Treatment of Thrombosed Haemorrhoids in Pregnancy

• ClinicalTrials.gov Identifier: NCT04588467
• Recruitment Status: Completed
• First Posted: October 19, 2020
• Last Update Posted: October 19, 2020
• Sponsor: Russian Society of Colorectal Surgeons
• Information provided by (Responsible Party): Russian Society of Colorectal Surgeons

Study Description

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

Condition or disease	Intervention/treatment	Phase
Haemorrhoidal Crisis; Pregnancy Related	Other: Medical treatment; Procedure: Surgical treatment	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Thrombosed External Haemorrhoids During Pregnancy: Surgery Versus Conservative Treatment
• Actual Study Start Date: January 2, 2019
• Actual Primary Completion Date: March 2, 2020
• Actual Study Completion Date: October 2, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Pregnancy
• Thrombosed external haemorrhoids
• Written consent

Exclusion Criteria:

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

Contacts and Locations

Locations

Russian Federation

Clinic of Colorectal and Minimally invasive surgery

Moscow, Russian Federation, 119435

Sponsors and Collaborators

Russian Society of Colorectal Surgeons

Investigators

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

More Information

• Responsible Party: Russian Society of Colorectal Surgeons
• ClinicalTrials.gov Identifier: NCT04588467
• Other Study ID Numbers: 6835447
• First Posted: October 19, 2020
• Last Update Posted: October 19, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hemorrhoids; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases