Treatment of Thrombosed Haemorrhoids in Pregnancy

Thrombosed External Haemorrhoids During Pregnancy: Surgery Versus Conservative Treatment

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

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Haemorrhoidal Crisis
• Intervention / Treatment: Other: Medical treatment; Procedure: Surgical treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119435
    • Clinic of Colorectal and Minimally Invasive Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pregnancy
• Thrombosed external haemorrhoids
• Written consent

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conservative group; Conservative treatment included dietary modification (intake of at lest 3 liters 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 (Lidocaine 2.5%+Prilocaine 2.5%, 2g twice a day) for 10 days	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
Experimental: Surgical group; Thrombectomy and local excision of external hemorrhoids were performed with the patient in the lithotomy position under local infiltrative anesthesia with UltracainDS 1:200000 1.7ml	Procedure: Surgical treatment; Pregnant women complaining thrombosed haemorrhoids will receive local excision or thrombectomy under local anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain evaluation: scale	A scale of pain will be administered to patients	10 days
Quality of Life evaluation: questionnaire	A questionnaire of quality of life will be administered to patients after the treatment	10 days

Collaborators and Investigators

• Sponsor: Russian Society of Colorectal Surgeons
• Investigators: Study Director: Inna Tulina, Prof, Russian Society of Colorectal Surgeons

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Actual): March 2, 2020
• Study Completion (Actual): October 2, 2020

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: October 14, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 14, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: 6835447

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No