Treatment of Thrombosed Haemorrhoids in Pregnancy

Not Applicable

Completed

• Conditions: Pregnancy Related; Haemorrhoidal Crisis
• Interventions: Other: Medical treatment; Procedure: Surgical treatment

• Registration Number: NCT04588467
• Lead Sponsor: Russian Society of Colorectal Surgeons

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.

Study Timeline

• Study Start: 2019-01-02
• Primary Completion: 2020-03-02
• Status Verified: 2020-10
• Study Completion: 2020-10-02
• Study First Submitted: 2020-10-08
• Study First Submitted QC: 2020-10-14
• Last Update Submitted: 2020-10-14
• Study First Posted: 2020-10-19
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

• Pregnancy
• Thrombosed external haemorrhoids
• Written consent

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conservative group	Medical treatment	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
Surgical group	Surgical treatment	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

Primary Outcome Measures

Name	Time	Method
Pain evaluation: scale	10 days	A scale of pain will be administered to patients
Quality of Life evaluation: questionnaire	10 days	A questionnaire of quality of life will be administered to patients after the treatment

Trial Locations

Locations (1)

Clinic of Colorectal and Minimally invasive surgery; 🇷🇺 Moscow, Russian Federation