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临床试验/NCT06009133
NCT06009133已完成不适用

Surgical Excision Versus Medical Treatment in Acute External Thrombosed Hemorrhoidal Disease

Konya Meram State Hospital1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2022年7月1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
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

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

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

Alpaslan Şahin

Principle Investigator

Konya Meram State Hospital

研究点 (1)

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