Multicenter Randomized Controlled Trial of Mobilized Gluteus Maximus Muscle Fascia Flap Versus Primary Closure in the Treatment of Primary and Recurrent Pilonidal Sinus Disease.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Recurrence rate
研究概览
简要总结
Surgical treatment is still gold standard for pilonidal sinus disease. Several surgical techniques have been proposed to treat this disease in the last two decades. A new method - midline excision of pilonidal sinus and wound closure using gluteus maximus fascia plasty flap (GMFF) - was proposed recently as a new method of treatment that results in low reccurence rate and good cosmetic results.
The aim of this study is to compare a new method (GMFF) with a traditional method (midline excision and primary closure) in terms of recurrence rate, complications and patient satisfaction with results.
详细描述
Pilonidal sinus disease (PSD) is a rather rare benign condition (about 26 cases per 100,000 population) that affects primarily young adults. Because of purulent nature it is treated with surgery only.
Traditional surgical techniques encompass midline excision of the purulent cyst and either leaving the wound "lay open" for secondary closure or midline primary closure. The latter method has a major drawback of high recurrence rate and very long healing and patient disability periods. Therefore alternative techniques to close the wound after pilonidal sinus excision were proposed. In some a muscular-cutaneous flaps are created and the wound is closed in a Z- or Y- or other shape manner. The recurrence rate of these techniques is significantly lower than with a traditional midline closure, but healing time and final cosmetic results are far from ideal in patient view.
Recently a new method of wound closure was developed independently by a few groups that includes bilateral mobilisation of gluteus maximus muscles fascia and midline closure of the wound. Preliminary results demonstrated that this method leads to lower recurrence rate and better cosmetic results because the natal cleft is saved.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Chronic primary or recurrent pilonidal sinus at the remission stage.
- •Presence or absence of secondary orifices.
- •Planned surgical treatment with excision of pilonidal sinus.
- •Location of secondary orifices less than 2 cm from the natal cleft.
- •The distance between bilateral symmetrical secondary orifices less than 2 cm.
- •American Society Anesthesiologists (ASA) score 1 to 3
- •Non-inclusion Criteria:
- •Acute pilonidal sinus abscess.
- •The secondary openings (orifice) position more than 2 cm from the midline.
- •Predictable impossibility of following the protocol.
排除标准
- •1 The patients lost for the further observation.
- •The patient's refusal to continue participate in the investigation.
研究组 & 干预措施
Primary Closure
After pilonidal sinus is excised, subcutaneous fat and skin are closed in midline with a running suture
干预措施: Primary Closure (Procedure)
Gluteus Maximus Plasty Flap
After pilonidal sinus is excised, gluteus maximus fascia flaps will be mobilised, approximated in the midline and fixed with a running suture. Subcutaneous fat and skin are closed in midline with a running suture.
干预措施: Gluteus Maximus Fascia Plasty Flap (Procedure)
结局指标
主要结局
Recurrence rate
时间窗: starting from 6 months after surgery and up to 5 years after surgery
The rate of disease recurrence (clinical picture of pilonidal sinus and/or appearance of new openings in the intergluteal cleft and/or chronic unhealing wound and/or residual cavity in the wound area as confirmed by the soft tissue ultrasound)
次要结局
- Operative time(1 day)
- Postoperative pain intensity - late postoperative period(On 10th, 14th, 21st, 30 day after surgery)
- Overall quality of life(1-7 days before surgery, 1 month, 3 months, 1 year, 3 years, 5 years after surgery)
- Bloodloss(1 day)
- Wound seroma rate(90 days after surgery)
- Wound healing rate(6 months after surgery)
- Postoperative pain intensity - early postoperative period(On 1st, 3rd, 5th and 7th postoperative day)
- Surgical site infection rate(3 month after surgery)
- Inhospital stay(30 days)
- Wound hemorrhage rate(Within 30 days from surgery)
- Wound healing speed(5 years after surgery)
- Secondary surgery rate(5 years)
- Patient satisfaction with cosmetic results(6 months, 1 year, 3 years, 5 years after surgery)