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Treatment of Thrombosed Haemorrhoids in Pregnancy

Thrombosed External Haemorrhoids During Pregnancy: Surgery Versus Conservative Treatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04588467
Enrollment
35
Registered
2020-10-19
Start date
2019-01-02
Completion date
2020-10-02
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemorrhoidal Crisis, Pregnancy Related

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.

Interventions

OTHERMedical 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

PROCEDURESurgical treatment

Pregnant women complaining thrombosed haemorrhoids will receive local excision or thrombectomy under local anesthesia

Sponsors

Russian Society of Colorectal Surgeons
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Pregnancy * Thrombosed external haemorrhoids * Written consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Pain evaluation: scale10 daysA scale of pain will be administered to patients
Quality of Life evaluation: questionnaire10 daysA questionnaire of quality of life will be administered to patients after the treatment

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026