[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658338":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":34,"studyPopulation":26,"armGroups":35,"interventions":42,"overallOfficials":26,"centralContacts":48,"locations":26,"responsibleParty":54,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":26,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":72,"conditions":73,"keywords":26,"overallStatus":76,"whyStopped":26,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":26},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of Participants Achieving Overall Clinical Success","Overall success is a composite endpoint defined by achieving both functional improvement and anatomical patency. Functional success requires clinically meaningful resolution or marked improvement of epiphora, indicated by achieving a Munk score of 0 or 1. Anatomical success requires objective patency of the surgically created rhinostomy, demonstrated by nasal endoscopy and successful lacrimal irrigation without evidence of clinically significant restenosis. A patient must meet both criteria to be considered an overall success, avoiding overestimation based on anatomy alone.","12 months postoperative",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Number of Participants Achieving Anatomical Success","Anatomical success is defined as a patent rhinostomy on endoscopic examination with free or satisfactory lacrimal irrigation and no clinically significant obstructing granulation, fibrosis, or synechiae.","1 week, 1 month, 3 months, 6 months, and 12 months postoperative",{"measure":19,"description":20,"timeFrame":21},"Number of Participants Achieving Functional Success","Functional success is defined by the substantial improvement or resolution of epiphora, indicated by achieving a Munk Epiphora Score of 0 or 1. The Munk Epiphora Score is a grading scale used to quantify tearing severity. The scale ranges from 0 to 4, where 0 indicates no epiphora and 4 indicates constant, severe epiphora requiring wiping 10 or more times a day. Higher scores indicate worse outcomes (more severe tearing).","Baseline, 1 month, 3 months, 6 months, and 12 months postoperative",{"measure":23,"description":24,"timeFrame":25},"Mean Lacrimal Symptom Questionnaire (Lac-Q) Score","Assessment of the social impact and disease-specific quality of life using the Lacrimal Symptom Questionnaire (Lac-Q) to evaluate patient-reported outcomes and symptom improvement. The Lac-Q score ranges from 0 to 14 \\[(Note: adjust these min\u002Fmax numbers if your specific modified version of the Lac-Q differs)\\], where higher scores indicate a worse outcome (greater negative impact on quality of life and more severe symptoms).","Baseline, 3 months, and 12 months postoperative",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":30,"primaryPurpose":31,"observationalModel":26,"timePerspective":26,"maskingInfo":32},"NA","SINGLE_GROUP","This is a prospective, single-arm clinical study designed to evaluate the outcomes of a primary stentless endoscopic dacryocystorhinostomy (En-DCR) without a comparator group.","TREATMENT",{"masking":33,"maskingDescription":26,"whoMasked":26},"NONE","Primary acquired nasolacrimal duct obstruction (PANDO) is a common cause of persistent epiphora and recurrent lacrimal sac inflammation in adults, resulting from chronic inflammatory remodeling, fibrosis, and progressive narrowing of the distal lacrimal drainage system. Beyond physical discomfort, this condition can substantially interfere with daily activities such as reading, driving, outdoor activities, and social interaction. Endoscopic dacryocystorhinostomy (En-DCR) is a surgical treatment that bypasses the obstructed drainage pathway by creating a permanent communication directly between the lacrimal sac and the nasal cavity. Compared to traditional external approaches, En-DCR avoids a cutaneous incision, preserves the medial canthal anatomy, and allows for direct visualization and simultaneous management of relevant intranasal pathology. Historically, many surgeons have routinely placed silicone stents through the newly created rhinostomy to maintain patency and prevent soft-tissue stenosis during the healing phase. However, the routine use of silicone intubation in primary, uncomplicated cases remains a subject of ongoing clinical debate. Because stents act as foreign bodies, they carry inherent risks, including local mucosal irritation, tube displacement, punctal or canalicular trauma, granuloma formation, and corneal abrasion. Furthermore, stenting increases procedural costs and necessitates a dedicated follow-up visit for tube removal. This study operates on the rationale that the essential determinants of a successful En-DCR are the creation of an adequate bypass and favorable wound healing, rather than the temporary presence of a foreign body. Modern endoscopic techniques enable precise bony osteotomies, complete sac exposure, and meticulous mucosal flap preservation. By prioritizing the wide marsupialization of the lacrimal sac and implementing structured postoperative endoscopic care, the need for routine silicone intubation may be effectively eliminated for carefully selected patients. Participants enrolled in this study will undergo a standardized, stentless En-DCR. The surgical protocol emphasizes exposing the lacrimal bone and frontal process of the maxilla, creating a broad and dependent bony osteotomy, opening the lacrimal sac longitudinally, and preserving mucosal flaps for precise apposition without the insertion of bicanalicular or monocanalicular stents. Standardized postoperative management will involve targeted topical nasal saline irrigations and structured clinical visits for endoscopic cleaning, debridement, and the office-based management of any granulation tissue or synechiae as clinically indicated. By systematically documenting both subjective symptom resolution and objective endoscopic healing, this study seeks to provide robust clinical evidence detailing the healing patterns, failure mechanisms, and overall durability of stentless En-DCR.",[36],{"label":37,"type":38,"description":39,"interventionNames":40},"Stentless Endoscopic Dacryocystorhinostomy (En-DCR)","EXPERIMENTAL","Participants in this arm will undergo a primary endoscopic dacryocystorhinostomy (En-DCR) without the routine insertion of a silicone bicanalicular or monocanalicular stent. The standardized surgical procedure includes the creation of a mucosal flap, a sufficiently wide bony osteotomy, longitudinal opening of the lacrimal sac, and wide marsupialization of the sac mucosa into the nasal cavity.",[41],"Procedure: Stentless Endoscopic Dacryocystorhinostomy",[43],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":26},"PROCEDURE","Stentless Endoscopic Dacryocystorhinostomy","The intervention consists of a primary endoscopic dacryocystorhinostomy (En-DCR) performed without the routine insertion of a silicone bicanalicular or monocanalicular stent. The standardized surgical technique involves endoscopic localization of the lacrimal sac, creation of a mucosal flap, and a wide bony osteotomy to expose the lacrimal bone and frontal process of the maxilla. The lacrimal sac is opened longitudinally and widely marsupialized into the nasal cavity, prioritizing mucosal flap preservation and precise apposition without placing a tube. This technique relies on adequate osteotomy, sac marsupialization, mucosal healing, and structured postoperative endoscopic care rather than a permanent foreign body to maintain a functional rhinostomy.",[37],[49],{"name":50,"role":51,"phone":52,"phoneExt":26,"email":53},"Mahmoud Hasan Ali, master degree","CONTACT","201062805374","mahmoud.nwawa@gmail.com",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Mahmoud Hassan Ali","dr","100658338","outcomes-of-stentless-dacryocystorhinostomy-in-primary-acquired-nasolacrimal-duct-obstruction-100658338",false,"NCT07848932","Outcomes of Stentless Dacryocystorhinostomy in Primary Acquired Nasolacrimal Duct Obstruction.","Outcomes of Stentless Dacryocystorhinostomy in Primary Acquired Nasolacrimal Duct Obstruction","Inclusion Criteria:\n\nAge 16 years or older\n\nSymptoms compatible with lacrimal drainage obstruction, particularly persistent epiphora, for at least 3 months\n\nObjective evidence of primary acquired nasolacrimal duct obstruction (PANDO) by lacrimal irrigation\u002Fprobing and\u002For an accepted lacrimal functional test\n\nIndication for primary dacryocystorhinostomy (DCR) after clinical assessment\n\nAbility to provide informed consent\n\nAbility and willingness to attend the scheduled postoperative visits\n\nExclusion Criteria:\n\nPrevious ipsilateral DCR or other lacrimal drainage surgery\n\nCanalicular or punctal stenosis that independently prevents adequate lacrimal drainage\n\nCongenital nasolacrimal duct obstruction\n\nTraumatic, iatrogenic, neoplastic, granulomatous, or other secondary nasolacrimal duct obstruction\n\nActive uncontrolled acute dacryocystitis at the time of surgery\n\nKnown lacrimal sac or nasal malignancy\n\nPrevious major sinonasal surgery likely to substantially alter the lacrimal anatomy\n\nSevere uncontrolled sinonasal inflammatory disease requiring treatment before DCR\n\nSevere bleeding disorder or contraindication to surgery\n\nInability to comply with postoperative assessment","ALL","16 Years",{"count":68,"type":69},40,"ESTIMATED","INTERVENTIONAL",[28],"This prospective, single-arm interventional clinical study aims to evaluate the short- and intermediate-term anatomical, functional, and quality-of-life outcomes of primary stentless endoscopic dacryocystorhinostomy (En-DCR) in adult patients with primary acquired nasolacrimal duct obstruction (PANDO). Endoscopic DCR bypasses the obstructed distal lacrimal drainage pathway by creating a permanent communication between the lacrimal sac and the nasal cavity. While silicone intubation is traditionally used to prevent early restenosis, its routine use remains controversial due to potential foreign-body morbidity, including canalicular trauma, granuloma formation, tube displacement, and the necessity for a secondary removal procedure. The rationale for this study is based on the concept that surgical success is determined by adequate osteotomy, wide sac marsupialization, mucosal flap preservation, and structured postoperative care, rather than the presence of a permanent foreign body. The study will recruit approximately 40 eligible adults (aged $\\\\ge$16 years) with objectively confirmed, symptomatic PANDO to undergo a standardized stentless En-DCR procedure. Participants will undergo rigorous postoperative clinical and endoscopic assessments at 1 week, 1 month, 3 months, 6 months, and 12 months. The primary endpoint is the overall composite success rate at 12 months, defined by both objective anatomical patency of the rhinostomy (verified via endoscopy and lacrimal irrigation) and clinically meaningful functional resolution of epiphora (Munk score 0-1). Secondary objectives include quantifying changes in disease-specific quality of life using the Lac-Q questionnaire, documenting postoperative endoscopic healing parameters, and evaluating the incidence and mechanisms of surgical failure or complications.",[74,75],"Nasolacrimal Duct Obstruction","Epiphora","NOT_YET_RECRUITING","2026-09-26",{"date":79,"type":80},"2026-09-30","ACTUAL",{"date":82,"type":69},"2027-01-01",{"date":84,"type":69},"2028-06-01",{"name":5,"class":6}]