Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-29 @ 4:58 PM
Study NCT ID:
NCT05193032
Status:
COMPLETED
Last Update Posted:
2023-03-07
First Post:
2021-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abces After Incision: Recurrence or Not?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-06', 'studyFirstSubmitDate': '2021-12-31', 'studyFirstSubmitQcDate': '2021-12-31', 'lastUpdatePostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of the patients, within 2 years', 'timeFrame': 'Year 2', 'description': 'This outcome corresponds to the rate of occurrence of at least one new abscess, within 2 years, in patients who were treated by a simple skin incision in consultation and/or whose fistula was not found during examination under anesthesia in the operating room.'}], 'secondaryOutcomes': [{'measure': 'Predictive factors for recurrence of abscesses', 'timeFrame': 'Year 2', 'description': 'This outcome corresponds to the Predictive factors for the occurrence of at least one new abscess, within 2 years, in patients who consulted our center for an anal or perianal abscess treated by a simple skin incision in consultation and/or whose fistula was not found during the examination under anesthesia in the operating room.'}, {'measure': 'Patient care', 'timeFrame': 'Year 2', 'description': 'This outcome corresponds to the Description of the management (imaging, surgical techniques, number of surgical procedures) of patients who were operated on under anesthesia in the operating room and whose fistula was found.'}, {'measure': 'Cure rate', 'timeFrame': 'Year 2', 'description': 'This outcome corresponds to the Healing and anal incontinence rates of patients who were operated on under anesthesia in the operating room and whose fistula was found.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anal Abscess', 'Perianal Abscess']}, 'referencesModule': {'references': [{'pmid': '16317550', 'type': 'BACKGROUND', 'citation': 'Quah HM, Tang CL, Eu KW, Chan SY, Samuel M. Meta-analysis of randomized clinical trials comparing drainage alone vs primary sphincter-cutting procedures for anorectal abscess-fistula. Int J Colorectal Dis. 2006 Sep;21(6):602-9. doi: 10.1007/s00384-005-0060-y. Epub 2005 Nov 30.'}, {'pmid': '20614450', 'type': 'BACKGROUND', 'citation': 'Malik AI, Nelson RL, Tou S. Incision and drainage of perianal abscess with or without treatment of anal fistula. Cochrane Database Syst Rev. 2010 Jul 7;(7):CD006827. doi: 10.1002/14651858.CD006827.pub2.'}, {'pmid': '28857130', 'type': 'BACKGROUND', 'citation': 'Sahnan K, Askari A, Adegbola SO, Tozer PJ, Phillips RKS, Hart A, Faiz OD. Natural history of anorectal sepsis. Br J Surg. 2017 Dec;104(13):1857-1865. doi: 10.1002/bjs.10614. Epub 2017 Aug 31.'}, {'pmid': '30451763', 'type': 'BACKGROUND', 'citation': 'Sahnan K, Askari A, Adegbola SO, Warusavitarne J, Lung PFC, Hart A, Faiz O, Phillips RKS, Tozer P. Persistent Fistula After Anorectal Abscess Drainage: Local Experience of 11 Years. Dis Colon Rectum. 2019 Mar;62(3):327-332. doi: 10.1097/DCR.0000000000001271.'}, {'pmid': '32251145', 'type': 'BACKGROUND', 'citation': 'Sho S, Dawes AJ, Chen FC, Russell MM, Kwaan MR. Operative Incision and Drainage for Perirectal Abscesses: What Are Risk Factors for Prolonged Length of Stay, Reoperation, and Readmission? Dis Colon Rectum. 2020 Aug;63(8):1127-1133. doi: 10.1097/DCR.0000000000001653.'}, {'pmid': '20196412', 'type': 'BACKGROUND', 'citation': 'Lohsiriwat V, Yodying H, Lohsiriwat D. Incidence and factors influencing the development of fistula-in-ano after incision and drainage of perianal abscesses. J Med Assoc Thai. 2010 Jan;93(1):61-5.'}, {'pmid': '32375721', 'type': 'BACKGROUND', 'citation': 'He Z, Du J, Wu K, Chen J, Wu B, Yang J, Xu Z, Fu Z, Pan L, Wen K, Wang X. Formation rate of secondary anal fistula after incision and drainage of perianal Sepsis and analysis of risk factors. BMC Surg. 2020 May 6;20(1):94. doi: 10.1186/s12893-020-00762-3.'}, {'pmid': '30773213', 'type': 'BACKGROUND', 'citation': 'Mocanu V, Dang JT, Ladak F, Tian C, Wang H, Birch DW, Karmali S. Antibiotic use in prevention of anal fistulas following incision and drainage of anorectal abscesses: A systematic review and meta-analysis. Am J Surg. 2019 May;217(5):910-917. doi: 10.1016/j.amjsurg.2019.01.015. Epub 2019 Jan 31.'}]}, 'descriptionModule': {'briefSummary': 'The French School of Proctology assumes that any anal or perianal abscess is related to an anal fistula and therefore requires treatment at the risk of recurrence of the abscess. The Anglo-Saxons, on the other hand, recommend a simple incision in case of a first abscess, without taking care of the possible fistula, on the grounds that more than 60% of patients will not have a recurrence of their abscess. In addition, predictive factors of abscess recurrence have been reported such as female gender, age over 40 years, however, contradicted by other studies. High BMI, corticosteroid use, Crohn\'s disease are other predictive factors of recurrence while diabetes mellitus or antibiotic therapy during the days following the incision were considered as "protective". The objective of this study was to evaluate our experience in the hospital with essentially a description of the evolution of the patients in the 2 years following the incision of the abscess in consultation.\n\nThe main objective is to describe the evolution of patients, within 2 years, who consulted our center for an anal or perianal abscess treated by a simple skin incision under local anesthesia in consultation and/or whose fistula was not found during the examination under anesthesia in the operating room.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients managed at the center for anal or perianal abscesses treated with a simple skin incision under local anesthesia in consultation and/or whose fistula was not found during examination under anesthesia in the operating room, between January 1, 2019 and December 31, 2019', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient whose age ≥ 18 years\n* Patient who visited between January 1, 2019 and December 31, 2019 for an anal or perianal abscess\n* Patient who had a skin incision of a first anal margin or buttock abscess and/or whose fistula was not found during examination under anesthesia in the operating room\n* French speaking patient\n\nExclusion Criteria:\n\n* Patient with pilonidal abscess\n* Patient with an intramural abscess\n* Patient with a history of anal margin or buttock abscess and/or anal fistula\n* Patient with a history of proctologic surgery\n* Patient with an abscess whose skin incision under local anesthesia has failed\n* Patient under guardianship or curatorship\n* Patient deprived of liberty\n* Patient under court protection\n* Patient objecting to the use of his or her data for this research'}, 'identificationModule': {'nctId': 'NCT05193032', 'acronym': 'ABCINCIS', 'briefTitle': 'Abces After Incision: Recurrence or Not?', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Hôpital Saint-Joseph'}, 'officialTitle': 'Abces After Incision: Recurrence or Not?', 'orgStudyIdInfo': {'id': 'ABCINCIS'}}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Paris Saint-Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Amine ALAM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Hôpital Saint-Joseph'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Hôpital Saint-Joseph', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}