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临床试验/NCT02277340
NCT02277340已完成1 期

Endoscopic Treatment of Pilonidal Sinus May Decrease the Recurrence After Crystallized Phenol Application

Ankara University0 个研究点目标入组 23 人开始时间: 2014年2月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
23
主要终点
Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application

研究概览

简要总结

This study presents 23 sacrococcygeal pilonidal disease cases treated with endoscopic cleaning and fulguration of pilonidal sinus inner surfaca followed by application of crystallized phenol into the sinus.

详细描述

Endoscopic treatment and crytallized phenol application are two sovereign treatments described for pilonidal disease. The curative rate may be as low as 65 % and the recurrence rate is at least 10 % after crystallized phenol alone application for pilonidal disease. The experience with endoscopic treatment of pilonidal sinus is only limited but at least 4 % recurrence rate was reported.

In this study a preliminary group of 23 patients were treated with combination of these two modalities between February to May 2014 and at the end of 6-9 months follow up, there was no recurrence after excellent cosmetic results. Patients were all operated and mild sedation and local anesthesia. There was no serious complication but only some skin irritation was noticed secondary to phenol burn. Some patients felt mild pain and the pain was self limited in most cases where only a few needed oral pain killers. Some patients were observed to have mild drainage from the sinus but only two of them needed further application of phenol crystals.

研究设计

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

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with pilonidal disease with no acute abscess

排除标准

  • •Patients with aacute pilonidal disease abscess

研究组 & 干预措施

EAPA for Pilonidal Disease

Experimental

The abbrevition EAPA is used to describe the study. The cohort of pilonidal disease patients treated who do not have an acute abscess or other problems like hydradenitis suppurativa, has been treated by endoscopy assisted fulguration of the inner surface and additional crystallized phenol application for further clean up of the remaining tissue as well as preventing bacterial growth.

干预措施: EAPA (Procedure)

结局指标

主要结局

Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application

时间窗: six months

"Number of Participants with Adverse Events as a Measure of Safety and Tolerability".

次要结局

  • Endoscopic Pilonidal Sinus Treatment With Additional Crystalized Phenol Application(six months)

研究者

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

I Ethem Gecim

Prof Dr

Ankara University

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