Haemorrhoidal CrisisNCT04588467
Treatment of Thrombosed Haemorrhoids in Pregnancy
A study testing Medical treatment and Surgical treatment in people with Haemorrhoidal Crisis and Pregnancy Related, run by Russian Society of Colorectal Surgeons at 1 site in Russia.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Haemorrhoidal Crisis, Pregnancy Related
- What is being tested?
- Medical treatment and Surgical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteRussia
- Study dates
- 2 Jan 2019to 2 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnancy
- Thrombosed external haemorrhoids
- Written consent
Who cannot join
- Inflammatory bowel disease
- Cancer
- Age lower than 18 years old
Trial locations and contacts
1 site in 1 country.
Russia1 site
Clinic of Colorectal and Minimally invasive surgery
Moscow, 119435
About this study
Official title: 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
Read the 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.
- Conditions
- Haemorrhoidal Crisis, Pregnancy Related
- Being tested
- Medical treatment, Surgical treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical treatmentOther
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 treatmentProcedure or surgery
Pregnant women complaining thrombosed haemorrhoids will receive local excision or thrombectomy under local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Conservative group | Active comparator | 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 Receives: Other: Medical treatment |
| Surgical group | Experimental | 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 Receives: Procedure: Surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain evaluation: scale
A scale of pain will be administered to patients
Measured: 10 days
Quality of Life evaluation: questionnaire
A questionnaire of quality of life will be administered to patients after the treatment
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start2 Jan 2019
- Primary completion2 Mar 2020
- Study completion2 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Haemorrhoidal CrisisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Russian Society of Colorectal Surgeons
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Inna Tulina, Prof, Study director, Russian Society of Colorectal Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588467
- Sponsor's protocol ID
- 6835447
- Status last verified
- Oct 2020
- First submitted
- 8 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Medkova Y, Tulina I, Novikov I, Nikonov A, Ischenko A, Aleksandrov L, Altomare DF, Dezi A, Picciariello A, Tsarkov P. Thrombosed external hemorrhoids during pregnancy: surgery versus conservative treatment. Updates Surg. 2024 Apr;76(2):539-545. doi: 10.1007/s13304-023-01741-y. Epub 2023 Dec 27.
PubMed 38151682
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombosed External Haemorrhoids During Pregnancy: Surgery Versus Conservative Treatment
- ClinicalTrials.gov ID
- NCT04588467
- Acronym / sponsor ID
- 6835447
- Conditions
- Haemorrhoidal Crisis, Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Russian Society of Colorectal SurgeonsUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 2 Oct 2020 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative group | Active comparator | Other: Medical treatmentConservative 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 | Experimental | Procedure: Surgical treatmentThrombectomy 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnancy
- Thrombosed external haemorrhoids
- Written consent
Key exclusion criteria (3 listed)
- Inflammatory bowel disease
- Cancer
- Age lower than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical treatmentPregnant 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 | Other | Conservative group |
| Surgical treatmentPregnant women complaining thrombosed haemorrhoids will receive local excision or thrombectomy under local anesthesia | Procedure or surgery | Surgical group |
Primary outcome
Pain evaluation: scale
Time frame: 10 days
A scale of pain will be administered to patients
Quality of Life evaluation: questionnaire
Time frame: 10 days
A questionnaire of quality of life will be administered to patients after the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Derived from this study: PubMed 38151682Medkova Y, Tulina I, Novikov I, Nikonov A, Ischenko A, Aleksandrov L, Altomare DF, Dezi A, Picciariello A, Tsarkov P. Thrombosed external hemorrhoids during pregnancy: surgery versus conservative treatment. Updates Surg. 2024 Apr;76(2):539-545. doi: 10.1007/s13304-023-01741-y. Epub 2023 Dec 27.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inna Tulina, Prof study director
Russian Society of Colorectal Surgeons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical treatment and Surgical treatment in people with Haemorrhoidal Crisis and Pregnancy Related, run by Russian Society of Colorectal Surgeons at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain evaluation: scale (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04588467, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.