Treatment of Thrombosed Haemorrhoids in Pregnancy

Pregnancy Related Clinical Trial

Official title:

Thrombosed External Haemorrhoids During Pregnancy: Surgery Versus Conservative Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04588467
• Other study ID #: 6835447
• Status: Completed
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: October 2, 2020

Study information

• Verified date: October 2020
• Source: Russian Society of Colorectal Surgeons
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2, 2020
• Est. primary completion date: March 2, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Pregnancy

• Thrombosed external haemorrhoids

• Written consent

Exclusion Criteria:

• Inflammatory bowel disease

• Cancer

• Age lower than 18 years old

Related Conditions & MeSH terms

• Haemorrhoidal Crisis
• Hemorrhoids
• Pregnancy Related

Intervention

Other:
• Medical treatment
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

Procedure:
• Surgical treatment
Pregnant women complaining thrombosed haemorrhoids will receive local excision or thrombectomy under local anesthesia

Locations

Country	Name	City	State
Russian Federation	Clinic of Colorectal and Minimally invasive surgery	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Russian Society of Colorectal Surgeons

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain evaluation: scale	A scale of pain will be administered to patients	10 days
Primary	Quality of Life evaluation: questionnaire	A questionnaire of quality of life will be administered to patients after the treatment	10 days