Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 9:09 PM
Study NCT ID:
NCT06009133
Status:
COMPLETED
Last Update Posted:
2023-08-28
First Post:
2023-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Approach for Acute External Thrombosed Hemorrhoidal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072700', 'term': 'Conservative Treatment'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-24', 'studyFirstSubmitDate': '2023-08-17', 'studyFirstSubmitQcDate': '2023-08-18', 'lastUpdatePostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score with visual analog scale', 'timeFrame': '12 hours', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Time to return to daily activities', 'timeFrame': '15 days', 'description': "The patients' return to daily activities were recorded."}, {'measure': 'Recurrence', 'timeFrame': '6 months', 'description': 'It was recorded whether the patients had hemorrhoid recurrence at 6 months.'}, {'measure': 'Satisfaction survey', 'timeFrame': '6 months', 'description': '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.\n\nSatisfaction questionnaire was applied to the patients at 6 months.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemorrhoids External Thrombosed']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nWhile 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.\n\nAETHD 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 .\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between the ages of 18-70 who present with isolated external thrombosed hemorrhoids\n* Patients with the onset of the complaint before 96 hours\n\nExclusion Criteria:\n\nPatients under the age of 18 and patients over the age of 70\n\n* Mentally retarded patients\n* Pregnant patients\n* Patients with concomitant proctological disorders (anal fissure, anal fistula, anal abscess, etc.)\n\nThose with a history of proctology surgery\n\n* Patients with grade 3-4 internal hemorrhoids\n* Patients using anticoagulant drugs\n* Patients whose complaint has passed 96 hours after onset'}, 'identificationModule': {'nctId': 'NCT06009133', 'briefTitle': 'Surgical Approach for Acute External Thrombosed Hemorrhoidal Disease', 'organization': {'class': 'OTHER', 'fullName': 'Konya Meram State Hospital'}, 'officialTitle': 'Surgical Excision Versus Medical Treatment in Acute External Thrombosed Hemorrhoidal Disease', 'orgStudyIdInfo': {'id': 'Konya HH Group'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Conservative Treatment Group', 'description': '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.\n\nAlso, Conservative methods (fiber foods, warm shower, regulation of toilet habits, laxatives and nonsteroidal anti-inflammatory drugs) were recommended.', 'interventionNames': ['Procedure: Conservative treatment']}, {'label': 'Surgical Treatment Group', 'description': '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.', 'interventionNames': ['Procedure: Surgical Treatment']}], 'interventions': [{'name': 'Conservative treatment', 'type': 'PROCEDURE', 'description': '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.\n\nAlso, Conservative methods (fiber foods, warm shower, regulation of toilet habits, laxatives and nonsteroidal anti-inflammatory drugs) were recommended.', 'armGroupLabels': ['Conservative Treatment Group']}, {'name': 'Surgical Treatment', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Surgical Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42090', 'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Konya Training and Research Hospital', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}], 'overallOfficials': [{'name': 'Hasan Yaldız, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Konya City Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konya Meram State Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Alpaslan Şahin', 'investigatorAffiliation': 'Konya Meram State Hospital'}}}}