Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-26 @ 1:42 PM
Study NCT ID:
NCT04588467
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2020-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Thrombosed Haemorrhoids in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-10-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-14', 'studyFirstSubmitDate': '2020-10-08', 'studyFirstSubmitQcDate': '2020-10-14', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain evaluation: scale', 'timeFrame': '10 days', 'description': 'A scale of pain will be administered to patients'}, {'measure': 'Quality of Life evaluation: questionnaire', 'timeFrame': '10 days', 'description': 'A questionnaire of quality of life will be administered to patients after the treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Haemorrhoidal Crisis', 'Pregnancy Related']}, 'referencesModule': {'references': [{'pmid': '38151682', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Thrombosis of the external hemorrhoids (TEH) is one of the most frequent complain during pregnancy, particularly during the third trimester.\n\nThe paucity of the medical literature on this topic has recently been underlined in the European guidelines for hemorrhoid treatment .\n\nThe aim of this prospective study is to compare the efficacy and safety of conservative versus surgical treatment of TEH in pregnant women', 'detailedDescription': "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.\n\nSystemic 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.\n\nTreatment 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.\n\nIn 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.\n\nDuring the pregnancy the administration of conservative medications is quite limited due to the possible side effect of such drugs on the fetus.\n\nThe 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnancy\n* Thrombosed external haemorrhoids\n* Written consent\n\nExclusion Criteria:\n\n* Inflammatory bowel disease\n* Cancer\n* Age lower than 18 years old'}, 'identificationModule': {'nctId': 'NCT04588467', 'briefTitle': 'Treatment of Thrombosed Haemorrhoids in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Russian Society of Colorectal Surgeons'}, 'officialTitle': 'Thrombosed External Haemorrhoids During Pregnancy: Surgery Versus Conservative Treatment', 'orgStudyIdInfo': {'id': '6835447'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conservative group', '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', 'interventionNames': ['Other: Medical treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Surgical group', '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', 'interventionNames': ['Procedure: Surgical treatment']}], 'interventions': [{'name': 'Medical treatment', 'type': 'OTHER', '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', 'armGroupLabels': ['Conservative group']}, {'name': 'Surgical treatment', 'type': 'PROCEDURE', 'description': 'Pregnant women complaining thrombosed haemorrhoids will receive local excision or thrombectomy under local anesthesia', 'armGroupLabels': ['Surgical group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119435', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Clinic of Colorectal and Minimally invasive surgery', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Inna Tulina, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Russian Society of Colorectal Surgeons'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Russian Society of Colorectal Surgeons', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}