Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-02-21 @ 6:24 AM
Study NCT ID:
NCT00534768
Status:
COMPLETED
Last Update Posted:
2008-01-14
First Post:
2007-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Treatment After Endoscopic Sinus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012852', 'term': 'Sinusitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'lastUpdateSubmitDate': '2008-01-11', 'studyFirstSubmitDate': '2007-09-24', 'studyFirstSubmitQcDate': '2007-09-24', 'lastUpdatePostDateStruct': {'date': '2008-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'scarring in middle meatus 4 weeks after ESS', 'timeFrame': '4 weeks'}]}, 'conditionsModule': {'conditions': ['Sinusitis']}, 'descriptionModule': {'briefSummary': 'Objective: Even though postoperative debridement is commonly considered as an essential part of endoscopic sinus surgery (ESS), the scientific data on the efficacy or the optimal timing of debridement is limited. In the present study, the effect of repeated debridement during the first week after ESS on the endoscopic and subjective outcome was evaluated.\n\nStudy Design: Open, prospective, randomized, controlled clinical trial with two parallel groups.\n\nMethods: A total of 90 patients suffering from either recurrent or chronic maxillary sinusitis were randomized into two groups after ESS. In the active group, the nasal cavities were debrided three times on the first postoperative week, while in the control group the patients were debrided only once on the 7th postoperative day. The primary outcome measure was the presence of scarring in the middle meatus at four weeks after ESS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A total of 90 patients (age 18-70 years), who underwent ESS in Kuopio University Hospital, Kuopio, Finland were included in this study.\n* The patients suffered from either recurrent or chronic maxillary sinusitis and had American Society of Anaesthesiologists physical status 1 or 2.{{331 Sakland,M. 1941; }}\n\nExclusion Criteria:\n\nThe patients were excluded if they had:\n\n* Undergone previous sinus surgery or if they had severe nasal polyposis (radiological opacification more than 50 % of the sinuses (Lund-McKay classification)\n* Hemorrhagic diathesis\n* Liver or kidney dysfunction\n* Chronic malnutrition\n* Alcoholism or inflammatory bowel disease.\n\nOther exclusion criteria were pregnancy and ongoing anticoagulant therapy.'}, 'identificationModule': {'nctId': 'NCT00534768', 'briefTitle': 'Postoperative Treatment After Endoscopic Sinus Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'officialTitle': 'Postoperative Treatment After Endoscopic Sinus Surgery', 'orgStudyIdInfo': {'id': 'KUH5551813'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'debridement on 1st, 3-5th and 7th postoperative days', 'interventionNames': ['Procedure: active debridement']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Procedure: control group']}], 'interventions': [{'name': 'active debridement', 'type': 'PROCEDURE', 'description': 'debridement on 1st, 3-5th and 7th postoperative days', 'armGroupLabels': ['1']}, {'name': 'control group', 'type': 'PROCEDURE', 'description': 'Postoperative debridement on 7th postoperative day', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kuopio', 'country': 'Finland', 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}], 'overallOfficials': [{'name': 'Tatu p Kemppainen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kuopio University Hospital'}, {'name': 'Juhani Nuutinen, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kuopio University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}}}}