Treatment of Thrombosed Haemorrhoids in Pregnancy
Condition: Haemorrhoidal Crisis; Pregnancy Related
MeSH terms: Hemorrhoids
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      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.

      The aim of this prospective study is to evaluate and compare the efficacy and safety of
      conservative and surgical treatment in patients affected by TEH during pregnancy. With regard
      to surgical management, thrombectomy and local excision of external haemorrhoids were
      compared.
    

Intervention name(s): Medical treatment; Surgical treatment
Intervention type(s): Other; Procedure
Intervention description(s): Pregnant women complaining thrombosed haemorrhoids will receive dietary modification (intake of at lest 3 liers of water), stool-softeners (a 25 ml solution containing: Macrogol 3350: 13.125 g Sodium chloride: 0.3508 g Sodium hydrogen carbonate: 0.1786 g Potassium chloride: 0.0502 g) and local anesthetics application; Pregnant women complaining thrombosed haemorrhoids will receive local excision or thrombectomy under local anesthesia
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment