Conservative Versus Surgical Treatment of Umbilical Pilonidal Sinus Disease: A Prospective, Randomised, and Multicenter Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 10
- 主要终点
- Cure Rate
研究概览
简要总结
The aim of the study was to compare the results of conservative and surgical treatment, to create an algorithm for the management of the disease, and gain more information about the etiology, pathogenesis, and course of the disease. The investigators hypothesise that surgical treatment of UPS will be better than conservative management in terms of recurrence rate, healing time, patient comfort and satisfaction, and cost effectiveness.
详细描述
Because of its rarity, umbilical pilonidal sinus (UPS) is still poorly understood in terms of diagnosis, etiology, and the best treatment options.
UPS is thought caused by hair penetrating the skin, leading to a foreign-body reaction and development of a sinus lined with granulation tissue. Most of the patients complain of pain, discharge or bleeding from the umbilicus when symptoms develop. It can be diagnosed with a careful examination, in which hairs can be seen deep in the umbilicus and usually protrude from a small sinus.
Regarding the optimal treatment of the disease, a complete consensus has not yet been achieved. Some publications are recommended conservative treatment, while surgical treatment is recommended in others.
A more meaningful comparison of the two modalities is that of a randomized controlled trial. We, therefore, present our data of prospective randomized controlled clinical trial comparing conservative versus surgical treatment of UPS.
This was a multicenter, prospective balanced randomization, double blind, active-controlled, parallel-group, superiority study conducted in Turkey, under the direction of a principal investigator (MK). Eligible patients with UPS were randomized for either conservative treatment (CT) or surgical treatment (ST), and then the results of both groups were compared.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients willing to participate to the study with the diagnosis of umbilical pilonidal sinus
排除标准
- •no informed consent
- •serious coagulation abnormalities
- •known allergy to local anesthetics
- •pregnancy, or women who refused contraception at the time of treatment
- •other concomitant umbilical pathologies such as umbilical hernia, granuloma, dermoid cyst
- •the patients who diagnosed with urachal and omphalomesenteric anomalies through radiological investigation
- •patients who underwent umbilical operation
结局指标
主要结局
Cure Rate
时间窗: 2 year after initial treatment
Primary outcome was the cure rate. Absence of recurrence within two year after the first treatment was considered as a cure. Recurrence was defined as the appearance of a new, active discharging sinus or granulation tissue with/without a bit of hairs in the deep of the umbilicus within two years after therapy.
次要结局
- Healing Time(two year)
- Visual Analogue Scale for Patient Satisfaction (VAS-PS)(30 days)
研究者
Mehmet Kaplan
Principal investigator
Medical Park Gaziantep Hospital