Hemorrhoids External ThrombosedNCT06009133
Surgical Approach for Acute External Thrombosed Hemorrhoidal Disease
An observational study of Hemorrhoids External Thrombosed, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Acute external thrombosed hemorrhoidal disease (AETHH) is one of the emergent complications of hemorrhoidal disease that results in pain and loss of work force. Although surgical excision is recommended in the treatment of AETHH in the guidelines of the American Society of Colorectal Surgeons (ASCRS) and the European… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemorrhoids External Thrombosed
- What is being tested?
- Conservative treatment and Surgical Treatment
- Type of treatment
- Surgery or procedure
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 14 Mar 2023
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of the study consisted of patients who applied to the general surgery outpatient clinic due to acute external thrombosed hemorrhoids disease. Patients who fully met the inclusion criteria and did not meet the exclusion criteria constituted the sample group.
Who may be able to join
- Patients between the ages of 18-70 who present with isolated external thrombosed hemorrhoids
- Patients with the onset of the complaint before 96 hours
Who cannot join
- Patients under the age of 18 and patients over the age of 70
- Mentally retarded patients
- Pregnant patients
- Patients with concomitant proctological disorders (anal fissure, anal fistula, anal abscess, etc.)
- Those with a history of proctology surgery
- Patients with grade 3-4 internal hemorrhoids
- Patients using anticoagulant drugs
- Patients whose complaint has passed 96 hours after onset
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Training and Research Hospital
Konya, 42090
About this study
Official title: Surgical Excision Versus Medical Treatment in Acute External Thrombosed Hemorrhoidal Disease
Acute external thrombosed hemorrhoidal disease (AETHH) is one of the emergent complications of hemorrhoidal disease that results in pain and loss of work force. Although surgical excision is recommended in the treatment of AETHH in the guidelines of the American Society of Colorectal Surgeons (ASCRS) and the European Society of Coloproctology (ESCP), the level of evidence is low and it is emphasized that additional studies are needed. Therefore, the investigators aimed to compare the efficacy of surgical excision with medical treatment in the treatment of AETHH.
Read the detailed description
Hemorrhoids are normal anatomical structures and are divided into internal and external according to the dentate line. External hemorrhoids distal to the dentate line, unlike internal hemorrhoids, are covered with squamous epithelium (anoderm), have somatic innervation, and are highly sensitive to pain.
While internal hemorrhoidal disease causes symptoms such as painless bleeding, mucosal prolapse, soiling, and itching, external hemorrhoids do not cause clinical findings unless thrombosed. Acute constipation or excessive straining are held responsible for acute external thrombosed hemorrhoidal disease (AETHD). It appears as a painful, firm, purple-colored mass in the anoderm, and the main symptom is anal pain. The severity of pain increases in the first 24-48 hours after the formation of the thrombosed pack and reaches its peak. The pain is quite severe in the first 72-96 hours. Afterwards, with the resorption of the thrombosis, the severity of the pain decreases and the disease heals, leaving a skin tag behind.
AETHD can be treated with surgical excision or conservative approaches. Conservative treatment includes a warm water sitz bath, analgesics, anti-inflammatory drugs. Also, phlebotonic drugs can be added. In the ASCRS and ESCP guidelines, early surgical excision is recommended for patients with acute external thrombosed hemorrhoidal disease in the first 72-96 hours (low quality evidence 2C). Guidelines highlight the lack of controlled studies of AETHD treatment .
In this study, the investigators aimed to compare early surgical excision with conservative treatment in terms of pain control and recurrence in the treatment of AETHD.
- Conditions
- Hemorrhoids External Thrombosed
- Being tested
- Conservative treatment, Surgical Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative treatmentProcedure or surgery
Micronized purified flavonoid fraction, which is routinely used within indications in hemorrhoidal disease and recommended in ESCP and ASCRS guidelines, and licensed for use in hemorrhoidal disease by the Ministry of Health in our country, was given 2 g/day for one month.
Also, Conservative methods (fiber foods, warm shower, regulation of toilet habits, laxatives and nonsteroidal anti-inflammatory drugs) were recommended.
Surgical TreatmentProcedure or surgery
While the patient was in the Jack-knife position, both hips were pulled laterally with tapes, appropriate visualization was obtained, the external thrombosed pack was excised under local anesthesia, and the wound was left to heal with secondary intention.Conservative methods were recommended in the surgical group as well as in the medical group.
| Study group | Role | What they receive |
|---|---|---|
| Conservative Treatment Group | Micronized purified flavonoid fraction, which is routinely used within indications in hemorrhoidal disease and recommended in ESCP and ASCRS guidelines, and licensed for use in hemorrhoidal disease by the Ministry of Health in our country, was given 2 g/day for one month.
Also, Conservative methods (fiber foods, warm shower, regulation of toilet habits, laxatives and nonsteroidal anti-inflammatory drugs) were recommended. Receives: Procedure: Conservative treatment | |
| Surgical Treatment Group | While the patient was in the Jack-knife position, both hips were pulled laterally with tapes, appropriate visualization was obtained, the external thrombosed pack was excised under local anesthesia, and the wound was left to heal with secondary intention.Conservative methods were recommended in the surgical group as well as in the medical group. Receives: Procedure: Surgical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score with visual analog scale
The participants pain at the 12th hour postoperatively was scored with a visual analog scale. The visual analog scale was between 0 and 10 mm. 0 rated as no pain, 10 as very severe pain.
Measured: 12 hours
Secondary outcomes (3)
Time to return to daily activities
The patients' return to daily activities were recorded.
Measured: 15 days
Recurrence
It was recorded whether the patients had hemorrhoid recurrence at 6 months.
Measured: 6 months
Satisfaction survey
The satisfaction level of the participants was scored on a visual analog scale six months after the treatment. The visual analog scale was between 0 and 10 mm. 0 was rated as not at all satisfied, and 10 was rated as very satisfied.
Satisfaction questionnaire was applied to the patients at 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Jul 2022
- Primary completion31 Dec 2022
- Study completion14 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhoids External ThrombosedStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alpaslan Şahin, Konya Meram State Hospital
- Investigators
- Hasan Yaldız, MD, Principal investigator, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009133
- Sponsor's protocol ID
- Konya HH Group
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Excision Versus Medical Treatment in Acute External Thrombosed Hemorrhoidal Disease
- ClinicalTrials.gov ID
- NCT06009133
- Acronym / sponsor ID
- Konya HH Group
- Conditions
- Hemorrhoids External Thrombosed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 24 Aug 2023 (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.
Acute external thrombosed hemorrhoidal disease (AETHH) is one of the emergent complications of hemorrhoidal disease that results in pain and loss of work force. Although surgical excision is recommended in the treatment of AETHH in the guidelines of the American Society of Colorectal Surgeons (ASCRS) and the European Society of Coloproctology (ESCP), the level of evidence is low and it is emphasized that additional studies are needed. Therefore, the investigators aimed to compare the efficacy of surgical excision with medical treatment in the treatment of AETHH.
Detailed description
Hemorrhoids are normal anatomical structures and are divided into internal and external according to the dentate line. External hemorrhoids distal to the dentate line, unlike internal hemorrhoids, are covered with squamous epithelium (anoderm), have somatic innervation, and are highly sensitive to pain.
While internal hemorrhoidal disease causes symptoms such as painless bleeding, mucosal prolapse, soiling, and itching, external hemorrhoids do not cause clinical findings unless thrombosed. Acute constipation or excessive straining are held responsible for acute external thrombosed hemorrhoidal disease (AETHD). It appears as a painful, firm, purple-colored mass in the anoderm, and the main symptom is anal pain. The severity of pain increases in the first 24-48 hours after the formation of the thrombosed pack and reaches its peak. The pain is quite severe in the first 72-96 hours. Afterwards, with the resorption of the thrombosis, the severity of the pain decreases and the disease heals, leaving a skin tag behind.
AETHD can be treated with surgical excision or conservative approaches. Conservative treatment includes a warm water sitz bath, analgesics, anti-inflammatory drugs. Also, phlebotonic drugs can be added. In the ASCRS and ESCP guidelines, early surgical excision is recommended for patients with acute external thrombosed hemorrhoidal disease in the first 72-96 hours (low quality evidence 2C). Guidelines highlight the lack of controlled studies of AETHD treatment .
In this study, the investigators aimed to compare early surgical excision with conservative treatment in terms of pain control and recurrence in the treatment of AETHD.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative Treatment Group | – | Procedure: Conservative treatmentMicronized purified flavonoid fraction, which is routinely used within indications in hemorrhoidal disease and recommended in ESCP and ASCRS guidelines, and licensed for use in hemorrhoidal disease by the Ministry of Health in our country, was given 2 g/day for one month. Also, Conservative methods (fiber foods, warm shower, regulation of toilet habits, laxatives and nonsteroidal anti-inflammatory drugs) were recommended. |
| Surgical Treatment Group | – | Procedure: Surgical TreatmentWhile the patient was in the Jack-knife position, both hips were pulled laterally with tapes, appropriate visualization was obtained, the external thrombosed pack was excised under local anesthesia, and the wound was left to heal with secondary intention.Conservative methods were recommended in the surgical group as well as in the medical group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of the study consisted of patients who applied to the general surgery outpatient clinic due to acute external thrombosed hemorrhoids disease. Patients who fully met the inclusion criteria and did not meet the exclusion criteria constituted the sample group.
Key inclusion criteria (2 listed)
- Patients between the ages of 18-70 who present with isolated external thrombosed hemorrhoids
- Patients with the onset of the complaint before 96 hours
Key exclusion criteria (8 listed)
- Patients under the age of 18 and patients over the age of 70
- Mentally retarded patients
- Pregnant patients
- Patients with concomitant proctological disorders (anal fissure, anal fistula, anal abscess, etc.)
- Those with a history of proctology surgery
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 |
|---|---|---|
| Conservative treatmentMicronized purified flavonoid fraction, which is routinely used within indications in hemorrhoidal disease and recommended in ESCP and ASCRS guidelines, and licensed for use in hemorrhoidal disease by the Ministry of Health in our country, was given 2 g/day for one month. Also, Conservative methods (fiber foods, warm shower, regulation of toilet habits, laxatives and nonsteroidal anti-inflammatory drugs) were recommended. | Procedure or surgery | Conservative Treatment Group |
| Surgical TreatmentWhile the patient was in the Jack-knife position, both hips were pulled laterally with tapes, appropriate visualization was obtained, the external thrombosed pack was excised under local anesthesia, and the wound was left to heal with secondary intention.Conservative methods were recommended in the surgical group as well as in the medical group. | Procedure or surgery | Surgical Treatment Group |
Primary outcome
Pain score with visual analog scale
Time frame: 12 hours
The participants pain at the 12th hour postoperatively was scored with a visual analog scale. The visual analog scale was between 0 and 10 mm. 0 rated as no pain, 10 as very severe pain.
3 secondary outcomes
Time to return to daily activities
Time frame: 15 days
Recurrence
Time frame: 6 months
Satisfaction survey
Time frame: 6 months
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 28 Aug 2023.
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.
Hasan Yaldız, MD principal investigator
Konya City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhoids External Thrombosed, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 8 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 28 Aug 2023. 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 Turkey (Türkiye). 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 score with visual analog scale (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2023.