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临床试验/NCT05851690
NCT05851690已完成不适用

Bilaterally Parallel Elliptic Flap Versus Karydakis Flap in Pilonidal Sinus Disease: A Randomized Controlled Trial

Atlas University0 个研究点目标入组 102 人开始时间: 2016年6月16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
102
主要终点
Postoperative pain

研究概览

简要总结

Sacrococcygeal pilonidal sinus disease (PSD) has been defined as a disease characterized by chronic inflammation and recurrent infections caused by the movement of hair toward the gluteal sulcus. This condition is especially seen in young men and negatively affects the quality of life of patients and prevents them from performing their work and school activities. The treatment options for PSD range from the use of antibiotics alone to reconstructed excision with tissue flaps. Although the optimal surgical treatment option remains controversial, expectations from the ideal surgical treatment include low recurrence and postoperative complication rates, early wound healing, short hospital stay, early return to work, and good cosmetic outcomes. The aim of this study was to compare the efficacy of the different flap techniques in the surgical treatment of PSD and evaluate the long-term outcomes of patients.

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

性别
All
接受健康志愿者

入选标准

  • Underwent surgery due to pilonidal sinus disease

排除标准

  • Patients with a history of previous pilonidal sinus surgery,
  • An acute pilonidal abscess,
  • immunodeficiency,
  • using immunosuppressive drugs,
  • refuse to participate in the study

结局指标

主要结局

Postoperative pain

时间窗: 1 day

The pain scores of the patients were determined on the first postoperative day. The Visual Analog Scale (VAS), scored from 1 to 10, was administered to the patients to evaluate their postoperative pain levels.

Time taken to return to work/school

时间窗: The patients' return to work ranged from 11 to 49 days.

Time to return to work in daily life after surgery

次要结局

  • Length of hospital stay(The patients' length of hospital stay ranged from 1 to 4 days.)
  • Recurrence of the disease(43 months)

研究者

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

Umut Fırat Turan

Asst. Prof.

Atlas University

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