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临床试验/NCT05339828
NCT05339828已完成不适用

Unroofing Curettage for Treating Simple and Complex Sacrococcygeal Pilonidal Disease

Ankara Diskapi Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2022年4月27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
203
试验地点
1
主要终点
Recurrence

研究概览

简要总结

This study aimed to investigate the outcomes of patients who underwent UC as the primary intervention for simple or complex SPD

详细描述

Sacrococcygeal pilonidal disease (SPD) is a well-known chronic inflammatory condition that affects young adults; There are many treatment options available today, from simple non-surgical methods to extensive flap procedures. However, elaborate treatment strategies can turn this easily treatable disease into a long-term surgical ordeal, causing complications worse than the primary disease itself.

While, UC is considered safe and effective for treating simple SPD, its suitability for treating complex disease is poor and controversial. To date, no studies have investigated the efficacy of UC specifically when treating complex SPD.

This is the first study to identify and compare efficacy and outcomes after UC in patients classified into simple and complex SPD groups.

This study was conducted at the Department of Surgery of the Diskapi Training and Research Hospital in Ankara, Turkey. The local ethics committee of the institution approved the study protocol (number 27/02, dated March 22, 2016), and written informed consent was obtained from all participants.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Consecutive patients aged 18 years or older

排除标准

  • •acute pilonidal abscess
  • •poorly controlled
  • •diabetes mellitus,
  • •immunosuppressive or coagulation disorders,
  • •pregnancy and/or lactation,
  • •other acute surgical diseases

结局指标

主要结局

Recurrence

时间窗: 15 days

After healing was complete, any new sinus orifice or discharge from the wound was defined as disease recurrence.

次要结局

  • complete healing time(15 days)
  • time to return to daily activities(15 days)
  • VAS pain score(15 days)

研究者

发起方
Ankara Diskapi Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alpaslan Şahin

Principal Investigator

Diskapi Yildirim Beyazit Education and Research Hospital

研究点 (1)

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