Surgical Excision Versus Medical Treatment in Acute External Thrombosed Hemorrhoidal Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Pain score with visual analog scale
研究概览
简要总结
Acute external thrombosed hemorrhoidal disease (AETHH) is one of the emergent complications of hemorrhoidal disease that results in pain and loss of work force. Although surgical excision is recommended in the treatment of AETHH in the guidelines of the American Society of Colorectal Surgeons (ASCRS) and the European Society of Coloproctology (ESCP), the level of evidence is low and it is emphasized that additional studies are needed. Therefore, the investigators aimed to compare the efficacy of surgical excision with medical treatment in the treatment of AETHH.
详细描述
Hemorrhoids are normal anatomical structures and are divided into internal and external according to the dentate line. External hemorrhoids distal to the dentate line, unlike internal hemorrhoids, are covered with squamous epithelium (anoderm), have somatic innervation, and are highly sensitive to pain.
While internal hemorrhoidal disease causes symptoms such as painless bleeding, mucosal prolapse, soiling, and itching, external hemorrhoids do not cause clinical findings unless thrombosed. Acute constipation or excessive straining are held responsible for acute external thrombosed hemorrhoidal disease (AETHD). It appears as a painful, firm, purple-colored mass in the anoderm, and the main symptom is anal pain. The severity of pain increases in the first 24-48 hours after the formation of the thrombosed pack and reaches its peak. The pain is quite severe in the first 72-96 hours. Afterwards, with the resorption of the thrombosis, the severity of the pain decreases and the disease heals, leaving a skin tag behind.
AETHD can be treated with surgical excision or conservative approaches. Conservative treatment includes a warm water sitz bath, analgesics, anti-inflammatory drugs. Also, phlebotonic drugs can be added. In the ASCRS and ESCP guidelines, early surgical excision is recommended for patients with acute external thrombosed hemorrhoidal disease in the first 72-96 hours (low quality evidence 2C). Guidelines highlight the lack of controlled studies of AETHD treatment .
In this study, the investigators aimed to compare early surgical excision with conservative treatment in terms of pain control and recurrence in the treatment of AETHD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages of 18-70 who present with isolated external thrombosed hemorrhoids
- •Patients with the onset of the complaint before 96 hours
排除标准
- •Patients under the age of 18 and patients over the age of 70
- •Mentally retarded patients
- •Pregnant patients
- •Patients with concomitant proctological disorders (anal fissure, anal fistula, anal abscess, etc.)
- •Those with a history of proctology surgery
- •Patients with grade 3-4 internal hemorrhoids
- •Patients using anticoagulant drugs
- •Patients whose complaint has passed 96 hours after onset
结局指标
主要结局
Pain score with visual analog scale
时间窗: 12 hours
The participants pain at the 12th hour postoperatively was scored with a visual analog scale. The visual analog scale was between 0 and 10 mm. 0 rated as no pain, 10 as very severe pain.
次要结局
- Recurrence(6 months)
- Satisfaction survey(6 months)
- Time to return to daily activities(15 days)
研究者
Alpaslan Şahin
Principle Investigator
Konya Meram State Hospital
