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临床试验/NCT05892198
NCT05892198已完成不适用

A Single Center Experience in the Management of Pilonidal Disease; the Impact of Pits Location on the Choice of the Best Surgical Option.

Mansoura University0 个研究点目标入组 101 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
101
主要终点
Recurrence rate

研究概览

简要总结

Sacrococcygeal pilonidal disease (PND) is a common entity affecting the skin and subcutaneous tissue of the upper portion of the natal cleft of the buttocks. It is characterized by the presence of sinus tracts with recurrent inflammation and infection. It poses a significant healthcare problem due to its related morbidity, impaired quality of life, and financial costs.

详细描述

This acquired disease is caused by negative suction of the hair present in the natal cleft region, leading to a foreign body reaction and subsequent granuloma . It affects 26 per 100000 people, and it mainly affects young men . Surgery for PND is frequently performed in Egypt by general surgeons, with no published data regarding its incidence or prevalence in the Egyptian population.

The PND patient may report different presentations ranging from asymptomatic disease to acute infection and abscess formation. Others may have a chronic disease with recurrent perianal inflammation and discharge.

Multiple surgical options have been described for chronic PND. However, no technique has been universally accepted. The idea of any procedure is to excise the pits with the related sinus tracts leaving healthy tissue as possible to decrease recurrence. The most commonly performed surgical techniques include excision with either primary closure, lay open, or flap-based reconstruction.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Both sexes
  • •aging between 18- 60 years old
  • •who underwent surgical intervention for the pilonidal sinus (Either primary or recurrent)
  • •The surgical intervention includes excision with primary closure or lay open technique, Rhomboid flap and rotational flap.

排除标准

  • •surgically unfit due to commodities.
  • •those who lost follow up

研究组 & 干预措施

primary closure

Active Comparator

The group in which the pits location were in midline ,underwent excision with primary closure

干预措施: surgery (Procedure)

Rhomboid flap group

Active Comparator

in which more lateral pits and pits located <2cm from mid line natal cleft

干预措施: surgery (Procedure)

Rotational flap group

Active Comparator

in which more lateral pits and pits located >2cm from mid line natal cleft

干预措施: surgery (Procedure)

结局指标

主要结局

Recurrence rate

时间窗: 6 months - 1 year

how many cases developed recurrence

Select the best operative technique as regard the number and distribution of the pits in pilonidal sinus cases.

时间窗: 6 months

best surgical option based on pits location

次要结局

  • the incidence of complications such as: wound infection, wound dehiscence, postoperative pain.(1 month)

研究者

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

Ahmad Sakr

Lecturer of general surgery

Mansoura University

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