Clinical trial NCT04588467: Treatment of Thrombosed Haemorrhoids in Pregnancy
Official title: Thrombosed External Haemorrhoids During Pregnancy: Surgery Versus Conservative Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Haemorrhoidal Crisis
Pregnancy Related
Lead sponsor: Russian Society of Colorectal Surgeons
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Pregnancy
* Thrombosed external haemorrhoids
* Written consent

Exclusion Criteria:

* Inflammatory bowel disease
* Cancer
* Age lower than 18 years old

Primary outcomes:
measure: Pain evaluation: scale
timeFrame: 10 days
measure: Quality of Life evaluation: questionnaire
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Clinic of Colorectal and Minimally invasive surgery
Study officials:
affiliation: Russian Society of Colorectal Surgeons
name: Inna Tulina, Prof
role: STUDY_DIRECTOR
References: