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临床试验/NCT06527833
NCT06527833已完成不适用

Procedure-Specific Approach To Minimize Fistulaization of The Perianal Abscess Cavity After Surgical Drainage

Suez Canal University2 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2024年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
154
试验地点
2
主要终点
Perianal fistula formation

研究概览

简要总结

Perianal abscess is a common surgical condition primarily caused by infection of rectal and anal glandular crypts due to non-specific obstruction. Around 10% of cases result from various factors like Crohn's disease, trauma, HIV, STDs, radiation therapy, or foreign bodies. Symptoms include perianal pain, back pain, fever, and more. The main treatment is incision and drainage, but packing during drainage can reduce fistula incidence, though it's associated with pain and cost. Research comparing outcomes with and without packing is limited.

详细描述

Perianal abscess is a common anorectal condition. Most perianal abscesses are due to infection of the glandular crypts of the rectum and anus caused by non-specific obstruction. A small percentage of cases, around 10%, can be attributed to alternative causes such as Crohn's disease, trauma, human immunodeficiency virus, sexually transmitted diseases, radiation therapy, or foreign bodies (Nour et al., 2023).

Perianal abscesses are considered one of the most common colorectal pathologies with an estimated annual incidence of around 20,000 people in Egypt (Alkhawaga et al., 2019). Perianal abscess is more common in males as compared to females and more in younger males than older. Also, there is an increased risk of anorectal abscess in conditions such as diabetes, and obesity (Bondurri, 2022) Perianal pain is the most common presentation of perianal abscesses, which may increase with defecation, movement, sitting or coughing. Supra-levator abscesses may present with lower back pain or a dull ache in the pelvic region. Patients may also report fever, malaise, rectal drainage, erythema of surrounding skin and possibly urinary retention (Newton et al., 2022). The severity of pain can sometimes prevent the clinician from performing a digital rectal examination or anoscopic examination, therefore if the diagnosis is in doubt, an examination under general anesthesia should be performed (Pinnell et al., 2021).

Anorectal abscesses can spread into the ischiorectal fossa and can lead to a horse-shoe shaped collection or track up towards and through the levator musculature, which can make the management more challenging. Perianal fistulae are a common complication of peri-anal abscesses. Fistulae can be classified according to their tract location in relation to the internal and external sphincters as transphincteric fistula, high intersphincteric fistula, suprasphincteric fistula or extrasphincteric fistula (Davis & Kasten, 2019).

In the presence of a perianal fistula, imaging modalities such as CT scans are helpful in diagnosing intraabdominal pathology such as Crohn's disease and detecting air within the fistulous tract and the abscess cavity. However, MRI is the investigation of choice in evaluating secondary extensions from the fistulous tract and differentiating it from nearby pelvic soft tissue structures (Sharma et al., 2020).

The management of perianal abscesses is incision and drainage. Without adequately eliminating the source of infection, antibiotics will be ineffective. Minimizing the patient's pain, protecting anal sphincter function and reducing the recurrence of anal fistulae is as important as curing the abscess. Packing at the time of abscess drainage, which requires multiple dressing changes per week for several weeks, can be helpful in providing hemostasis of the inflamed, hypervascular abscess cavity (Sho et al., 2020).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • During the study period, we will include patients above 18 years old with perianal abscesses for the first time.

排除标准

  • Meanwhile patients with sepsis, Previous pelvic radiation., Pregnancy or lactation., Immunosuppressive state, Malignancy, or Refusal to participate will be excluded from this study

结局指标

主要结局

Perianal fistula formation

时间窗: 6 months

To Compare the incidence of fistulous tract formation in patients drained with non-packing vs. packing approach.

Recurrence of perianal abscess

时间窗: 6 months

To Compare the incidence of abscess recurrence formation in patients drained with non-packing vs. packing groups .

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Waleed Ghareeb

Consultant and Lecturer of Surgery

Suez Canal University

研究点 (2)

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