Skip to main content
OpenTrials
Completed

NCT Number: NCT04588467

Treatment of Thrombosed Haemorrhoids in Pregnancy

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Haemorrhoidal Crisis Pregnancy Related

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinic of Colorectal and Minimally invasive surgery

Moscow, 119435, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnancy
  • Thrombosed external haemorrhoids
  • Written consent

Exclusion criteria

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

Treatment and study plan

Medical treatment

Other

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

surgical treatment

Procedure

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

Primary outcomes

  1. Pain evaluation: scale

    Time frame: 10 days

    A scale of pain will be administered to patients

  2. Quality of Life evaluation: questionnaire

    Time frame: 10 days

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

Sponsors and collaborators

Lead sponsor

Russian Society of Colorectal Surgeons

Other

Registry information

Official study title

Thrombosed External Haemorrhoids During Pregnancy: Surgery Versus Conservative Treatment

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 19, 2020
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.