Treatment of Thrombosed Haemorrhoids in Pregnancy
Primary Purpose
Haemorrhoidal Crisis, Pregnancy Related
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Medical treatment
Surgical treatment
Sponsored by
About this trial
This is an interventional treatment trial for Haemorrhoidal Crisis
Eligibility Criteria
Inclusion Criteria:
- Pregnancy
- Thrombosed external haemorrhoids
- Written consent
Exclusion Criteria:
- Inflammatory bowel disease
- Cancer
- Age lower than 18 years old
Sites / Locations
- Clinic of Colorectal and Minimally invasive surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conservative group
Surgical group
Arm Description
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
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
Outcomes
Primary Outcome Measures
Pain evaluation: scale
A scale of pain will be administered to patients
Quality of Life evaluation: questionnaire
A questionnaire of quality of life will be administered to patients after the treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT04588467
First Posted
October 8, 2020
Last Updated
October 14, 2020
Sponsor
Russian Society of Colorectal Surgeons
1. Study Identification
Unique Protocol Identification Number
NCT04588467
Brief Title
Treatment of Thrombosed Haemorrhoids in Pregnancy
Official Title
Thrombosed External Haemorrhoids During Pregnancy: Surgery Versus Conservative Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
March 2, 2020 (Actual)
Study Completion Date
October 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Russian Society of Colorectal Surgeons
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemorrhoidal Crisis, Pregnancy Related
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conservative group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Surgical group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Medical treatment
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Surgical treatment
Intervention Description
Pregnant women complaining thrombosed haemorrhoids will receive local excision or thrombectomy under local anesthesia
Primary Outcome Measure Information:
Title
Pain evaluation: scale
Description
A scale of pain will be administered to patients
Time Frame
10 days
Title
Quality of Life evaluation: questionnaire
Description
A questionnaire of quality of life will be administered to patients after the treatment
Time Frame
10 days
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnancy
Thrombosed external haemorrhoids
Written consent
Exclusion Criteria:
Inflammatory bowel disease
Cancer
Age lower than 18 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inna Tulina, Prof
Organizational Affiliation
Russian Society of Colorectal Surgeons
Official's Role
Study Director
Facility Information:
Facility Name
Clinic of Colorectal and Minimally invasive surgery
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Thrombosed Haemorrhoids in Pregnancy
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