跳至主要内容
临床试验/NCT03415347
NCT03415347Unknown不适用

De-roofing and Curettage Versus Wide Local Excision for the Treatment of Acute Pilonidal Abscess: A Randomised Controlled Trial

London North West Healthcare NHS Trust0 个研究点目标入组 138 人开始时间: 2018年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
138
主要终点
Recurrence of pilonidal abscess

研究概览

简要总结

Pilonidal disease refers to a common disease affecting mostly young males. It may present as asymptomatic pits, acute and painful abscess formation, or chronic discharging sinuses. There are many treatment options for the latter two manifestations but broadly speaking the surgical treatment of acute pilonidal abscess can fall into three categories: (1) incision and drainage, (2) de-roofing and curettage and (3) wide local excision.

The evidence available for the surgical management of acute pilonidal abscess is limited. Previous studies have consistently demonstrated that incision and drainage results in high recurrence rates and should not be considered as the first-line treatment option for the management of acute pilonidal abscess. However, it is not clear whether abscess de-roofing with curettage or wide local excision should be considered as the surgical procedure of choice in acute pilonidal abscess. There has not been a prospective randomised study comparing abscess de-roofing with curettage and wide local excision for acute pilonidal abscess. The ideal surgical procedure would be one that results in the lowest rate of abscess recurrence, treats the underlying pilonidal sinus thereby reducing the need for re-operation but has acceptable post-operative pain, complications and time to complete wound healing.

详细描述

BACKGROUND

Pilonidal disease refers to a common disease affecting mostly young males. It may present as asymptomatic pits, acute and painful abscess formation, or chronic discharging sinuses. There are many treatment options for the latter two manifestations but broadly speaking the surgical treatment of acute pilonidal abscess can fall into three categories: (1) incision and drainage, (2) de-roofing and curettage and (3) wide local excision.

Some authors believe that the incision and drainage method is an effective procedure. However, this method would treat only the acute infection and produce the necessity of re-operation for definite therapy. The alternative method is wide local excision in which the patients receive definite therapy in a single staged operation reducing the number of operations per patient, patient visits to hospital and overall cost to the health service. However, concerns over the length of time to gain acceptable wound healing following wide local excision has decreased its popularity with some surgeons. There is limited evidence available for the surgical management of acute pilonidal abscess which has lead to disagreement as to what is the best option. One randomised study of 76 patients compared incision and drainage of acute pilonidal abscess followed by an elective excision of the pilonidal sinus and primary closure at 3 weeks versus wide local excision with the wound left open for secondary healing. At 12 months the incision and drainage followed by elective excision group had 14% recurrence of pilonidal abscess whereas the wide local excision group had 0% recurrence. Another randomised study of 131 patients compared incision and drainage versus abscess excision (de-roofing) with curettage for acute pilonidal abscess and found recurrence rates of 42% in the incision and drainage group verses 11% in the curettage group. A prospective randomised study similarly compared incision and drainage versus abscess excision (de-roofing) with curettage for acute pilonidal abscess and reported a significantly higher rate of developing a chronic pilonidal sinus in the incision and drainage group (76% vs 24%, p<0.001). A retrospective study with median follow up of 5.3 years has recently been published comparing abscess de-roofing with curettage and wide local excision for acute pilonidal abscess. The authors reported an approximate three-fold increase in recurrence rate in the curettage group compared with the wide local excision group.

RATIONALE FOR CURRENT STUDY

The evidence available for the surgical management of acute pilonidal abscess is limited. Previous studies have consistently demonstrated that incision and drainage results in high recurrence rates and should not be considered as the first-line treatment option for the management of acute pilonidal abscess. However, it is not clear whether abscess de-roofing with curettage or wide local excision should be considered as the surgical procedure of choice in acute pilonidal abscess. There has not been a prospective randomised study comparing abscess de-roofing with curettage and wide local excision for acute pilonidal abscess. The ideal surgical procedure would be one that results in the lowest rate of abscess recurrence, treats the underlying pilonidal sinus thereby reducing the need for re-operation but has acceptable post-operative pain, complications and time to complete wound healing.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients with acute pilonidal abscess

排除标准

  • Patients under the age of 16 years will be excluded.
  • Immunocompromised (diabetes mellitus, taking oral steroids or immunosuppressive medication) patients will be excluded.

研究组 & 干预措施

Abscess de-roofing and curettage

Active Comparator

Abscess de-roofing and curettage. The patient will be placed in the lateral position with the buttocks spread apart using tape. The cleft of the buttocks will be shaved prior to cleaning and preparation of the skin. A spindle-shaped (elliptical) excision will be performed to the lateral aspect of the abscess formation with a scalpel staying away from the midline. Once the pus has been drained through this lateral incision the wound cavity will then be curetted and washed out with hydrogen peroxide. The wound size will be measured by the operating surgeon who will record the maximal length and width of the wound. Once haemostasis (cessation of any bleeding) is achieved the wound will be packed with Kaltostat ribbon and the wound dressed with blue gauze and mefix tape. The wound is therefore left open.

干预措施: Abscess de-roofing and curettage (Procedure)

Abscess wide local excision

Active Comparator

Wide local excision. Patients will be placed in the prone position with the buttocks spread apart using tape. The cleft of the buttocks will be shaved prior to cleaning and preparation of the skin. Diluted methylene blue will be injected in all visible pits and a wide spindle-shaped (elliptical) midline excision of the skin and the underlying subcutaneous tissue down to the coccygeal (pre-sacral) fascia including all sinuses will be performed with electrocautery. The specimen will be sent for histology as per routine surgical practice. The wound will be washed with hydrogen peroxide. The wound size will be measured by the operating surgeon who will record the maximal length and width of the wound. Once haemostasis (cessation of any bleeding) is achieved the wound will be packed with Kaltostat ribbon and the wound dressed with blue gauze and mefix tape. The wound is therefore left open.

干预措施: Abscess wide local excision (Procedure)

结局指标

主要结局

Recurrence of pilonidal abscess

时间窗: 1 year

During the follow up period the primary outcome measure will be if the patient develops a (recurrent) pilonidal abscess. This is a clinical diagnosis made by the clinician (General Practitioner or Hospital Doctor) attending to the patient. The definition for recurrent pilonidal abscess is any pilonidal abscess that occurs requiring either antibiotic (oral or intravenous) or surgical treatment. A small amount of discharge that settles on its own without the need for such treatment will not be counted as a recurrence.

次要结局

  • Procedural time(1 hour)
  • Wound size at operation(1 hour)
  • Time to complete wound healing(4-10 weeks)
  • Return to work(2-8 weeks)
  • Wound size over time(4-10 weeks)
  • Post-operative pain scores(4-10 weeks)
  • Patient wound impact questionnaire(4-10 weeks)
  • Wound infection rate(4-10 weeks)

研究者

申办方类型
Other
责任方
Sponsor

相似试验