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临床试验/NCT04588467
NCT04588467已完成不适用

Thrombosed External Haemorrhoids During Pregnancy: Surgery Versus Conservative Treatment

Russian Society of Colorectal Surgeons2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2019年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
2
主要终点
Pain evaluation: scale

研究概览

简要总结

Thrombosis of the external hemorrhoids (TEH) is one of the most frequent complain during pregnancy, particularly during the third trimester.

The paucity of the medical literature on this topic has recently been underlined in the European guidelines for hemorrhoid treatment .

The aim of this prospective study is to compare the efficacy and safety of conservative versus surgical treatment of TEH in pregnant women

详细描述

Thrombosis of external haemorrhoids (TEH) is a quite frequent acute condition that affects women during the pregnancy arousing great concern and impacting quality of life. TEH may present as an acute hemorrhoidal crisis with severe pain and bleeding. Up to 21.8 % of pregnant females complaining of dyschezia present with a thrombosed external haemorrhoid and during last three months, 7.8 % of pregnant females experience a TEH.

Systemic changes in women body can be related to the onset of TEH and even if haemorrhoidal thrombosis does not represent a life-threatening condition during the pregnancy, on the other hand the pain can deteriorate the emotional and physical status arousing worries which affect the health system with high costs due to several accesses to the hospital.

Treatment of TEH is mainly directed to the relief of symptoms, especially pain control. Nowadays conservative and surgical management of TEH during the pregnancy have been demonstrated both effective and safe. Nevertheless, a conservative approach is more accepted as the patient's ability to tolerate the symptoms of her condition would dictate the need for surgery.

In the common practice most patients prefer to be treated conservatively experiencing resolution of their symptoms. On the other hand excision of thrombosed external haemorrhoids results in more rapid symptom resolution, lower incidence of recurrence, and longer remission intervals.

During the pregnancy the administration of conservative medications is quite limited due to the possible side effect of such drugs on the fetus.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnancy
  • Thrombosed external haemorrhoids
  • Written consent

排除标准

  • Inflammatory bowel disease
  • Age lower than 18 years old

结局指标

主要结局

Pain evaluation: scale

时间窗: 10 days

A scale of pain will be administered to patients

Quality of Life evaluation: questionnaire

时间窗: 10 days

A questionnaire of quality of life will be administered to patients after the treatment

次要结局

未报告次要终点

研究者

发起方
Russian Society of Colorectal Surgeons
申办方类型
Other
责任方
Sponsor

研究点 (2)

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