跳至主要内容
临床试验/NCT05289297
NCT05289297招募中不适用

Karydakis Flap Procedure Versus Burow's Triangle Advancement Flap Procedure in the Surgical Treatment of Sacrococcygeal Pilonidal Sinus Disease

Istanbul Sultanbeyli State Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
2
主要终点
Pain score according to the visual analogue scale

研究概览

简要总结

In this study, we aim to compare the Karydakis flap and Burow's Triangle Advancement Flap techniques applied in the surgical treatment of pilonidal sinus in terms of complications, time to return to normal activity, and recurrence.

详细描述

Pilonidal sinus disease (PSD) is a chronic and inflammatory disease that is often generated in the sacrococcygeal region. It is commonly observed in puberty and young adult period and usually affects men. The incidence of pilonidal sinus disease is 26:100,000 and rising globally.

PSD risk factors contain young age, obesity, male gender, Mediterranean ethnicity, deep natal cleft, hairiness, and poor hygiene. It has been shown that PSD incidence increases in parallel with body weight. The precise etiology of pilonidal sinus disease is unclear. Many conservative and surgical methods have been described in treating pilonidal sinus disease. After the sinus area is excised, excision with laying open (secondary healing), excision with primary closure, marsupialization, and various flap techniques can be applied in surgical treatment. The primary principle in treatment is to ensure that the patient returns to normal life as soon as possible and eliminate recurrences. Although the best surgical technique in treating pilonidal sinus is controversial, the ideal operation should be cost-effective, simple to perform, short hospital stay, and have a low recurrence and complication rates. There is no definite consensus on an ideal technique yet.

In this study, we aim to compare the Karydakis flap and Burow's Triangle Advancement Flap techniques applied in the surgical treatment of pilonidal sinus in our clinic in terms of complications (wound dehiscence, seroma, hematoma, surgical site infection), time to return to normal activity, and recurrence.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between the ages of 18-65
  • Primary pilonidal sinus disease
  • No abscess and absence of active infection during the operation

排除标准

  • Patients under the age of 18 and over the age of 65
  • Recurrent pilonidal sinus cases
  • Patients with chronic comorbidities such as immunosuppression, collagen tissue disease, insulin-dependent diabetes mellitus, and neurological disease
  • Patients with an ASA score of 3-4
  • Patients with a body mass index greater than 35 kg/m2
  • Patients with drug and alcohol addiction

结局指标

主要结局

Pain score according to the visual analogue scale

时间窗: 1-3 days

Postoperative pain after surgery ( measured by the visual analog score with 1 being minimum score and 10 being maximum score)

Postoperative wound healing time

时间窗: 4 to 6 weeks

Number of weeks of complete duration epithelialization of the wound

Procedure-related complications

时间窗: 1 to 6 weeks

Number of complications; related to the surgery, Type (wound dehiscence, seroma, hematoma, surgical site infection)

Time to return to normal activity

时间窗: 4 to 6 weeks

The number of weeks it passes the patient to return to normal activity.

次要结局

  • Recurrence of Pilonidal Sinus(6 - 12 months)

研究者

发起方
Istanbul Sultanbeyli State Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验