 Weeks 至 18 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients who circumcised by Thermocautery device Patients without additional disease between 2 weeks and 18 years included in the study Male gender

排除标准

  • Other circumcision Techniques (Conventional surgical, Alis clamp, Tara, Mogen clamp...)
  • Patients older than 18 years
  • The presence of additional diseases ( such as hematologic disease, diabetes...)
  • Patient with hypospadias

结局指标

主要结局

Complication rate

时间窗: perioperative (during circumcision) - 6 months after circumcision

On the 10th postoperative day, all patients were called for control. Patients who developed complications were included in long-term follow-up. Complications were classified as perioperative (bleeding during the circumcision or under observation at the hospital after circumcision that required knotting or cauterization, scrotum or penile injury), early postoperative (first 10 days after being discharged) and long-term complications (10 days- 2 years).

次要结局

  • Surgical processing time(4-15 minutes)

研究者

发起方
Kocatepe University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmet Ali Tuncer

Asst Prof Dr

Kocatepe University

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